[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-low-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-low-breast-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,74,149,173],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100608220","phase-1-eradicate-a-phase-ibii-study-of-elacestrant-plus-trastuzumab-deruxtecan-in-patients-with-cdk46-inhibitor-and-endocrine-resistant-hrher2-low-or-her2-ultralow-metastatic-breast-cancer-100608220",false,"NCT07198724","ERADICATE: A Phase Ib\u002FII Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4\u002F6 Inhibitor and Endocrine-resistant HR+\u002FHER2-low or HER2-ultralow Metastatic Breast Cancer","ERADICATE","Inclusion Criteria:\n\n* Participants must have a histologically or cytologically confirmed diagnosis of HR+\u002FHER2-low metastatic or unresectable locally advanced breast cancer, defined as ER ≥ 10%, any PR in the most recent sample and HER2-low (IHC 1+ or IHC 2+ and ISH non-amplified) or HER2-ultralow (IHC 0 and any membranous staining on any prior primary or metastatic sample). Cutoff values for positive\u002Fnegative HER2 staining should be in accordance with current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines.76\n* Participants must have had prior CDK4\u002F6 inhibitor and may have any number of prior endocrine based therapies in the metastatic setting.\n* Participants may have progressed on up to 1 prior line of prior chemotherapy or ADC in the metastatic setting.\n* Participants must have measurable disease per RECIST 1.1 criteria. See Section 11 for the definition of measurable disease. Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.\n* Participants must have known ESR1 mutation status in tumor or ctDNA within 6 months of enrollment to the trial. Participants must have Guardant360 CDx testing for ESR1-mutation status if status has not been validated within 60 days of registration.\n* Women or men age ≥18 years are eligible.\n* ECOG performance status ≤ 2.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FµL\n  * Platelets ≥ 100,000\u002FµL\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 2 x ULN in patients with documented Gilbert's syndrome)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x institutional ULN (or \\\u003C 5 x ULN in patients with liver metastases)\n  * Creatinine ≤ 1.5 x institutional ULN OR\n  * Calculated creatinine clearance ≥ 45 mL\u002Fmin via the Cockcroft-Gault formula for participants with creatinine levels above institutional ULN\n  * Baseline LVEF ≥ 50% prior to registration, as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n  * Participants with a history of central nervous system (CNS) metastases are eligible if: Stable or untreated, asymptomatic brain metastases not needing immediate local therapy. For patients with untreated CNS lesions \\> 2.0 cm on screening contrast brain MRI, discussion with and approval from the Sponsor Investigator is required prior to enrollment.\n\n    1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator\n    2. Patients treated with CNS local therapy for newly identified lesions may be eligible to enroll if all of the following criteria are met: Time since WBRT is ≥ 14 days prior to first dose of treatment, time since SRS is ≥ 7 days prior to first dose of treatment, and time since surgical resection is ≥ 14 days\n* Postmenopausal women must be postmenopausal, which is defined as any of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH, and estradiol in the postmenopausal range per local normal range\n  * Premenopausal women made postmenopausal through the use GnRH agonist prior to study entry are eligible and MUST remain on the GnRH agonist for the duration of protocol treatment.\n  * Status-post bilateral oophorectomy - After adequate healing post-surgery\n* Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are postmenopausal according to the definition in 3.1.10.\n* Women of child-bearing potential and men must agree to use adequate contraception at time of enrollment and for 4 months after the last dose of elacestrant or 7 months after the last dose of trastuzumab deruxtecan, whichever is later.\n* Participants must be able to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment with aatopoisomerase inhibitor antibody drug conjugate in any setting.\n* Prior treatment with an oral novel estrogen receptor degrader or modulator in the metastatic setting (SERD, SERM, PROTAC, or CERAN). Prior fulvestrant is allowed. A washout period of 7 days is required for any endocrine or targeted therapy. A washout period of 14 days is required for any chemotherapy.\n* Patients with known brain metastases that are symptomatic or that require therapy for symptom control are not eligible. Patients with stable or asymptomatic brain metastases are allowed. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 4 weeks before day 1 of study therapy will be excluded.\n* Receipt of any other investigational compound or device within 2 weeks of the first dose of treatment in this study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant or T-DXd.