[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premenopausal-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premenopausal-breast-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,78,106,137,164],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100514714","phase-2-elacestrant-withwithout-triptorelin-in-premenopausal-women-with-luminal-breast-cancer-100514714",false,"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.","FEMALE","35 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,28,29,30],"Breast Cancer","HER2-negative Breast Cancer","Hormone Receptor Positive Tumor","Premenopausal Breast Cancer","RECRUITING","2026-04-21",{"date":34,"type":35},"2026-04-24","ACTUAL",{"date":37,"type":35},"2023-02-03",{"date":39,"type":21},"2026-12",{"name":41,"class":42},"SOLTI Breast Cancer Research Group","OTHER",15,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100601141","phase-3-optimising-adjuvant-chemotherapy-prescription-in-young-patients-with-hormone-dependent-breast-cancer-using-genomic-tests-100601141","NCT07106632","Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests","Optimal Personalized Treatment of Early Breast Cancer Using Multi-parameter Analysis: Focus on YOUNGer Women","OPTIMA-YOUNG","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent;\n2. . Premenopausal defined by patient that are not post-menopaused\n3. Female\n4. Age ≥ 35 years\n5. Diagnosis of invasive HR-positive (ER≥10% of tumour cells stained positive and any PR expression) HER2-negative (IHC score 0-1+ or 2+ with negative\u002Fnon-amplified ISH) invasive breast cancer; ER and HER2 determination will be assessed according to latest ASCO\u002FCAP or national guidelines;\n6. Breast and axillary surgery completed ≤ 12 weeks from study entry and randomization;\n7. Availability of a Formalin-Fixed Paraffin-Embedded (FFPE) tumour sample from surgery to perform Prosigna® analysis or slides.\n\n   Note: in case of receipt of neoadjuvant endocrine therapy the Prosigna® test must be done on the baseline biopsy. Performing the test on the surgical piece or on on-treatment biopsy is not permitted.\n8. Tumour size and axillary lymph node status. One of the following must apply:\n\n   1. 1-3 lymph nodes involved AND any invasive tumour size.\n   2. node negative (including micrometastases in at least 1 node \\[i.e. deposit \\>0.2-2mm diameter\\]) AND invasive tumour size ≥ 50mm.\n9. Multiple ipsilateral breast cancers are permitted provided that at least one tumour meets the tumour size and axillary lymph node entry criteria, and none meet any of the exclusion criteria.\n10. Bilateral breast cancers are permitted provided the tumour(s) in one breast meets the eligibility criteria and the other, contralateral tumour is not ER negative and\u002For HER2 positive and not clinically significant, defined by both of the following:\n\n    1. The contralateral tumour does not fulfil the tumour size and lymph node eligibility criteria required for trial entry; i.e. the following are not acceptable:\n\n       .i. presence of lymph node macro-metastases; .ii. tumour size ≥50mm when there is no lymph node involvement.\n    2. The treating physician does not consider that the characteristics of the contralateral tumour alone justify consideration of adjuvant chemotherapy.\n11. Fitness to receive adjuvant chemotherapy, as judged by the treating physician;\n12. Short term pre-surgical treatment with endocrine therapy, including in combination with non-cytotoxic agents, is allowed providing that the duration of treatment did not exceed 8 weeks;\n13. Patients affiliated with or a beneficiary of the local social security system, health social security system, or other local regulatory requirements\n14. Patients must agree to use adequate contraception methods for the duration of study treatment and for the duration specified in the SmPC after completing the treatment, unless agreed with the treatment physician the safety of attempt a pregnancy, which could be possible after at least 18 months of endocrine therapy.\n\nNote : patient with extracapsular nodular transgression are eligible. NOTE: If neoadjuvant endocrine therapy was received, the Prosigna® test must be realized on the baseline biopsy. Performing the test on the surgical specimen or on biopsy taken during treatment is not permitted.\n\nNOTE: Re-excision or complementary mastectomy for close\u002Fpositive surgical margins should be postponed after chemotherapy completion, if chemotherapy is given; breast reconstruction is allowed after trial entry.