[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-receptor-positive-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-receptor-positive-tumor":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,73,108,147,172,198,232,265,288],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100633256","phase-1-study-of-rgt-490-in-patients-with-pik3ca-mutated-advanced-solid-tumors-100633256",false,"NCT07524322","Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors","A Phase 1\u002F1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+\u002FHER2- Breast Cancers","Inclusion Criteria:\n\n* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.\n* Presence of one or more documented activating PIK3CA mutation in tumor tissue and\u002For blood.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diabetes mellitus requiring anti-hyperglycemic medication.\n* Prior treatment with PI3Kα inhibitors\n* Symptomatic, untreated, or uncontrolled central nervous system metastases.\n* Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.\n* Unresolved clinically significant toxicities from prior anticancer therapy\n* History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).","ALL","18 Years",{"count":19,"type":20},63,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1\u002F1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.\n\nParticipants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.",[26,27,28,29,30,31,32,33,34],"Breast Cancer","Ovarian Cancer","Endometrial Cancer","PIK3CA Mutation","HER2- Negative Breast Cancer","Advanced Breast Cancer","Unresectable Solid Tumor","Hormone Receptor Positive Tumor","Cervical Cancer","RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":20},"2026-06",{"date":43,"type":20},"2028-10",{"name":45,"class":46},"Regor Pharmaceuticals Inc.","INDUSTRY",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100591599","phase-3-phase-3-study-of-rly-2608--fulvestrant-vs-capivasertib--fulvestrant-as-treatment-for-locally-advanced-or-metastatic-pik3ca-mutant-hrher2--breast-cancer-100591599","NCT06982521","Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+\u002FHER2- Breast Cancer","A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+\u002FHER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4\u002F6 Inhibitor","ReDiscover-2","Inclusion Criteria:\n\n* Patient has ECOG performance status of 0-1\n* One or more known primary oncogenic PIK3CA mutation(s)\n* Adult females, pre- and\u002For post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing hormone (GnRH) agonist. Patients are to have commenced treatment with a GnRH agonist at least 4 weeks prior to randomization and must be willing to continue on it for the duration of the study.\n* Histologically or cytologically confirmed diagnosis of HR+\u002FHER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent\n* Measurable disease per RECIST v1.1 or evaluable bone-only disease.\n* Must have radiological evidence of progression on or after previous treatment for HR+\u002FHER2- ABC with:\n\n  1. At least 1 and no more than 2 lines of endocrine therapy (ET) in the (neo)adjuvant setting with recurrence on or within 12 months of completion or in the ABC setting\n  2. 1 prior line of CDK4\u002F6 inhibitor therapy in one of the following settings:\n\n     1. CDK4\u002F6 inhibitor + ET in the ABC setting\n     2. CDK4\u002F6 inhibitor therapy in the adjuvant setting if progression occurred during or within 12 months of completion of adjuvant CDK4\u002F6 inhibitor with ET\n     3. Patients who progressed during or within 12 months of completion of adjuvant CDK4\u002F6 inhibitor and after receiving CDK4\u002F6 inhibitor therapy in the advanced setting are considered to have had \\>1 prior line of CDK4\u002F6 inhibitor and are not eligible\n\nExclusion Criteria:\n\n* Prior treatment with any of the following:\n\n  1. CDK2 or selective CDK4 inhibitors or any investigational therapies targeting cyclin dependent kinases\n  2. PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3\u002FAKT\u002FmTOR pathway\n  3. Immunotherapy\n  4. Antibody drug conjugates\n* Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg\u002FdL, or glycosylated hemoglobin (HbA1c) ≥7.0% (≥ 53 mmol\u002Fmol).\n* Clinically significant, uncontrolled cardiovascular disease\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events\n* Known active uncontrolled or symptomatic CNS metastases associated with progressive neurological symptoms or requiring ongoing corticosteroids or anticonvulsants for symptomatic control\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n* History of hypersensitivity to fulvestrant or drugs in a similar class as fulvestrant, RLY-2608, or capivasertib, including their excipients\n* Known activating AKT mutations, loss-of-function PTEN mutations, or loss of PTEN expression resulting in oncogenic pathway activation downstream of PI3K",{"count":57,"type":20},540,[59],"PHASE3","This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+\u002FHER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4\u002F6 inhibitor.",[29,30,33,26,62,31],"Metastatic Breast