\n* History of (non-infectious) pneumonitis that required steroids or current ILD by imaging at screening.\n* Patients who are pregnant or breastfeeding, or who expect to become pregnant within the projected duration of the study.\n* Patients with active tuberculosis.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, uncontrolled diabetes mellitus, gastrointestinal disorders potentially affecting the absorption of elacestrant, inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or total gastric resection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Moderate or severe hepatic impairment (Child-Pugh B or C). Active hepatitis B or active hepatitis C infection. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation. History of myocardial infarction, acute coronary syndrome or coronary angioplasty\u002Fstenting\u002Fbypass grafting within the last six months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.\n* Patients with a history of different malignancy are ineligible, except for those who have been disease-free for at least three years and are deemed by the investigator to be at low risk for recurrence of the prior malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.","ALL","18 Years",{"count":19,"type":20},65,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4\u002F6 inhibitor and endocrine therapy.\n\nThe names of the study drugs involved in this study are:\n\n* Elacestrant (a type of selective estrogen receptor degrader)\n* Trastuzumab deruxtecan (a type of standard of care antibody drug conjugate)",[27,28,29,30,31],"Metastatic Breast Cancer","HER2 Low Breast Carcinoma","HER2-negative Breast Cancer","Breast Cancer","Breast Cancer Female",[27,28,29,30,31,33,34,35],"HR+\u002FHER2-low Breast Cancer","HR+\u002FHER2-ultralow Breast Cancer","Endocrine-resistant Breast Cancer","RECRUITING","2026-06-08",{"date":39,"type":40},"2026-06-10","ACTUAL",{"date":42,"type":40},"2025-11-17",{"date":44,"type":20},"2038-06-01",{"name":46,"class":47},"Kristina A. Fanucci","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":48},"100533350","phase-2-arx788-for-treating-patients-with-her2-low-locally-advanced-unresectable-or-metastatic-breast-cancer-100533350","NCT06224673","ARX788 for Treating Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer","Phase II Open-label Study of ARX788 (Anti-HER2 Antibody Drug Conjugate (ADC)) for Patients With HER2-low Locally Advanced Unresectable or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Male or female participants age 18 years or greater with ability to provide written informed consent for the study.\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2.\n* Estimated life expectancy of at least at 6 months per investigator assessment.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Pathologically documented HER2-low locally advanced unresectable or metastatic breast cancer (MBC). NOTE: human epidermal growth factor receptor 2 (HER2)-low status determined by HER2 immunohistochemistry (IHC) 1+ or 2+ and no evidence of HER2 gene amplification by in situ hybridization (ISH)\u002Ffluorescence in situ hybridization (FISH), which can be documented from any tumor sample during the patient's cancer treatment history (early-stage or metastatic).\n\n  * Cohort 1: Participants with hormone receptor positive (HR+)\u002FHER2-low locally advanced unresectable or MBC. HR+ status defined as estrogen receptor \\>= 10% and\u002For progesterone receptor ≥ 10% and HER2 low.\n  * Cohort 2: Participants with hormone receptor negative (HR-)\u002FHER2-low locally advanced unresectable or MBC. Considered HR- if estrogen receptor (ER) and progesterone receptor (PR) \\\u003C 10% and HER2-low.\n* Presence of at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. NOTE: Participant's with at least one measurable lytic bone lesion are eligible.\n* Availability of tumor block or formalin-fixed paraffin-embedded (FFPE) tissue as 10 precut unstained slides will be collected for the HER2 status evaluation and biomarker analysis based on the most recent tumor tissue sample. NOTE: New pretreatment biopsy tissue is preferred as HER2 status may change, but a fresh biopsy is not required. The study team and investigator will make every attempt to get archival tissue. Participants who do not have archival or new tumor tissue available may be eligible after discussion with the study principal investigator (PI).\n* Participants with stable and treated brain metastases are eligible if the participants meet the following criteria:\n\n  * Prior stereotactic radiosurgery (SRS) should be completed \\>=7 days before study treatment initiation.\n  * Prior whole-brain radiation therapy should be completed \\>=14 days before study treatment initiation.\n  * Any ongoing use of systemic corticosteroids does not exceed 2 mg of dexamethasone (or equivalent) daily.