CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 543 enrolled
Drug / intervention
Sacituzumab Govitecan-hziy +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03901339
NCT03901339Phase 3Completed
CompareCT.gov

Phase 3 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 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens

Gilead Sciences·interventional·Posted Apr 3, 2019·Updated Oct 21, 2024

In Brief

A Phase 3 clinical trial evaluating Sacituzumab Govitecan-hziy, Eribulin, and 3 other interventions for Metastatic Breast Cancer. Completed, enrolled 543 participants across 113 sites in 9 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesBelgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 3, 2019
Enrollment StartMay 8, 2019
Primary CompletionOct 20, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.2 years ago

Interventions

Sacituzumab Govitecan-hziydrug

Administered intravenously

Eribulindrug

Administered intravenously per NCCN guidelines

Capecitabinedrug

Administered orally per NCCN guidelines

Gemcitabinedrug

Administered intravenously per NCCN guidelines

Vinorelbinedrug

Administered intravenously per NCCN guidelines