\n\nNOTE: The use of approved adjuvant targeted agents (abemaciclib, ribociclib and olaparib) combined to adjuvant endocrine therapy is allowed according to local practice recommendations and availability.\n\nExclusion Criteria:\n\n* 1\\. Postmenopausal women. Women who fulfil the following criteria at trial entry will be considered postmenopausal:\n\n  1. Age \\>45 and natural amenorrhoea of at least 1 year's duration.\n  2. Bilateral surgical oophorectomy.\n  3. For amenorrhoea not fulfilling the above criteria the diagnosis of postmenopausal status should be supported by hormone measurement: FSH levels must be \\> 25IU\u002FL with low oestradiol (i.e. within the locally defined postmenopausal range), in the event of doubt measured on 2 occasions preferably 4-6 weeks apart. This applies to women who have undergone hysterectomy without bilateral surgical oophorectomy and are age \\\u003C60; those ≥60 may be considered postmenopausal.\n\n     NOTE: Hormonal contraception will suppress FSH and oestradiol levels. In those taking oral contraception, levels will recover rapidly on discontinuation. Depo-Provera injectable contraception lasts many months: all women receiving this agent should be considered premenopausal.\n\n     2\\. Stage IV breast cancer; 3. Start of adjuvant systemic treatment (except for neoadjuvant endocrine therapy for a duration ≤ 8 weeks) before trial entry\\*; 4. Previous diagnosis of malignancy except:\n\n  \u003C!-- -->\n\n  1. Previous ductal carcinoma in situ (DCIS) or pleomorphic lobular carcinoma in situ (LCIS) of the breast managed by local treatment only;\n  2. Previous in situ carcinoma as defined by the International Classification of Diseases for Oncology (ICD-O) including basal cell carcinoma of skin and cervical intraepithelial neoplasia;\n  3. Previous invasive malignancy managed by local treatment only AND disease-free for at least 10 years.\n\n     5\\. Patients enrolled in another therapeutic trial within 30 days of inclusion; 6. Presence of concomitant medical and\u002For psychiatric comorbidities and\u002For social problems that might prevent informed consent, treatment compliance or follow up; 7. Person deprived of their liberty or under protective custody or guardianship.\n\n     8\\. Pregnant women or women who are breast-feeding at inclusion. 9. Patients unwilling or unable to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures because of geographic, familial, social, or psychological reasons.\n\n     \\*Trial entry is dated from of the date the participant signs the consent form or provides remote verbal consent, whichever is earlier.","45 Years",{"count":54,"type":21},3380,[56],"PHASE3","Rationale:\n\nAround 70 to 80% of breast cancers are so-called \"hormone-dependent\" (HR+)\u002FHER2-. For more than 50 years, studies have shown that chemotherapy and optimised hormonal treatments (hormone therapy), including a drug associated with ovarian suppression (OFS), improve survival in patients with these cancers, which are characterised by a high risk of relapse. However, younger patients suffer more side effects than older women, particularly from chemotherapy. This can affect their quality of life and reduce their ability to work.\n\nFor post-menopausal women, genetic tests exist to assess whether chemotherapy is really necessary in addition to hormonal treatment. However, for high-risk premenopausal patients, chemotherapy is still systematically recommended, as no study has proved that it can be safely avoided. Clinical trials based on risk stratification using genetic tests have not been conclusive, but the majority of premenopausal women included had not received optimal hormone treatment. It is possible that the beneficial effect of chemotherapy is partly due to the artificial menopause it induces. Some experts believe that, for patients with a high clinical risk but a low genetic risk, an optimised hormonal treatment (drug + OFS) could suffice, without the need for chemotherapy.\n\nObjectives:\n\nMain objective: The aim of the study is to determine whether the use of a genetic test (Prosigna®) to decide whether or not to administer chemotherapy produces results as good as standard treatment (systematic chemotherapy) in premenopausal women with hormone-dependent (HR+) breast cancer\u002FHER2-, by assessing their risk of cancer recurrence.