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NCT Number: NCT04639986

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Hospital Chinese Academy of Medical Science, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sacituzumab Govitecan-hziy

Drug

Sacituzumab govitecan 10 mg/kg via IV injection administered on Days 1 and 8 of a 21-day cycle. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.

Other names: IMMU-132, Trodelvy™, GS-0132

Eribulin mesylate injection

Drug

Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

Other names: Halaven

Capecitabine Oral Product

Drug

Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.

Other names: Xeloda

Gemcitabine injection

Drug

Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

Other names: Gemzar

Vinorelbine injection

Drug

Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.

Other names: Navelbine

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: Up to 4 years

    PFS is defined as from the date of randomization until the date of disease progression (PD) or death, whichever occurs earlier. Disease progression will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) by Independent Reviewing Committee (IRC).

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 4 years

    OS is defined as from the date of randomization to death from any cause.

  2. Objective Response Rate (ORR) by IRC

    Time frame: Up to 4 years

    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).

  3. Duration of Response (DOR) by IRC

    Time frame: Up to 4 years

    DOR is defined as from the date of first onset of tumor response (CR or PR) to PD or death, whichever occurs earlier.

  4. Clinical Benefit Rate (CBR) by IRC

    Time frame: Up to 4 years

    CBR is defined as best overall response of CR or PR or durable stable disease (SD) (duration of SD ≥ 6 months after randomization).

  5. Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Time frame: First dose date up to 4 years plus 30 days

  6. Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0

    Time frame: First dose date up to 4 years plus 30 days

  7. Change From Baseline of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30, Version 3.0 (EORTC QLQ-C30) Score

    Time frame: Baseline, up to 4 years

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) to assess 15 scales; 1 global health status/quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social), and 9 symptom/item scales(fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

  8. Change From Baseline of the European Quality of Life 5-Dimensions 5 Levels Instrument (EuroQOL EQ-5D-5L) Score

    Time frame: Baseline, up to 4 years

    The EQ-5D-5L is an instrument for use as a measure of health outcome.The EQ-5D-5L consists of 2 sections: the EuroQoL (5 dimensions) (EQ-5D) descriptive system and the EuroQoL visual analogue scale (EQ-VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ-VAS indicate better health.

  9. Percentage of Participants Experiencing Treatment-Emergent Adverse Events Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE)

    Time frame: Baseline, up to 4 years

    NCI PRO-CTCAE is a patient-reported item library used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The items selected for this study include: decreased appetite, nausea, vomiting, constipation, diarrhea, abdominal pain, shortness of breath, hair loss, and fatigue.

  10. Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38

    Time frame: Up to 4 years

    Cmax is defined as the maximum observed concentration of drug.

  11. PK Parameter: Tmax of of Sacituzumab Govitecan-hziy and Free SN-38

    Time frame: Up to 4 years

    Tmax is defined as the time to maximum drug concentration.

  12. PK Parameter: Ctrough of Sacituzumab Govitecan-hziy and Free SN-38

    Time frame: Up to 4 years

    Ctrough is defined as the concentration of drug at the end of the dosing interval.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3 Asian Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 23, 2020
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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