What is sacituzumab govitecan-hziy studying for triple negative breast cancer?

Sacituzumab govitecan-hziy is being studied in combination with pembrolizumab to see if it improves outcomes after surgery in people with triple negative breast cancer that remains after prior treatment. The study, sponsored by Gilead Sciences, compares this new approach to standard treatments chosen by physicians. Participants will help determine if this combination is effective and safe in this setting.

Who may be eligible for this triple negative breast cancer clinical trial?

Adults 18 years or older with triple negative breast cancer remaining after surgery and previous treatment may be eligible. Both men and women can participate if they have adequate organ function and have recovered from surgery and radiotherapy. People with certain prior cancer treatments, active infections, or specific heart conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this triple negative breast cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should consider these potential costs when joining the trial.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05633654

A Randomized, Open-label Study of Sacituzumab Govitecan and Pembrolizumab Versus Physicians Choice Treatment in Triple Negative Breast Cancer With Residual Disease After Surgery

Led by Gilead Sciences · Updated on 2026-04-30

1514

Participants Needed

339

Research Sites

217 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate if the experimental combination of sacituzumab govitecan-hziy SG and pembrolizumab given after surgery is effective and safe compared to the treatment of physicians choice TPC in adults with triple negative breast cancer TNBC who still have invasive disease after surgery and pre-surgical treatment. The study focuses on participants whose cancer remains after neoadjuvant therapy and surgery, exploring new options to improve outcomes in this challenging condition. Participants are randomly assigned to one of two treatment groups. One group receives sacituzumab govitecan-hziy intravenously at 10 mgkg on Days 1 and 8 of a 21-day cycle plus pembrolizumab 200 mg intravenously on Day 1 of each cycle, for up to 8 cycles. The other group receives the treatment of physicians choice, which includes pembrolizumab alone or pembrolizumab plus oral capecitabine for 8 cycles. Treatment continues until 8 cycles are completed, disease recurrence, unacceptable side effects, physician decision, withdrawal, or death. During the study, participants undergo regular assessments to measure invasive disease-free survival for up to 60 months as the primary outcome. Secondary outcomes include overall survival up to 96 months, distant disease-free survival, recurrence-free survival, and monitoring of treatment side effects and laboratory abnormalities. Researchers also evaluate quality of life using questionnaires. The total participation includes treatment cycles followed by long-term monitoring to assess effectiveness and safety over several years.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age over 18 years
Residual invasive triple negative breast cancer in breast or lymph nodes after neoadjuvant therapy and surgery
Estrogen receptor and progesterone receptor levels 10% or less, HER2-negative according to ASCO/CAP guidelines
Adequate excision and surgical removal of all clinically evident disease
Submission of pre-neoadjuvant biopsy and resected residual invasive disease tissue
ECOG performance status 0-1
Received appropriate radiotherapy and recovered before starting study treatment
Adequate organ function

You will not qualify if you...

Stage IV (metastatic) breast cancer or history of any prior invasive breast cancer
Prior treatment with stimulatory or coinhibitory T-cell receptor agents, HER2-directed agents, endocrine therapy over 4 weeks, or planned concurrent endocrine therapy
Evidence of recurrent disease after preoperative therapy and surgery
Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates containing topoisomerase inhibitors
Germline BRCA mutations
Recent myocardial infarction or unstable angina within 6 months
History of serious ventricular arrhythmias, high-grade atrioventricular block, or other cardiac arrhythmias
Left ventricular ejection fraction less than 50%
Active serious infections requiring antimicrobial therapy
Other protocol-defined inclusion/exclusion criteria may apply

Research Team

Gilead Clinical Study Information Center

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