Cancer","2026-06-10",{"date":65,"type":39},"2026-06-11",{"date":67,"type":39},"2025-08-26",{"date":69,"type":20},"2031-12-31",{"name":71,"class":46},"Relay Therapeutics, Inc.",192,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":81,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100484012","phase-2-fudan-university-shanghai-cancer-center-breast-cancer-precision-platform-series-study--neoadjuvant-therapy-100484012","NCT05582499","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)","FASCINATE-N","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;\n* Age between18-70 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* ER, PR and HER2 status were measured by immunohistochemistry (IHC);\n* LVEF≥55%；\n* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\\&E slices;\n* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;\n* At least one measurable lesion according to RECIST version 1.1\n* Normal organ and marrow function: Hemoglobin (HB) ≥90 g\u002FL (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 75,000\u002FμL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \\\u003C 1 x ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;\n* Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;\n* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);\n* Patients with severe systemic infections or other serious diseases;\n* Patients with known allergy or intolerance to the study drug or its excipients;\n* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;\n* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;\n* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;\n* Patients who were judged by the investigator to be unsuitable for this study.","FEMALE","70 Years",{"count":84,"type":20},716,[86],"PHASE2","The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.",[89,26,90,91,92,93,33,94,95,96],"Breast Neoplasm","Breast Tumors","Triple-Negative Breast Cancer (TNBC)","HER2-positive Breast Cancer","HER2-negative Breast Cancer","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","Locally Advanced Breast Cancer","2026-05-22",{"date":99,"type":39},"2026-05-28",{"date":101,"type":39},"2022-11-01",{"date":103,"type":20},"2029-09",{"name":105,"class":106},"Fudan University","OTHER",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100136130","phase-2-i-spy-trial-neoadjuvant-and-personalized-adaptive-novel-agents-to-treat-breast-cancer-100136130","NCT01042379","I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)","I-SPY","Inclusion Criteria:\n\n* Histologically confirmed invasive cancer of the breast\n* Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)\n* No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed\n* Age ≥18 years\n* ECOG performance status 0-1\n* Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers\n* Non-pregnant and non-lactating\n* No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.\n* Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)\n* Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis\n* Any tumor ER\u002FPgR status, any HER-2\u002Fneu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F\n* Normal organ and marrow function: Leukocytes ≥ 3000\u002FμL, Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)\u002FALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \\\u003C 1.5 x institutional ULN\n* No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%\n* No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase\n* Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\\\u003C5%), any HER2 status, or MammaPrint Low, ER positive, HER2\u002Fneu positive by any one of the three methods used (IHC, FISH, TargetPrint™)\n* Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)\n\nExclusion Criteria:\n\n* Use of any other investigational agents within 30 days of starting study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":117,"type":20},5000,[86],"The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.",[121,26,90,122,123,92,93,33,94,95,96],"Breast Neoplasms","Angiosarcoma","TNBC - Triple-Negative Breast Cancer",[125,126,127,128,129,130,131,132,133,134,135,136],"Neoadjuvant","Breast","Cancer","Neoplasm","Adaptive","pCR","Pathologic Complete Response","Biomarkers signature","MRI Volume","Endocrine Therapy","Chemotherapy","Immunotherapy","2026-05-04",{"date":139,"type":39},"2026-05-06",{"date":141,"type":39},"2010-03-01",{"date":143,"type":20},"2031-12",{"name":145,"class":106},"QuantumLeap Healthcare Collaborative",42,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":81,"minAge":155,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100514714","phase-2-elacestrant-withwithout-triptorelin-in-premenopausal-women-with-luminal-breast-cancer-100514714","NCT05982093","Elacestrant With\u002FWithout Triptorelin in Premenopausal Women With Luminal Breast Cancer","A Phase 2 Randomized Pre-operative,Window of Opportunity Trial Investigating the Effect of Elacestrant With\u002FWithout Triptorelin in Premenopausal Patients With HR+\u002FHER2- Breast Cancer - SOLTI-2104-PremiÈRe Trial.","SOLTI-2104","Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to any trial-specific procedure.\n2. Female patients who are at least 35 years of age on the day of signing informed consent.