\n\nThe secondary objectives include verifying whether, in patients with a low Prosigna® score (around 70% of cases), optimised hormonal treatment (including suppression of ovarian function) is as effective as chemotherapy combined with hormonal in treatment preventing cancer recurrence. The study also seeks to compare the efficacy of treatment Prosigna®-guided versus systematic chemotherapy in terms of recurrence and quality of life, as well as economic aspects. Finally, the aim is to understand patients' concerns about the concept of reducing treatment (therapeutic de-escalation) and the way in which this information is communicated to them.\n\nThe primary endpoint of the study is to measure the time elapsed between the start of participation in the study and the appearance of an event indicating a return of the cancer. This includes the return of cancer in the same breast or neighbouring areas, the spread of cancer to other parts of the body, the appearance of new cancer in the other breast or death from any cause.\n\nTrial Population:\n\nThe study includes women major premenopausal diagnosed with invasive, hormone receptor-positive (ER+) and HER2-negative breast cancer. Patients must have undergone breast and axillary surgery recent and have a tumour sample suitable for analysis by the testProsigna® . They must be able to receive the study treatments Postmenopausal women, women with stage IV breast cancer, women who have already received adjuvant systemic treatment (except short neoadjuvant hormone therapy), women with a recent history of invasive cancer, pregnant women or women who are breast-feeding will not be able to take part in the study.\n\nInterventions:\n\nAfter agreeing to take part, patients will enter the pre-inclusion period (up to 28 days before randomisation), during which the investigator will carry out all the necessary tests to assess their eligibility. The investigator will then randomise the patients to find out which treatment they have been assigned, no more than 2 weeks later: the experimental group will receive a treatment decided on the basis of the results of a genomic test: either chemotherapy and hormone therapy, or hormone therapy alone. The control group will receive the standard treatment. The treatment and follow-up phases are the same as for standard care. Information on the quality of life patient's will and other information (associated costs, perception of their participation in the study, etc.) also be collected by means of questionnaires completed by the patients during the 5 years following randomisation.",[59,30,60],"Early Breast Cancer","HR+\u002FHER2- Breast Cancer",[62,63,64,65,66],"Adjuvant therapy de-intensification","Care delivery","Quality of Life","Premenopausal Women","Risk stratification","NOT_YET_RECRUITING","2026-03-23",{"date":70,"type":35},"2026-03-24",{"date":72,"type":21},"2026-04-01",{"date":74,"type":21},"2038-08-15",{"name":76,"class":42},"UNICANCER",105,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":90,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100551336","sexual-dysfunction-check-up-in-premenopausal-breast-cancer-survivors-taking-endocrine-therapy-a-cross-sectional-study-100551336","NCT06458764","Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study","SEXCHECK - Sexual Dysfunction Check-up in Premenopausal Breast Cancer Survivors Taking Endocrine Therapy: A Cross-Sectional Study","SEXCHECK","Inclusion Criteria:\n\n* women aged ≥18 and ≤ 55\n* who underwent surgery for early stage breast cancer\n* taking endocrine therapy for at least 3 months\n* providing an informed consent and completing the study questionnaires.\n\nExclusion Criteria:\n\n* withdrawal of the informed consent, at any time","18 Years","55 Years",{"count":89,"type":21},150,"1 Month","OBSERVATIONAL","Primary objectives:\n\n* To estimate Sexual Dysfunction (SD) incidence in premenopausal breast cancer patients treated by surgery and taking endocrine therapy.\n* To detect the presence of SD-related distress in the population, as a determining factor in the maintenance of a good quality of life.\n\nSecondary objectives:\n\n* To describe SD characteristics determining the most frequently reported symptoms and correlations with type of surgery or therapeutic regimens.