PER-040-23尚未招募3 期
A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING EFFICACY AND SAFETY OF GIREDESTRANT COMPARED WITH FULVESTRANT, BOTH COMBINED WITH A CDK4/6 INHIBITOR, IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WITH RESISTANCE TO PRIOR ADJUVANT ENDOCRINE THERAPY
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Signed Informed Consent Form
- •Age >/= 18 years at time of signing Informed Consent Form
- •Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- •Documented ER+ tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) (Allison et al. 2020) or ESMO guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines, defined as = 1% of tumor cells stained positive, assessed locally based on the most recent tumor biopsy (or archived tumor sample)
- •Documented HER2- tumor according to ASCO/CAP (Wolff et al. 2023) or ESMO guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines, assessed locally based on the most recent tumor biopsy (or archived tumor sample)
- •Confirmed ESR1 mutation status (mutation detected [ESR1m] vs. no mutation detected [ESR1nmd]) in baseline ctDNA, as assessed through central laboratory testing of a blood sample freshly collected at screening, using the investigational FMI F1LCDx assay. A valid central testing result using investigational F1LCDx is always required; in localities where FMI central testing is not available, samples will be submitted to an alternative, Sponsor-designated central laboratory. Participants without a valid ESR1 mutation status central result (i.e., unknown ESR1 mutation status that cannot be classified as ESR1m or ESR1nmd) are not eligible.
- •Consent to provide and confirmed availability of the most recently collected and representative tumor tissue specimen suitable for biomarker testing with associated pathology (i.e., archived formalin-fixed paraffin-embedded tissue block [preferred] or 15-20 slides containing unstained, freshly cut, serial sections). See Section 8.7 and the laboratory manual for specimen requirements.
- •Participants who have relapsed with prior standard adjuvant ET with an AI (i.e., anastrozole, letrozole, or exemestane) and/or a SERM (i.e., tamoxifenor toremifene), on-treatment after = 12 months or off-treatment within 12 months of completion (i.e., treatment-free interval < 12 months).
- •No history of systemic anti-cancer therapy for locally advanced or metastatic disease.
- •Measurable disease as defined per RECIST v.1.1 or non-measurable bone-only disease which must be evaluable defined as having at least one predominantly lytic bone lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) which can be followed (soft tissue component not required).
排除标准
- •Disease recurrence during the first 12 months of adjuvant ET
- •Prior systemic therapy for metastatic breast cancer (e.g., prior chemotherapy, immunotherapy, or biologic therapy for locally advanced unresectable or metastatic disease)
- •Prior treatment with a SERD (e.g., fulvestrant, novel oral), proteolysis targeting chimera, complete ER antagonist (CERAN), or novel SERM (other than tamoxifen, toremifene)
- •Treatment with any investigational therapy within 28 days prior to randomization, or within 5 half-lives of the investigational drug(s), whichever is longer
- •Radiotherapy or any other anti-cancer therapy within 2 weeks before randomization
- •Major surgical procedure or significant traumatic injury within 28 days prior to randomization
- •Exposure to strong CYP3A4 inhibitors, strong CYP3A4 inducers, and moderate CYP3A inducers (for participants who will receive abemaciclib only) within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
- •Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term (including massive uncontrolled effusions [pleural, pericardial, peritoneal] or pulmonary lymphangitis) appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines
- •History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence including, but not limited to, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, papillary thyroid cancer treated with surgery, or Stage I endometrial cancer. The Medical Monitor is available for consultation
- •Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
研究者
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