A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

Gilead Sciences K.K.0 个研究点目标入组 654 人开始时间: 2023年8月16日最近更新: 2024年9月3日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Gilead Sciences K.K.
入组人数: 654
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•Able to understand and give written informed consent.
•Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site.
•Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site.
•Documented evidence of HER2- status.
•Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria.
•Candidate for the first chemotherapy in the locally advanced or metastatic setting.
•Eligible for capecitabine, nab-paclitaxel, or paclitaxel.
•Individuals must have at least one of the following:
•Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting.
•>Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting.
•Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting.
•Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting.
•Individuals may have received prior targeted therapies, including but not limited to phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations) or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies.
•Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
•Demonstrates adequate organ function.
•Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

排除标准

•Progressive disease within 6 months of completing (neo) adjuvant chemotherapy.
•Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
•Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.
•> Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization.
•Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I.
•Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC.
•Have an active second malignancy.
•Have an active serious infection requiring antibiotics.
•Have active hepatitis B virus (HBV) or hepatitis C virus (HCV).
•Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
•Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth.
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

结局指标

主要结局

Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [Time Frame: Up to approximately 29 months] PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.

次要结局

Overall Survival (OS)(Until death, up to approximately 60 months)
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1(Until progression, up to approximately 60 months)
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16(Baseline, Week 16)
Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores(Up to approximately 60 months)
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)(Until progression or death, up to approximately 60 months)
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1(Up to approximately 60 months)
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1(Until progression or death, up to approximately 60 months)

研究者

发起方

Gilead Sciences K.K.

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