Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer (TROPiCS-02)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Metastatic Breast Cancer

Treatments: Drug: Eribulin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Sacituzumab Govitecan-hziy; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03901339

IMMU-132-09

2018-004201-33 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

Enrollment: 543 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed.

• Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease:

  • At least 1 taxane in any setting.
  • At least 1 prior anticancer hormonal treatment in any setting.
  • At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting.

• Eligible for one of the chemotherapy options listed in the TPC arm.

• Documented disease progression after the most recent therapy.

• Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm^3, platelets ≥ 100,000 per mm^3).

• Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula .

• Adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilbert's syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 5.0 x IULN)).

• Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin (ß-hCG)).

Key Exclusion Criteria:

• Previous treatment with topoisomerase 1 Inhibitors as a free form or as other formulations.
• History of significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality.
• Active serious infection requiring antibiotics.
• Any medical or other condition which, in the opinion of the Investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason.
• Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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543 participants in 2 patient groups

Sacituzumab Govitecan-hziy

Experimental group

Description:

Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle.

Treatment:

Drug: Sacituzumab Govitecan-hziy

Treatment of Physician's Choice (TPC)

Active Comparator group

Description:

Participants will receive TPC determined prior to randomization from one of the following single-agent treatment: Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic) * Eribulin: 1.4 mg/m\^2 for North American sites, 1.23 mg/m\^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle * Capecitabine: 1000-1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle * Gemcitabine: 800-1200 mg/m\^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution * Vinorelbine: 25 mg/m\^2 via IV on Day 1 weekly cycle per institution

Treatment:

Drug: Capecitabine

Drug: Gemcitabine

Drug: Vinorelbine

Drug: Eribulin