\n* Collect baseline data for subsequent randomized trials involving practical interventions with the aim to reduce SD prevalence in this population.",[94,95,30],"Breast Cancer Female","Sexual Dysfunction","2025-06-18",{"date":98,"type":35},"2025-06-24",{"date":100,"type":35},"2023-05-01",{"date":102,"type":21},"2025-12-01",{"name":104,"class":42},"Candiolo Cancer Institute - IRCCS",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100464871","phase-4-ofs-in-premenopausal-node-breast-cancer-with-low-genomic-risk-100464871","NCT05333328","OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk","Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)","INTERSTELLAR","Inclusion Criteria:\n\n* ER+HER2- breast cancer\n* Premenopausal and age \\\u003C=50\n* T1 or T2\n* N1 including micrometastasis\n* Genomic Low Risk by OncoFREE test® (1-20)\n\nExclusion Criteria:\n\n* Postmenopausal women\n* ER-negative breast cancer","20 Years","50 Years",{"count":117,"type":21},418,[119],"PHASE4","Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).\n\nIn these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.",[27,122,28,30,123],"Estrogen Receptor Positive Tumor","Node-positive Breast Cancer",[27,122,28,30,123,125,126],"Multigene assay","Ovarian-function suppression","2025-05-18",{"date":129,"type":35},"2025-05-22",{"date":131,"type":35},"2023-02-06",{"date":133,"type":21},"2033-01",{"name":135,"class":42},"Gangnam Severance Hospital",2,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":105},"100533397","phase-2-neoadjuvant-chemotherapy-with-or-without-gnrh-agonist-for-premenopausal-triple-negative-early-breast-cancer-patients-100533397","NCT06225284","Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients","A Randomized Phase II Study of Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients: ESCALATE Study","ESCALATE","Inclusion Criteria:\n\nPatients eligible for inclusion in this study have to fulfill all of the following criteria:\n\n1. Written informed consent must be obtained before any assessment is performed.\n2. Female patients aged ≥ 18 years at screening; Must be premenopausal according to serum E2, FSH level.\n3. Histological confirmed TNBC, as defined by the most recent ASCO\u002FCAP guidelines. Hormone receptor-low\u002FHER2 negative as defined by ER 1% to \\\u003C10% and\u002For PR 1% to \\\u003C10% on IHC staining; neither hormone receptor may be ≥ 10%; and HER2-negative (IHC 0+\u002F1+, or IHC 2+ plus FISH negative) is allowed.\n4. Have previously untreated locally advanced non-metastatic (M0) TNBC and hormone receptor-low\u002FHER2-negative defined as the following combined primary tumor (T) and regional lymph node (N) staging per current AJCC staging criteria for breast cancer staging criteria as assessed by the investigator based on radiological and\u002For clinical assessment: T1c, N0-N2; or T2, N0-N2; or T3, N0-N2; or T4a-d, N0-N2.\n5. Agree to receive core needle biopsy for translational research.\n6. ECOG 0-1.\n7. Patients must have adequate organ and marrow reserve measured within 14 days prior to randomization as defined below:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL;\n   * Absolute neutrophil count ≥ 1,500 \u002FμL;\n   * Platelets ≥ 100,000\u002FμL;\n   * Total bilirubin ≤1.5 x upper normal limit;\n   * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x upper normal limit;\n   * Serum creatinine ≤ 1.5mg\u002FdL or creatinine clearance ≧50ml\u002Fmin;\n   * aPTT \\\u003C 1.5 x upper normal limit (unless on therapeutic anti-coagulation);\n8. Plan to receive breast cancer surgery.\n9. Must have a negative pregnancy test obtained within 3 days before starting therapy. Patients must not be breastfeeding.\n10. Patients must use effective contraception prior to study entry and for the duration of study participation, and for 6 months after the completion of therapy.\n11. Patients (or a surrogate) must be able to comply with study procedures and to give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol (CSP). The patients (or a surrogate) must be able to provide of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.\n\nExclusion criteria Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the Investigator, in order to ensure that the study population will be representative of all eligible patients.\n\n1. Patients have received any prior therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or hormone therapy) for breast cancer.\n2. Evidence of systemic metastasis.\n3. Pregnancy or lactation.\n4. Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n5. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs, with exception of hydroxychloroquine (Plaquenil®)) in subjects planning for pembrolizumab use.\n6. Has a diagnosis of immunodeficiency or is receiving high dose of systemic steroid therapy. Patients with minor medical disease condition (i.e. mild asthma) requiring prednisolone equal to or less than 20 mg\u002Fday or the equivalent may be allowed.\n7. Has an active systemic bacterial, viral or fungal infection requiring systemic therapy.