\n3. Patient is premenopausal at the time of study entry\n\n   Premenopausal status is defined as either:\n   * Patient had last menstrual period within the last 6 months. OR\n   * Plasma estradiol and FSH in the premenopausal range, according to local laboratory definition.\n\n   Note: Patients who have undergone bilateral oophorectomy are not eligible.\n4. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed, with all the following characteristics:\n\n   * Stage I to stage IIB operable breast cancer (7th Edition of the AJCC). Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy. This procedure at screening will be omitted if there is no suspicion for positive axillary lymph node(s) radiographically or if a pathological report of suspicious lymph nodes of the results of a fine needle biopsy or core biopsy is available prior to the screening period.\n   * Absence of distant metastasis (i.e., M0) as determined by institutional practice.\n   * At least 1 lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 10 mm as measured by magnetic resonance imaging (MRI) or ultrasound (US).\n   * In the case of a multifocal tumor, the largest lesion must be ≥ 10 mm and designated the \"target\" lesion for all subsequent tumor evaluations. All biopsied tumors had to be ER+HER2-negative\n5. ER-positive with expression higher than 10% and HER2-negative tumor\n\n   * HER2 negativity is defined as either of the following: Immunohistochemistry (IHC) 0, IHC 1+ or IHC2+\u002Fin situ hybridization (ISH) negative as per most recent American Society of Clinical Oncology (ASCO)-College of American Pathologists Guideline (CAP) guideline according to the local laboratory as determined on the most recently analyzed tissue sample.\n   * Documentation of ER positive tumor with ≥ 10% staining by immunohistochemistry of cells as per most recent ASCO-CAP guideline according to the local laboratory determined on the most recently analyzed tissue sample, with or without progesterone receptor positivity.\n6. Ki67 expression ≥ 10% and ≤ 35% by local assessment\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n8. Breast cancer eligible for primary surgery.\n9. Availability of pre-treatment tumor tissue sample of FFPE tumor block from primary tumor for biomarker analysis. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to enrollment. Archival tumor tissue or ex professo biopsy are acceptable.\n10. Adequate hematologic and organ function within 14 days before the first study treatment on Day 1, defined by the following:\n\n    1. Neutrophils (ANC ≥1.000\u002FμL).\n    2. Hemoglobin ≥ 9.0 g\u002FdL (with no need for transfusions).\n    3. Platelet count ≥ 75. 000\u002FμL.\n    4. Serum creatinine ≤1.5 mg\u002FdL or calculated creatinine clearance ≥30 mL\u002Fmin (Cockcroft-Gault Equation)\n    5. International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) within therapeutic range.\n\n       Note: Subjects who are receiving anticoagulation treatment which is monitored by INR (eg, warfarin) may be allowed to participate if they have a stable INR (ie, within therapeutic range) for at least 28 days prior to the first dose of study drug, in the absence of any exclusionary medical conditions, and provided that elacestrant would be appropriate therapy for the subject\n    6. Potassium, total Calcium (corrected for serum albumin), and sodium NCI CTCAE v5.0 Grade ≤ 1.\n    7. Alanine aminotransferase (ALT) ≤ 3x upper limit of normal (ULN)\n    8. Aspartate aminotransferase (AST) ≤ 3x ULN\n    9. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome\n11. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n12. Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test within 7 days prior to randomization.\n13. Female subjects must not donate, or retrieve for their own use, oocytes from the time of screening and throughout the study treatment period, and for at least 120 days after the time of final study drug administration.\n14. Women of CBP must be willing to use highly effective methods of contraception. Contraception must continue during the trial treatment and after stopping the treatment received according to protocol. Highly effective contraception methods include:\n\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Placement of a non-hormonal intrauterine device (IUD). Notes: Use of oral (estrogen and progesterone), transdermal, injected, implanted, hormone containing intrauterine system, or any other hormonal methods of contraception is not allowed in this trial. Women are considered of CBP unless: they have had ≥ 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age-appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least four weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment, she will be considered not of CBP. After the end of trial treatment, patients should use effective contraception at least until 28 days after therapy discontinuation.\n15. Patients must have the ability to swallow oral medication.\n\nExclusion Criteria:\n\n1. Inoperable locally advanced or inflammatory breast cancer (any stage III).\n2. Metastatic (Stage IV) breast cancer.\n3. Synchronous invasive bilateral or multicentric breast cancer.