BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer

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NCT06756932 · readout in 345 d

Sponsored by BeOne Medicines (industry) · ONC — their whole pipeline →.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

120estimated

Sites

Countries

Australia, China, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-02-04

actual

When the study began enrolling

Primary completion

2027-07-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2027-07-30

estimated

The whole study's end, after follow-up

First posted

2025-01-03

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-06-22

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Hormone-receptor-positive Breast Cancer
HER2-negative Breast Cancer
Metastatic Breast Cancer

Interventions

Drug: BGB-21447
Drug: Fulvestrant
Drug: BGB-43395

Primary outcomes

what the primary-completion date above is the date OF

Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From the first dose of study drug(s) to 30 days after the last dose; up to approximately 6 months

Part 1: Recommended Dose for Expansion (RDFE) of BGB-21447 in combination with fulvestrant and in combination with fulvestrant and BGB-43395

measured From first dose of the study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first, up to approximately 6 to 9 months

Part 2: Objective Response Rate (ORR)

measured Approximately 12 months

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