\n8. Psychiatric illness or social situation that would preclude study compliance.\n9. Serious non-healing wound, ulcer, or bone fracture. Except for breast cancer related non-healing wound or ulcer.\n10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrolment.\n11. History of allergic reaction to compounds of similar chemical composition to the study drugs.\n12. Any of the following conditions or treatments that may impact the safety of the patient:\n\n    * History of, or current, significant cardiac disease including cardiac failure (NYHA functional class II-IV), myocardial infarction (within 6 months), unstable angina (within 6 months), transient ischemic attack (within 6 months), stroke, cardiac arrhythmias requiring treatment or uncontrolled arterial hypertension\n    * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker on screening electrocardiogram (ECG)\n    * History of or active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis\n    * Severe hepatic impairment (Child-Pugh class C)\n    * Any medically unstable condition as determined by the Investigator\n13. Patients unable or unwilling to undergo serial breast tumor biopsy.\n14. History of hypersensitivity to any of the study drugs.",{"count":146,"type":21},124,[24],"Breast cancer (BC), especially premenopausal, is emerging rapidly in East Asia in recent 20 years. Half of the breast cancer patients in Asia are younger than 50 years of age. In general, younger or premenopausal patients are associated with poorer prognosis.\n\nPremenopausal patients have higher estrogen levels than those in older (postmenopausal) patients. Estrogen is known to suppress anti-tumor T cell response and leading to tumor progression in different animal models (Clin Cancer Res 2016 22:6204), including lung cancer, melanoma, ovarian cancer. One of the mechanisms that contributes to estrogen's suppression of T cell function is via the mobilization of myeloid-derived suppressor cells (MDSC). Targeting ER signaling with hormonal therapy can abolish MDSC mobilization, and sensitize tumor cells to antigen specific T cell or NK cell killing (Cancer Discovery 2018 7:72 2017). These study results further support the hypothesis that, E2 is associated with immunosuppressive effect, and may contribute to the suppression of immune surveillance in young female breast cancer patients. These results suggest that E2 may suppress anti-tumor immunity, and E2 reduction improve the anti-tumor immunity. In our preliminary works, the investigators found higher dose (equivalent to premenopausal women serum level) of E2 suppressed T cell activities, while lower dose E2 (postmenopausal serum level) activated T cell activity. The investigators have investigated the combination of anti-PD1 antibody and GnRH agonist plus exemestane (an aromatase inhibitor which will block the production of E2 from adipose tissue) in ER positive premenopausal breast cancer patient refractory to prior endocrine therapy in metastatic setting. The response rate was 38.4%, and median progression-free survival (PFS) was 10.2 months. This outstanding result were presented in AACR 2021 oral session (Cancer Res 2021 81:13\\_Supplement, CT028). On the other hand, progesterone is also well known for its anti-inflammation and immune tolerance activity. This possibly makes estrogen reduction treatments, such as gonadotropin-releasing hormone agonist (GnRH agonist), an important partner in augmenting neoadjuvant therapy for patients with premenopausal breast cancer.\n\nFor triple negative breast cancer (TNBC), endocrine therapy has no anti-tumor effect. On the other hand, the use of GnRH agonist has been tested for the protection of ovary function of young female while receiving adjuvant chemotherapy. Surprisingly, the concomitant use of goserelin and adjuvant chemotherapy improved disease-free survival (HR 0.47, P=0.04) and overall survival (HR 0.45, P=0.05) versus chemotherapy alone in ER negative premenopausal early BC patients in POEMS study, which was initially aimed to improve the success pregnant rate (N Engl J Med 2015 372;923). Endocrine therapy is theoretically antagonist to chemotherapy therapy when concomitantly use. In another report analyzed the outcome of both pre- and postmenopausal women who entered two randomized trials (Gruppo Oncologico Nord-Ovest-Mammella Intergruppo studies) on adjuvant chemotherapy and received either concomitant or sequential hormonal therapy. The result showed a decreasing trend (P = 0.015) in hazard ratio of death with increasing age was observed, indicating that concomitant therapy is more effective than sequential therapy in young patients (Annals of Oncology 2008;19(2):299-307). These results support the hypothesis that, E2 suppression\u002FER inhibition therapy may modulate immune microenvironment, thereby enhancing the chemotherapy induced immunogenic death effect.