\n4. Patients requiring immediate neoadjuvant chemotherapy or immediate surgical intervention.\n5. Patients who have undergone sentinel lymph node biopsy or tumor excisional biopsy prior to study treatment.\n6. Prior malignancy within 3 years prior to randomization, except curatively treated non-melanoma skin cancer, in situ cancer or adequately and curatively treated Stage I or II cancer from which the patient is currently in complete remission.\n7. Patients currently on following medications, which cannot be interrupted 7 days prior treatment start:\n\n   * Any prohibited medication as per decapeptyl (triptorelin) label\n   * Strong inhibitors of CYP3A4, including grapefruit, grapefruit hybrids, pummelos, starfruit and Seville oranges\n   * Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (Refer to http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002F) within 5 half-life of the drug prior to initiating trial therapy\n   * Herbal preparations\u002Fmedications. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 5 half-life of the drug prior to initiating trial therapy\n   * Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to randomization.\n8. Any treatment, local or systemic, including prior chemotherapy, ET, targeted therapy, and\u002For radiation therapy for the currently diagnosed BC prior to enrollment.\n9. Major surgical procedure or significant traumatic injury within 28 days prior to randomization.\n10. Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol.\n11. Any of the following within 6 months before enrollment: myocardial infarction, severe\u002Funstable angina, ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade ≥ 2, prolonged QTcF ≥ Grade 2 (i.e., \\> 480 msec), uncontrolled atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, heart failure ≥ Class II as defined by the New York Heart Association guidelines, or cerebrovascular accident including transient ischemic attack.\n12. Child-Pugh Score greater than Class A (i.e., score \\>6)\n13. Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism. However, subjects with the following conditions will be allowed to participate:\n\n    1. Adequately treated catheter-related venous thrombosis occurring \\>28 days prior to the first dose of study drug\n    2. Treatment with an anticoagulant, e.g., warfarin or heparin, for a thrombotic event occurring \\> 6 months before enrollment, or for an otherwise stable and allowed medical condition (eg, well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are in therapeutic range prior to the first dose of study drug and provided that an AI would be an appropriate therapy for the subject\n14. Known hypersensitivity to any of the study drugs, including excipients.\n15. Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass.\n16. History of or clinical evidence of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent.\n17. Previous hormonal treatments for other indications such as osteoporosis, breast cancer prevention, hormonal substitutive therapy, such as raloxifene, tamoxifen, estrogen, progestins must have ended at least 12 months prior to trial registration. If a patient is on natural products known to contain progestins, they must be stopped 14 days prior to beginning study treatment.\n18. Used any prescription medication during the prior 1 month that the investigator judge is likely to interfere with the study or to pose an additional risk to the patient in participating.\n19. Female subject who is pregnant or breastfeeding or intends to become pregnant during the study.","35 Years",{"count":157,"type":20},96,[86],"PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+\u002FHER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.",[26,93,33,161],"Premenopausal Breast Cancer","2026-04-21",{"date":164,"type":39},"2026-04-24",{"date":166,"type":39},"2023-02-03",{"date":168,"type":20},"2026-12",{"name":170,"class":106},"SOLTI Breast Cancer Research Group",15,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":81,"minAge":179,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100609734","a-study-of-the-therabionic-p1-device-in-breast-cancer-100609734","NCT07218432","A Study of the TheraBionic P1 Device in Breast Cancer","A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting","Inclusion Criteria:\n\n* Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor Receptor 2) negative according to the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (ER and\u002For PR (progesterone receptor) \\>1% and HER2 negative by immunohistochemistry \\[IHC\\] and\u002For fluorescent in situ hybridization \\[FISH\\]).\n* Participant must have early-stage operable disease (stage I-II or III who have planned upfront surgery) and agree to definitive upfront surgery.\n* Participant must be available for at least two weeks of TheraBionic treatment prior to scheduled resection\n* Participant must have archival tissue available.