\n* Participants must have received at least one prior line of chemotherapy or ADC therapy for locally advanced unresectable or metastatic disease. Prior checkpoint inhibitor therapy is allowed.\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL\n* Platelets ≥ 100,000 x 10\\^9\u002FL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) \\\u003C 3 x institutional upper limit of normal. In participants with liver metastases, \\\u003C= 5 x institutional upper limit of normal is allowed.\n* Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)) \\\u003C 3 x institutional upper limit of normal. In participants with liver metastases, \\\u003C=5 x institutional upper limit of normal is allowed.\n* Creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m, calculated using the Cockcroft-Gault equation\n* Adequate cardiac function as assessed by left ventricular ejection fraction ≥ 50% or institutional lower limit of normal.\n* Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy.\n* Individuals with a history of hepatitis C virus (HCV) infection must have been treated without detectable HCV RNA.\n* Participants must have recovered from all acute toxicities from prior therapies to ≤ grade 1 or baseline (except for alopecia and neuropathy) per the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.\n* Male and female subjects of reproductive\u002Fchildbearing potential must agree to use a highly effective form of contraception or total sexual abstinence during and upon completion of the study; and for at least 3 months after the last dose of study drug for women of childbearing potential (WOCBP) and at least 5 months after the last dose of study drug for men whose partners are WOCBP.\n* Male subjects must agree to not freeze or donate sperm starting at Screening and throughout the study period, and at least 5 months after the final study drug administration.\n* Female subjects must agree to not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 3 months after the final study drug administration.\n\nExclusion Criteria:\n\n* Has a prior history of treatment with ARX-788 or auristatin analogues.\n* Has a history of allergic reaction to any component of ARX788.\n* Has exposure to any other investigational or commercial anti-cancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of study treatment. NOTE: Anti-hormonal therapy may be administered up to 7 days prior to the first dose of study treatment.\n* Radiotherapy outside of the brain administered \\\u003C7 days prior to first dose of ARX788\n* Prior or current history of interstitial lung disease (ILD), pneumonitis, or other clinically significant lung disease with the exception of disease that is directly attributable to the presence of lung metastases from their underlying cancer.\n* Participants with significant pulmonary conditions, defined as any of the following:\n\n  * Any prior history of drug-induced immune-mediated pneumonitis.\n  * Prior history of radiation therapy to the chest of \\> 18 gray (Gy) with residual sequelae considered clinically significant by investigator assessment.\n  * Radiographic evidence of radiation fibrosis involving \\> 15% of the lung parenchyma associated with clinical symptoms.\n  * Any requirement for supplemental oxygen.\n* Clinically-significant ocular findings including history of keratitis, keratopathy, and\u002For active eye disease (excluding glaucoma).\n* History of congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment. QTcF prolongation of \\>470 msec (females) or \\>450 msec (males) based screening ECG.\n* Has a diagnosis of leptomeningeal carcinomatosis. NOTE: Stable brain metastases are allowed.\n* Has an active systemic or psychiatric illness that would impact the patient's ability to receive study therapy.\n* Has an uncontrollable intercurrent illness, infection (including participants with active, symptomatic Coronavirus disease of 2019 (COVID-19) infections), or other conditions that could limit study compliance or interfere with study assessments.\n* Has a history of an additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ (excluding carcinoma in situ of the bladder or high-grade cervical dysplasia in the last three years), and thyroid cancer not requiring cytotoxic agents that have undergone potentially curative therapy are not excluded.\n* Pregnancy or breastfeeding.