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RecruitingLast updated: 15 May 2026

ASCENT-05: A study recruiting people with triple negative breast cancer to find out whether giving targeted therapy in combination with immunotherapy after surgery is effective and safe compared to other treatmentsA Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

ASCENT-05

Clinical summary

Summary

You may be eligible for this study if you have triple negative breast cancer that still remains after surgery and pre-surgery treatment (neoadjuvent therapy).

The study is investigating whether sacituzumab govitecan-hziy (SG), which is a kind of targeted cancer medicine called an antibody-drug conjugate, is safe and effective when given in combination with pembrolizumab immunotherapy after surgery. The study will compare this treatment to other pembrolizumab treatments.

Eligible participants will be randomly allocated (by chance) to one of two treatment arms.

In the Experimental Arm, participants will receive SG plus pembrolizumab. Participants will receive SG intravenously (IV) on Days 1 and 8, and pembrolizumab IV on Day 1 of 21-day treatment cycles for 8 cycles.

In the Active Comparator Arm, participants will receive one of the following treatment regimens of the physician's choice:

  • Pembrolizumab IV on Day 1 of 21-day cycles for 8 cycles, OR
  • Pembrolizumab IV on Day 1 and capecitabine chemotherapy orally twice daily on Days 1-14 of 21-day cycles for 8 cycles.

Conditions

This trial is treating people with triple negative breast cancer who have residual disease in the breast or lymph nodes after neoadjuvant therapy and surgery

Eligibility

Inclusion

  • Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:

    • TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).
  • Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
  • Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment.
  • Adequate organ function.

Exclusion

  • Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
  • Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
  • Evidence of recurrent disease following preoperative therapy and surgery.
  • Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
  • Individuals with germline breast cancer gene (BRCA) mutations.
  • Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%
  • Active serious infections requiring anti-microbial therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Gilead Sciences

Scientific Title

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan 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

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