\n* Participant must be a woman aged 22 years or older\n* Participant must be able to understand a written informed consent document and be willing to sign it\n* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session\n\nExclusion Criteria:\n\n* Participants that are receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy\n* Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints\n* Participants that are taking any other investigational drugs\n* Participants that are pregnant or breastfeeding due to the unknown but potential risk for adverse events. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued\n* Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).\n* Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid\u002Fvitamin C, etc.) unless their medical treatment is discontinued at least one day prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study.\n* Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device\n* Participants with a known severe (e.g., anaphylactic) allergy to nickel.","22 Years",{"count":181,"type":20},24,[183],"NA","The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.",[186,187,188,33,93],"Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage IIIA","2026-04-16",{"date":162,"type":39},{"date":192,"type":20},"2026-10",{"date":194,"type":20},"2028-06-30",{"name":196,"class":106},"Barbara Ann Karmanos Cancer Institute",8,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":208,"briefSummary":209,"conditions":210,"keywords":217,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100495736","phase-1-open-label-study-to-evaluate-the-safety-tolerability-pk-and-efficacy-of-inx-315-in-patients-with-advanced-cancer-100495736","NCT05735080","Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer","A Phase 1\u002F2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer","INX-315-01","Inclusion Criteria:\n\n1. Advanced unresectable or metastatic HR+\u002FHER2- BC that has progressed following treatment with a CDK4\u002F6 inhibitor in the adjuvant or advanced\u002Fmetastatic setting.\n2. Advanced\u002F metastatic platinum-resistant or platinum-refractory high grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with known amplification of CCNE-1 that progressed after standard systemic therapy\n3. Advanced or metastatic solid tumor with known amplification of CCNE-1 that has progressed after standard therapy, been intolerant to or is ineligible for standard therapy\n4. At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated\n5. ECOG performance status score of 0 or 1.\n6. Adequate organ function as demonstrated by the following laboratory values:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL\n   2. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n   3. Platelet count ≥ 100 × 10\\^9\u002FL\n   4. Estimated glomerular filtration rate (eGFR) of ≥60 mL\u002Fmin\n   5. Part A and B: Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN in the presence of liver metastases Part C: Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 × ULN and direct bilirubin within normal limits\n7. Negative pregnancy test\n\nExclusion Criteria:\n\n1. Have received previous therapy with a CDK2\u002F4\u002F6 inhibitor or CDK2 inhibitor.\n2. Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires corticosteroids (within 4 weeks of enrollment) to control the CNS disease.\n3. Have known intracranial hemorrhage and\u002For bleeding diatheses.\n4. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.\n5. Have clinically active ongoing interstitial lung disease (ILD) of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment.\n6. Resting QTcF \\> 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.\n7. Uncontrolled, cardiovascular disease (including hypertension) with or without medication\n8. History of other malignancies, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for ≥ 3 years.\n9. Known HIV infection, including AIDS-related illness, or have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus, hepatitis C virus, or COVID-19 infection (symptoms and a positive test result).\n10. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.\n11. Have planned or anticipation of the need for major surgical procedure within 28 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures).\n12. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.\n13. Radical radiotherapy within 28 days prior to study entry or palliative radiotherapy within 2 weeks prior to study entry.\n14. Systemic anti-cancer therapy within 21 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug\n15. Prior irradiation to \\> 25% of the bone marrow\n16. Previous high-dose chemotherapy requiring prior stem cell transplant\n17. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry.\n18. Known or suspected hypersensitivity to active ingredient\u002Fexcipients in INX-315 or fulvestrant or abemaciclib.\n19. Known difficulty in swallowing or tolerating oral medications, or conditions which would impair absorption of oral medications such as active inflammatory gastrointestinal disease, uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder\u002Factive inflammation, malabsorption syndrome, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.