Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)

Gilead Sciences

Status and phase: Active, not recruiting; Phase 3

Conditions: Metastatic Breast Cancer

Treatments: Drug: Capecitabine Oral Product; Drug: Gemcitabine Injection; Drug: Vinorelbine injection; Drug: Sacituzumab Govitecan-hziy; Drug: Eribulin Mesylate Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04639986

CTR20210096 (Other Identifier)

EVER-132-002

Details and patient eligibility

About

The goal of this study is to compare the study drug, sacituzumab govitecan-hziy, versus doctors' treatment of choice in participants with HR+/HER2- metastatic breast cancer (MBC) who have failed at least 2 prior chemotherapy regimens.

Full description

Approximately 330 eligible participants will be randomly allocated to one of the following 2 treatment arms in a 1:1 ratio:

Investigational Arm:

Sacituzumab Govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 (21-day cycle).

Control Arm:

Recommended doses and schedules as per package insert depending on region. Eribulin; Capecitabine; Gemcitabine; Vinorelbine Participants will be treated until disease progression as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Female or male individuals aged ≥18 years at the time of signing the informed consent form
• Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed
• Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC
• Should have been previously treated with at least 1 taxane in any setting, at least 1 prior anticancer hormonal treatment in any setting
• Eligible for one of the chemotherapy options listed in the TPC arm
• Documented radiographic disease progression after the most recent therapy
• Measurable disease by CT or MRI in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.
• Adequate bone marrow function, hepatic and renal function
• 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
• Individuals who have known brain metastases.
• Have an active second malignancy within 3 years prior to providing informed consent
• Individuals with active hepatitis B virus (HBV), or hepatitis C virus infection (measurable viral RNA load with polymerase chain reaction).
• Active serious infection requiring systemic antibiotic use within 7 days before Cycle1 Day 1.
• Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
• Known hypersensitivity or intolerance to either of the study treatments or any of the excipients.

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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331 participants in 2 patient groups

Sacituzumab Govitecan-hziy

Experimental group

Description:

Participants will receive Sacituzumab Govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle.

Treatment:

Drug: Sacituzumab Govitecan-hziy

Treatment of Physician's Choice (TPC)

Active Comparator group

Description:

Participants will receive recommended doses and schedules as per package insert depending on region. * Eribulin (1.4 mg/m\^2 of eribulin mesylate or 1.23 mg/m\^2 of eribulin on Days 1 and 8 of a 21-day cycle) * Capecitabine (1000 to 1250 mg/m\^2 twice daily on Days 1 to 14 of a 21-day cycle) * Gemcitabine (800 to 1200 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle) * Vinorelbine (25 mg/m\^2 on Day 1 weekly)

Treatment:

Drug: Eribulin Mesylate Injection

Drug: Vinorelbine injection

Drug: Gemcitabine Injection

Drug: Capecitabine Oral Product