此临床研究旨在了解sacituzumab govitecan-hziy（SG）能否延长HR+/HER2-转移性乳腺癌患者的生存期，以及其肿瘤能否在与现有标准治疗（如paclitaxel、nab-paclitaxel或capecitabine）比较下不出现生长或扩散。主要目标为比较SG相对研究者选择治疗（TPC）对无进展生存期（PFS）的影响。
适应症：Locally Advanced or Unresectable Metastatic Breast Cancer、Stage IV Breast Cancer
入组条件
纳入标准
- 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 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.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。