NCT05840211进行中（未招募）3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 654
- 试验地点
- 286
- 主要终点
- 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)
研究概览
简要总结
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), 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
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.
研究组 & 干预措施
Sacituzumab Govitecan-hziy (SG)
Experimental
Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.
干预措施: Sacituzumab Govitecan-hziy (Drug)
Treatment of Physician's Choice (TPC)
Active Comparator
Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens:
- paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.
- nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.
- capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.
干预措施: Paclitaxel (Drug)
Treatment of Physician's Choice (TPC)
Active Comparator
Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens:
- paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.
- nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.
- capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.
干预措施: Nab-paclitaxel (Drug)
Treatment of Physician's Choice (TPC)
Active Comparator
Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens:
- paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.
- nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle.
- capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.
干预措施: Capecitabine (Drug)
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)
时间窗: 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)
- Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1(Until progression or death, up to approximately 60 months)
- Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities(First dose date up to 30 days post last dose, 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)
- 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)
- 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)
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(First dose date up to 30 days post last dose, up to approximately 60 months)
- Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1(Up to approximately 60 months)
研究者
研究点 (286)
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