Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

NCT05633654 · readout ≤ 315 d

Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →. With Alliance Foundation Trials, LLC., NSABP Foundation Inc, GBG Forschungs GmbH.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

1,514estimated

Sites

356

Countries

Australia, Belgium, Brazil +8

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

2022-12-12

actual

When the study began enrolling

Primary completion

Jun 2027

estimated

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

Study completion

Aug 2031

estimated

The whole study's end, after follow-up

First posted

2022-12-01

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-15

actual

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

What it studies

Condition

Triple Negative Breast Cancer

Interventions

Drug: Sacituzumab govitecan-hziy (SG) — also filed as GS-0132, IMMU-132, Trodelvy™
Drug: Pembrolizumab — also filed as KEYTRUDA®
Drug: Capecitabine — also filed as Xeloda

Primary outcome

what the primary-completion date above is the date OF

Invasive Disease-free Survival (iDFS)

measured Up to 60 months

Publications

PMID 38922307 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

Permalink · GILD's whole pipeline · Catalyst calendar · Every registered study · What changed