\n20. Has a serious and\u002For uncontrolled pre-existing medical condition(s) that, in the judgment of the Investigator or the Sponsor, would preclude participation in this study (for example but not limited to, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)",{"count":207,"type":20},150,[23,86],"Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced\u002Fmetastatic cancer, including hormone receptor positive (HR+)\u002FHuman Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4\u002F6 inhibitor (CDK4\u002F6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. The study will be conducted in 3 parts: Part A (INX-315 monotherapy dose escalation and combination therapy with fulvestrant), Part B (ovarian cancer INX-315 monotherapy dose expansion), and Part C (INX-315 combination therapy with abemaciclib \\[a CDK4\u002F6i\\] and fulvestrant \\[a SERD\\] in advanced\u002Fmetastatic breast cancer; dose escalation and expansion).",[26,211,33,212,27,213,214,215,216],"Breast Cancer Metastatic","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","CCNE1 Amplification","Solid Tumor","Advanced Cancer","Metastatic Cancer",[218,219,220,221],"CDK2","CDK4\u002F6i","cyclin dependent kinase 2","CCNE1","2026-03-27",{"date":224,"type":39},"2026-04-01",{"date":226,"type":39},"2023-03-28",{"date":228,"type":20},"2027-09",{"name":230,"class":46},"Incyclix Bio",18,{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":81,"minAge":17,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":107},"100566072","adherence-to-aromatase-inhibitors--abemaciclib-treatment-in-patients-with-early-stage-her2-negative-breast-cancer-100566072","NCT06650423","Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer","ONCO-ADHER: Adherence to Treatment With Aromatase Inhibitors With or Without Abemaciclib in Patients With Early-stage, Endocrine-dependent, HER2-negative Breast Cancer","ONCO-Adher","Inclusion Criteria:\n\n* Female,\n* Early HR+\u002FHER-2- BC,\n* Patient is receiving adjuvant therapy with an aromatase inhibitor (letrozole, anastrozole or exemestane), with or without a CDK4\u002F6 inhibitor abemaciclib, for no more than 18 months,\n* Treatment of BC is being conducted at OIL,\n* Patient has mandatory health insurance through Health Insurance Institute of Slovenia,\n* Patient understands Slovenian language, and\n* Patient agrees to participate in the study and provides written informed consent.\n\nExclusion Criteria:\n\n* Metastatic HR+\u002FHER2-negative breast cancer\n* Previous treatment for breast cancer with an aromatase inhibitor, with or without a CDK4\u002F6 inhibitor, for early breast cancer prior to the current adjuvant treatment line","99 Years",{"count":242,"type":20},319,"OBSERVATIONAL","Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+\u002FHER2-). Despite advancements in adjuvant endocrine therapy, 20-30% of early-stage breast cancer patients relapse within the first decade post-surgery. A recent clinically meaningful therapeutic option for these patients has been cyclin-dependent kinases 4\u002F6 inhibitors (CDK4\u002F6 inhibitors). Abemaciclib and ribociclib were assessed in the adjuvant setting, both showing improvement in invasive disease-free survival (IDFS). Abemaciclib has been approved by the FDA and EMA for HR+\u002FHER2- early breast cancer at high risk of disease recurrence and is the first addition to the Slovenian treatment regimen in routine clinical practice.\n\nPoor medication adherence can directly affect the effectiveness of treatment for early HR+\u002FHER2- breast cancer. While adherence data in patients treated with aromatase inhibitors are available, the adherence rate in patients with early HR+\u002FHER2- breast cancer taking abemaciclib remains unclear.\n\nIn this study, investigators hypothesize that patients receiving abemaciclib in combination with aromatase inhibitors will have lower medication adherence and higher discontinuation rates compared to those receiving aromatase inhibitors alone. It is expected that patients with better quality of life, better cognitive functioning, and a more positive attitude toward their therapy will demonstrate higher medication adherence rates. Adherence may also be influenced by additional factors, such as age and prior treatments.",[246,33,93],"Early Breast Cancer",[248,249,250,251,252,253,254,255],"breast cancer","medication adherence","CDK4\u002F6","HR+","HER2-","aromatase inhibitor","quality of life","medication belief","2026-03-04",{"date":258,"type":39},"2026-03-06",{"date":260,"type":39},"2025-01-05",{"date":262,"type":20},"2027-03-01",{"name":264,"class":106},"Institute of Oncology Ljubljana",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":179,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":275,"conditions":276,"keywords":277,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":4},"100610457","a-ph-ii-study-of-the-therabionic-p1-device-in-subjects-with-hormone-positive-breast-cancer-100610457","NCT07227831","A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer","A Phase 2 Study of TheraBionic P1 Device for Patients With Metastatic Hormone Positive Breast Cancer Post Endocrine Therapy","Inclusion Criteria:\n\n* Participant must have locally advanced\u002Funresectable or metastatic Hormone Receptor (HR) positive, Human Epidermal growth factor receptor 2 (HER2) negative breast cancer as defined by the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (estrogen receptor \\[ER\\] and\u002For progesterone receptor \\[PR\\] \\>1% and HER2 negative by immunohistochemistry \\[IHC\\] and\u002For fluorescent in situ hybridization \\[FISH\\]).