\n* Has an active, uncontrolled hepatitis B, hepatitis C, and\u002For human immunodeficiency virus (HIV) infection. Participants with adequately controlled hepatitis B, hepatitis C, and\u002For HIV are allowed. NOTE: HIV and hepatitis B and C testing are not required for screening. Testing will only be done if clinically indicated.",{"count":57,"type":20},36,[24],"This phase II trial tests how well ARX788 works in treating patients diagnosed with HER2-low, locally advanced unresectable or metastatic breast cancer. ARX788 is an antibody-drug conjugate (ADC) that is given by infusion (diluted and injected slowly into veins). Antibodies are proteins which are naturally produced by the body's immune system to help fight infections. ARX788 consists of antibodies that have been attached to a toxin that has the potential to kill cancer cells. ARX788 sticks to a protein called human epidermal growth factor receptor (HER2), which is found on some breast cancer cells. Giving ARX788 may be safe and effective in treating patients with HER2-low locally advanced unresectable metastatic breast cancer.",[28,61,62,63],"Triple Negative Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma",[65],"Antibody-drug Conjugate",{"date":67,"type":40},"2026-06-11",{"date":69,"type":40},"2026-06-05",{"date":71,"type":20},"2029-11-30",{"name":73,"class":47},"Laura Huppert, MD, BA",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":104,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100505964","phase-1-pre-i-spy-phase-iib-oncology-platform-program-100505964","NCT05868226","PRE-I-SPY Phase I\u002FIb Oncology Platform Program","PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I\u002FIb Platform Trial","PRE-I-SPY-PI","General Inclusion Criteria (GIC):\n\n* GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).\n* GIC2: Age ≥ 18 years at the time of signing the informed consent\n* GIC3: Gender: Male or female (premenopausal and postmenopausal)\n* GIC4: ECOG performance status Grade 0-2\n* GIC5: Estimated life expectancy \\> 12 weeks at the start of investigational medicinal product (IMP) treatment.\n* GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for small molecules and \\>30 mL\u002Fmin for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility.\n\nThese cut-off values may be modified with supporting data for specific drug regimens.\n\n* GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.\n* GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom \u002F occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository).\n* GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.\n* GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Additional arm specific inclusion criteria as needed by drug arm regimen\n\nGeneral Exclusion Criteria (GEC):\n\n* GEC1: Wash out periods: No other anticancer therapy within the following periods:\n\n  * chemotherapy or investigational agents, 3 weeks\n  * mitomycin C and nitrosoureas, 6 weeks\n  * radiotherapy, 3 weeks\n  * targeted therapy, 2 weeks\n  * MAbs, ADCs, and immunotherapy, 3 weeks\n  * endocrine therapy, no washout needed\n* GEC2: Concurrent therapy with other Investigational Products.\n* GEC3: Prior history of drug\u002Fregimen hypersensitivity: History of infusion-related reactions and\u002For hypersensitivity to IMP or excipients of the study drug\u002Fdrugs which led to permanent discontinuation of the treatment.\n* GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \\> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.\n* GEC6: CNS tumoral spread: Active uncontrolled\u002Fsymptomatic central nervous system cancer\u002Fspinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.\n* GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.\n* GEC8: Recent major surgery within 4 weeks prior to start IMP treatment\n* GEC9: Pregnancy or breastfeeding\n* GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n* GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.\n* Additional arm specific exclusion criteria as needed by drug arm regimen",{"count":83,"type":20},124,[23],"I-SPY Phase I\u002FIb (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and\u002For other oncology-based trials in a timely manner.",[87,88,27,89,90,91,92,29,61,93,94,95,96,97,98,99,100,101,28,102,103],"HER2-positive Breast Cancer","Metastatic Cancer","Metastatic","HER2-positive Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER-2 Protein Overexpression","HR Positive","Hormone Receptor-positive Breast Cancer","Estrogen Receptor Positive Tumor","Progesterone Receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma","Solid Tumor","Solid Tumor, Adult","Solid Carcinoma","HER2 Low Breast Cancer","ER Positive Breast Cancer","PR-positive Breast Cancer",[105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138],"I-SPY Trials","Quantum Leap Healthcare Collaborative","QLHC","I-SPY","I-SPY2","I-SPY1","PRE-ISPY","PRE-I-SPY","I-SPY Phase 1","I-SPY Phase 1b","I-SPY-P1","ISPY","ISPYP1","I-SPY Phase 1 Platform","ISPY2","ISPY1","Phase 1 Platform","Phase 1 Oncology Platform","T-DXd naive","PRE1","PRE2","PRE3","PRE","PRE-I-SPY Phase 1","PRE-I-SPY Phase 1b","ALX148","T-DXd","Enhertu","Zanidatamab","Tucatinib","Ziihera","Tukysa","Evorpacept","QL","2025-04-01",{"date":141,"type":40},"2025-04-04",{"date":143,"type":40},"2023-02-15",{"date":145,"type":20},"2029-12-30",{"name":147,"class":47},"QuantumLeap Healthcare Collaborative",7,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":156,"minAge":17,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":48},"100509325","phase-2-a-study-of-shr-a1811-as-neoadjuvant-treatment-for-patients-with-hr-positive-low-her2-expression-breast-cancer-100509325","NCT05911958","A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer","Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer","Inclusion Criteria:\n\n1. Patients aged 18 to 70 years old (inclusive);\n2. Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;\n3. HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;\n4. ECOG performance status of 0-1;\n5. Normal organ and bone marrow function;\n6. Patients of childbearing age must consent to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding;\n7. Patients voluntarily joined the study and signed informed consent;\n\nExclusion Criteria:\n\n1. Patients have evidence of metastatic breast cancer, or inflammatory breast cancer;\n2. Patients previously received antineoplastic therapy or radiotherapy for any malignancy, excluding cured malignancies such as cervical carcinoma in situ, basal cell carcinoma, or squamous carcinoma;\n3. Patients received any other anti-tumor therapy at the same time, including endocrine therapy, bisphosphonates or immunotherapy;\n4. Patients have major surgical procedures unrelated to breast cancer within 4 weeks before the first medication, or not fully recovered from surgical procedures;\n5. Clinically significant pulmonary or cardiovascular disease;\n6. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption;\n7. Known to be allergic to any study drug or any of its excipients;\n8. History of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n9. Pregnant and lactating women;\n10. Patients with serious concomitant diseases or other comorbidities that will interfere with the planned treatment, or any other condition that is not suitable for participation assessed by investigator.","FEMALE","70 Years",{"count":159,"type":20},66,[24],"HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.",[28],"2024-10-31",{"date":165,"type":40},"2024-11-04",{"date":167,"type":40},"2023-07-05",{"date":169,"type":20},"2029-05-31",{"name":171,"class":172},"Henan Cancer Hospital","OTHER_GOV",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":48},"100538995","phase-1-dose-expansion-modular-study-to-explore-the-safety-tolerability-and-anti-tumor-activity-of-her3--dxd-monotherapy-and-combinations-in-patients-with-inoperable-advanced-breast-cancer-abc-after-progression-on-t-dxd-100538995","NCT06298084","Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd","Phase 1b\u002F2, Multicenter, Open-label, Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd","ICARUSBREAST02","Inclusion Criteria:\n\n1. Patients must have received prior treatment with T-DXd and presented disease progression while on T-DXd treatment or within 2 months from T-DXd interruption\u002Fdiscontinuation for any reason, without requiring to be the last line of treatment. Patients who have received other lines of treatment after T-DXd and before study entry is capped at 10 patients for each cohort.\n2. Patients with HER2-positive tumors must have received prior treatment with trastuzumab and taxanes. They may have received prior treatment with T-DM1 and pertuzumab.\n3. Patients with HER2-low tumors must have been treated with taxanes. Patients with HR-positive tumors must have received ET and CDK4\u002F6 inhibitors (patients may have received prior treatment with sacituzumab govitecan) If a patient has a tumor that was previously HER2-pos and became HER2-low, she\u002Fhe will be included in cohort 2 and meet the inclusion criteria for HER2-low tumors.\n\n   If a patient has a tumor that was previously HR-pos and became HR-neg, prior therapy with CDK4\u002F6 inhibitors is not mandatory.\n4. Patients with germline pathogenic BRCA1\u002F2 mutations and HER2-positive or HER2-low breast cancer are eligible to the study but must have received a prior treatment with PARP inhibitor (olaparib or talazoparib)\n5. Female or male patient aged ≥18 years on the day of the ICF signature\n6. Patient who has histologically confirmed diagnosis of breast cancer with unresectable loco regional or metastatic disease\n7. Patient must have an ECOG PS ≤1 at the time of screening\n8. Patients must have HER2-pos (IHC 3+ or IHC2+\u002FISH positive) or HER-2 low (IHC2+\u002FISH negative or IHC 1+) tumors with any HR status, any time before T-DXd exposure\n9. Patient must have at least one radiologically measurable lesion (different from the biopsy site) according to response evaluation criteria in solid tumors (RECIST) V1.1 criteria. At least one predominantly lytic or mixed lytic-blastic bone lesion with identifiable soft tissue component that can be evaluated by Computerized Tomography (CT)\u002FMagnetic Resonance Imaging (MRI) must be present in patients with only bone metastasis\n10. Patient must have a tumor site easily accessible to biopsy, avoiding bone biopsy when possible. Patients must have accepted to perform pre-treatment, on-treatment, and end-of-treatment biopsies\n11. Patient must have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1, defined per the protocol\n12. Female patients of reproductive\u002Fchildbearing