\n\nThe investigators hypothesized that, estrogen level reduction by ovarian function suppression can modulate immune microenvironment, thereby augmenting adjuvant chemotherapy efficacy, regardless of the estrogen receptor (ER) status of cancer cell. Therefore, the investigators plan to test this hypothesis in real clinical model, with standard clinical recommended treatment doses.\n\nThe study is designed to evaluate whether the GnRH agonist can provide the therapeutic benefit for premenopausal TNBC patients via modulating immune microenvironment. Premenopausal TNBC patients will receive GnRH agonist and neoadjuvant chemotherapy, and the efficacy and immune microenvironment change of co-administration arm will be measured and compared with chemotherapy alone control arm.",[150,30],"Triple Negative Breast Cancer",[152,153,154,30],"Neoadjuvant chemotherapy","Triple negative breast cancer","Gonadotropin Releasing Hormone Agonist","2025-04-25",{"date":157,"type":35},"2025-04-29",{"date":159,"type":35},"2024-08-22",{"date":161,"type":21},"2030-12",{"name":163,"class":42},"National Taiwan University Hospital",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":105},"100494598","phase-2-immunotherapy-hormone-therapy-and-akt-inhibitor-for-premenopausal-er-positive-mbc-100494598","NCT05720260","Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC","A Randomized, Phase II Study for Premenopausal Metastatic or Locally Advanced Breast Cancer Patients: Capivasertib, Goserelin, Fulvestrant With\u002FWithout Durvalumab, Versus Goserelin, Fulvestrant, and Durvalumab, Versus Goserelin\u002F Fulvestrant.","Inclusion criteria\n\n1. A histological confirmed ER positive (\\>1%) invasive breast cancer.\n2. Locally advanced or metastatic disease with at least one measurable target lesion\n3. Patients who had not received chemotherapy for locally advanced or metastatic disease\n4. Patients have to be (i) either primary resistant to hormonal therapy defined as recurrence developed within 2 years of adjuvant hormonal therapy (ii) or resistant to prior hormonal therapy (failed ≤ 2lines of hormonal therapy for locally advanced or metastatic breast cancer)\n5. Patients must be premenopausal or perimenopausal women according the clinical menstrual history or E2 \u002F FSH level based on local hospital guidance. Patient with menopausal status cannot be determined due to ongoing LHRH agonist treatment is allowed if evidence of premenopausal status prior to patients' LHRH agonist usage can be provided.\n6. ECOG 0-1\n7. Patients must have adequate organ and marrow reserve measured within 14 days(within screening period ) prior to randomization as defined below:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL;\n   * Absolute neutrophil count ≥ 1,500 \u002FL;\n   * Platelets ≥ 100,000\u002FL;\n   * Total bilirubin ≤ 1.5 x upper normal limit;\n   * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)\u002FALT(SGPT) ≤ 5 x upper normal limit is allowed;\n   * Serum creatinine ≤ 1.5mg\u002FdL or creatinine clearance ≧50ml\u002Fmin;\n   * aPTT \\\u003C 1.5 x upper normal limit (unless on therapeutic anti-coagulation);\n   * Proteinuria ≤ 1+ with urine dipstick, if \\> 1+, 24-hour urine protein must be ≤ 1 g.\n8. Age older than 20-year-old.\n9. All women of childbearing potential must have a negative pregnancy test obtained within 7 days before starting therapy. Patients must not be breastfeeding.\n10. Patients with reproductive potential must use effective contraception (hormone or barrier method of birth control) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy.\n11. Patients (or a surrogate) must be able to comply with study procedures and to give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol (CSP). The patients (or a surrogate) must be able to provide of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.\n12. Body weight \\>30 kg\n13. Must have a life expectancy of at least 12 weeks Exclusion criteria\n\nPatients fulfilled ANY of the following criteria will be excluded from this trial:\n\n1. Prior therapy with capivasertib, fulvestrant, anti-PD1 or anti-PDL1 immunotherapy\n2. Prior chemotherapy for locally advanced or metastatic breast cancer.\n3. Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment\n4. The tumor is HER-2 positive by IHC 3+ or IHC 2+\u002FISH positive.\n5. Patients have active brain metastases or spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment\n6. Other malignancy within 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.\n7. Psychiatric illness or social situation that would preclude study compliance.\n8. Serious non-healing wound, ulcer, or bone fracture.\n9. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.\n10. Prior minor surgery within 7 days.\n11. History of allergic reaction to compounds of similar chemical composition to the study drugs.\n12. Pregnancy or lactation.\n13. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment\n14. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n15. Known to have tested positive for human immunodeficiency virus\n16. History of allogenic organ transplantation.\n17. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion: a) Patients with vitiligo or alopecia; b) Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; c)Any chronic skin condition that does not require systemic therapy; d) Patients without active disease in the last 5 years may be included but only after consultation with the study physician; e)Patients with celiac disease controlled by diet alone.\n18. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib.\n19. History of another primary malignancy except for: a) Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence; b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c)Adequately treated carcinoma in situ without evidence of disease\n20. History of leptomeningeal carcinomatosis.\n21. Previous allogeneic bone marrow transplant or solid organ transplant.\n22. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed \\\u003C\\\u003C10 mg\u002Fday\\>\\> of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n23. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n24. Any of the following cardiac criteria at screening:\n\n    * Mean resting corrected QT interval (QTc) \\>470 msec obtained from 3 consecutive ECGs\n    * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block)\n    * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval\n    * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥2\n    * Uncontrolled hypotension - SBP \\\u003C90 mmHg and\u002For DBP \\\u003C50 mmHg\n    * Cardiac ejection fraction outside institutional range of normal or \\\u003C50% (whichever is higher) as measured by echocardiogram.\n25. Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening:\n\n    * Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment\n    * HbA1c ≥8.0% (63.9 mmol\u002Fmol)\n26. Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment\n27. Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4, CYP2C9 and\u002For CYP2D6 with a narrow therapeutic window within 1 week prior to the first dose of study treatment.\n28. Participation in another clinical study with an investigational medicinal product (IMP) administered in the last 30 days or 5 half-lives, whichever is longer\n29. History of hypersensitivity to active or inactive excipients of capivasertib, fulvestrant, durvalumab, goserelin or drugs with a similar chemical structure or class to the above-mentioned drugs\n30. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.",{"count":172,"type":21},42,[24],"This is an open-label randomized phase II study in estrogen receptor positive locally advanced or metastatic breast cancer patients. The main inclusion population are either luminal subtype B by PAM50 analysis or failed less than 2 lines of hormonal therapy for locally advanced or metastatic breast cancer. The subjects have to be premenopausal or perimenopausal and are not allowed to receive any systemic chemotherapy for their locally advanced or metastatic breast cancer. Eligible subjects will be randomized into goserelin\u002F fulvestrant\u002F durvalumab (Arm A), goserelin\u002F fulvestrant\u002F capivasertib\u002F durvalumab (Arm B), or goserelin\u002F fulvestrant\u002F capivasertib (Arm C) at a 1:1:1 ratio. The primary endpoint is objective response rate (ORR) of the whole other three arm compared to historical goserelin\u002F fulvestrantcontrol arm. The major secondary endpoint will be progression-free survival or ORR compared among different treatment arms.",[30,176,177],"Metastatic Breast Cancer","ER Positive Breast Cancer","2024-06-07",{"date":180,"type":35},"2024-06-10",{"date":182,"type":35},"2023-01-17",{"date":184,"type":21},"2027-01-31",{"name":163,"class":42}]