\n* Participant must have received and progressed on or are intolerant to all therapies known to confer overall survival benefit, including at least one line of endocrine + CDK4\u002F6 inhibitor therapy AND one line of cytotoxic such as chemotherapy and\u002For antibody drug conjugates (ADCs).\n* Participant must be a woman ≥ 22 years old and must be able to understand and sign an informed consent form.\n* Participant must have a life expectancy of at least 3 months.\n* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.\n* it is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, women of childbearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session.\n* Participants must meet one of the following:\n\n  * Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)\n  * Post-menopausal, defined as no menses for at least 12 months prior to the screening visit without alternative medical causation.\n  * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence methods such as calendar, ovulation, symptothermal, or post ovulation tracking are not acceptable.\n  * Not in a sexual relationship in which they may become pregnant (i.e. same-sex relationship)\n  * If they are of childbearing potential, agree to use at least one method of contraception. Withdrawal is not an acceptable contraceptive method.\n\nExclusion Criteria:\n\n* Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints\n* Participants that are taking any other investigational drugs.\n* Participants that are pregnant or breastfeeding. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued.\n* Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).\n* Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid\u002Fvitamin C, etc.) unless their medical treatment is discontinued at least one day prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study.\n* Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device.",{"count":273,"type":20},82,[183],"The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. The main questions it aims to answer are:\n\n* will the TheraBionic P1 device affect progression free and overall survival in advanced or metastatic HR positive, HER2 negative breast cancer\n* the long term safety and tolerability of the TheraBionic P1 device\n* assessment of how the disease responded to the TheraBionic P1 device",[93,33,31,62],[278],"therabionic","NOT_YET_RECRUITING","2025-11-12",{"date":282,"type":39},"2025-11-13",{"date":284,"type":20},"2026-02",{"date":286,"type":20},"2028-05-22",{"name":196,"class":106},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":81,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":21,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":107},"100484902","phase-2-snf-platform-study-of-hr-her2-advanced-breast-cancer-100484902","NCT05594095","SNF Platform Study of HR+\u002F HER2-advanced Breast Cancer","Precision Platform Study of HR+\u002F HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study)","Inclusion Criteria:\n\n1. Female aged ≥18 years;\n2. HR+\u002FHER2- invasive breast cancer confirmed by histology (specific definition: ER \\>10% positive tumor cells by immunohistochemistry is defined as ER positive, PR \\>10% positive tumor cells is defined as PR positive, ER and\u002For PR positive is defined as HR positive; HER2 0-1+ or HER2 + but negative by FISH without amplification was defined as HER2 negative);\n3. Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;\n4. HR+\u002FHER2- advanced breast cancer patients who had previously received CDK4\u002F6 inhibitor therapy;\n5. At least one measurable lesion according to RECIST 1.1 (conventional CT scan ≥20 mm, spiral CT scan ≥10 mm, measurable lesion has not received radiotherapy);\n6. The functions of the main organs are basically normal and meet the following conditions:\n\n   I. Blood routine examination criteria shall meet: HB ≥90 g\u002FL (no blood transfusion within 14 days); The ANC acuity 1.5 x 109 \u002F L; PLT acuity 75 x 109 \u002F L; Ii. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n7. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity;\n8. ECOG score ≤2, and life expectancy ≥3 months;\n9. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;\n10. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n1. Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);\n2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);\n3. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;\n4. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;\n5. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;\n6. Pregnant or lactating patients; Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.",{"count":296,"type":20},620,[86],"The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK4\u002F6 inhibitors.",[89,26,33,93,31],"2024-10-02",{"date":302,"type":39},"2024-10-04",{"date":304,"type":39},"2022-12-30",{"date":306,"type":20},"2026-12-01",{"name":105,"class":106}]