potential must have a negative pregnancy test at screening (serum test within 24 hours before C1D1 or urine test within 72 hours of C1D1) and must and must agree to use a highly effective form of contraception or avoid intercourse during and till the end of treatment and for at least 8 months after the last dose of study drug. The following contraception methods are considered highly effective:\n\n    1. Intrauterine device (IUD)\n    2. Bilateral tubal occlusion\n    3. Vasectomized partner\n    4. Complete sexual abstinence defined as refraining from heterosexual intercourse during and till the end of treatment and for at least 8 months for females after the last dose of study drug. Periodic abstinence not an acceptable method of contraception\n13. Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 8 months after the final study drug administration\n14. Male patients must be surgically sterile or must withhold heterosexual intercourse, or must be willing to use a highly effective birth control upon enrollment, during the treatment period, and for at least 5 months following the last dose of study drug\n15. Male patients must not freeze or donate sperm starting at screening and throughout the study period, and for at least 5 months after the final study drug administration.\n16. Patient must understand, sign and date the written informed consent form (ICF) prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedure as per protocol\n17. Patient must be affiliated to a social security system or beneficiary of the same\n\nExclusion Criteria:\n\nThe following exclusion criteria are applicable for all modules. Patients will be excluded if they present one of them:\n\n1. Patient with a breast cancer amenable for resection or radiation therapy with curative intent\n2. Patient with any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have ILD as assessed by imaging during screening\n3. Patient with clinically severe pulmonary compromise (based on investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:\n\n   1. Any underlying pulmonary disorder (eg, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion) OR\n   2. Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis) OR\n   3. Prior pneumonectomy\n4. Patient receiving chronic systemic corticosteroids dosed at \\>10 mg\u002Fday prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Patients who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study\n5. Patient with evidence of any leptomeningeal disease\n6. Patient with clinically significant corneal disease\n7. Patient with any evidence of severe or uncontrolled systemic diseases (e.g. active bleeding diatheses, active infection, or psychiatric illness) which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required for eligibility\n8. Evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Patients with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patients must have a stable neurologic status for at least 2 weeks prior to Cycle 1 Day 1\n9. Inadequate washout period prior to Cycle 1 Day 1, defined as:\n\n   1. Whole brain radiation therapy or stereotactic brain radiation therapy \\\u003C14 days\n   2. Previous treatment with T-DXd \\\u003C 28 days\n   3. Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) from a previous cancer treatment regimen or clinical study \\\u003C14 days or 5 half-lives, whichever is longer\n   4. Endocrine therapy \\\u003C21 days\n   5. Monoclonal antibodies \\\u003C28 days including immune checkpoint inhibitors (ICIs)\n   6. Major surgery (excluding placement of vascular access) \\\u003C28 days\n   7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation \\\u003C28 days or palliative radiation therapy \\\u003C14 days\n   8. Live virus vaccination \\\u003C28 days\n10. Prior treatment with an anti-HER3 antibody\n11. Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Patients with chronic Grade 2 toxicities (defined as no worsening to Grade \\>2 for at least 3 months prior to enrollment and managed with standard of care treatment) that the Investigator deems related to previous anticancer therapy, comprising the following, may be enrolled at the discretion of the Investigator:\n\n    * Chemotherapy-induced neuropathy\n    * Fatigue\n    * Residual toxicities from prior immuno-oncology treatment: Grade 1 or Grade 2 endocrinopathies provided they are clinically stable and receiving hormone replacement therapy when applicable which may include:\n\n      1. Hypothyroidism\u002F hyperthyroidism\n      2. Type I diabetes\n      3. Hyperglycemia\n      4. Adrenal insufficient\n      5. Adrenalitis\n      6. Skin hypopigmentation (vitiligo)\n12. Has known hypersensitivity to either the drug substances or the inactive ingredients of HER3-DXd and\u002For T-DXd\n13. Patient with a history of severe hypersensitivity reactions to other monoclonal antibodies or PARP inhibitors\n14. Has any malignancy other than locally advanced or ABC within 3 years prior to Cycle 1 Day 1, except adequately resected non-melanoma skin cancer or curatively treated in-situ disease or other curatively treated solid tumors\n15. Documented uncontrolled or significant cardiovascular disorder prior to Cycle 1 Day 1, including:\n\n    1. Corrected QT interval \\>450 ms according to Fridericia's formula (QTcF) based on triplicate 12-lead ECGs, approximately 1 minute apart\n    2. LVEF \\\u003C45% by either ECHO or MUGA or cardiac MRI if clinically indicated according to the investigator or consulting cardiologist\n    3. Resting systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg\n    4. Myocardial infarction within 6 months\n    5. Symptomatic congestive heart failure (NYHA class from III to IV)\n    6. Uncontrolled angina pectoris within 6 months\n    7. Cardiac arrhythmia not controlled by ongoing antiarrhythmic treatment\n    8. Diagnosed or suspected long QT syndrome, or known family history of long QT syndrome\n    9. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes\n    10. Patient has bradycardia of less than 50 bpm (as determined by central reading) unless the subject has a pacemaker\n    11. History of second or third degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers\n    12. Coronary\u002Fperipheral artery bypass graft within 6 months\n    13. Complete left bundle branch block\n16. Active Hepatitis B and\u002For Hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of Cycle 1, Day 1. Patients with past or resolved Hepatitis B virus (HBV) infection are eligible if:\n\n    1. Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) positive; OR\n    2. HBsAg positive and HBV deoxyribonucleic acid (DNA) viral load is documented to be ≤ 2000 IU\u002FmL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation with normal transaminases (in the absence of liver metastasis); OR\n    3. HBsAg positive and HBV DNA viral load is documented to be ≤2000 IU\u002FmL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation with liver metastasis and abnormal transaminases AST\u002FALT \\\u003C3 ULN For patients with HBsAg positive, if abnormal liver function is detected during study drug treatment, viral load should be tested to rule out reactivation.\n\n    Patients with a history of Hepatitis C infection will be eligible for enrollment only if the viral load according to local standards of detection, is documented to be below the level of detection in the absence of anti-viral therapy during the previous 12 weeks (ie, sustained viral response according to the local product label but not less than 12 weeks, whichever is longer)\n17. Female patient who is pregnant or breastfeeding or intends to become pregnant during the study\n18. Has a known human immunodeficiency virus (HIV) infection that is not well controlled. All the following criteria are required to define an HIV infection that is well controlled: undetectable viral ribonucleic acid (RNA) load, CD4+ counts\u002Flevels of \\>350 cells\u002FμL, no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months, and stable for at least 3 weeks on same anti-HIV retroviral medications. If an HIV infection meets the above criteria, the patient's viral RNA load and CD4+ cell count should be monitored per local standard of care (eg, every 3 months). Patients with a well-controlled HIV infection may only be enrolled into Part 2 (dose expansion) of the study.\n19. Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's judgment, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or confound the assessment of study results\n20. Adult under legal protection: guardianship, curatorship, or legal protection; or patient deprived of his\u002Fher liberty by a judicial or administrative decision; or patient incapable of giving his\u002Fher consent, or patient under psychiatric care\n21. Participation in another clinical trial evaluating an experimental drug during the last 4 weeks (except non-interventional research) Specific exclusion criteria for each module\n\n    Module 0:\n\n    There are no specific exclusion criteria for module 0 (HER3-DXd monotherapy). Module 1 (olaparib)\n22. History of hypersensitivity to excipients of olaparib\n23. Inadequate washout period prior to Cycle 1 Day 1, defined as:\n\n    1. Strong CYP3A inhibitors \\\u003C 1 week\n    2. CYP3A inducers for olaparib and phenobarbital \\\u003C 5 weeks and for any other drug \\\u003C 3 weeks",{"count":182,"type":20},152,[23,24],"ICARUS-BREAST02 is an open-label, multicenter, phase 1b\u002F2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.\n\nThe first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0).\n\nThe main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd.\n\nThe main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months.",[186,90,28,187],"Breast Cancer Metastatic","Advanced Breast Cancer","2024-03-28",{"date":190,"type":40},"2024-03-29",{"date":192,"type":40},"2024-03-21",{"date":194,"type":20},"2029-06",{"name":196,"class":47},"Gustave Roussy, Cancer Campus, Grand Paris"]