RightFit
RecruitingPhase 3

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)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective sacituzumab govitecan-hziy (SG) plus pembrolizumab is after surgery. It compares this with pembrolizumab alone or with capecitabine. It is for adults with triple-negative breast cancer who had cancer left in tissue removed during surgery after treatment given before surgery.

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18, with cancer left in breast or lymph node tissue removed during surgery after treatment given before surgery.
  • Have triple-negative breast cancer that meets the study’s test rules: estrogen and progesterone receptor levels of 10% or less, and a negative HER2 test.
  • Have had all visible cancer in the breast and/or lymph nodes removed, and have recovered enough from surgery.
  • Provide tumor samples from both the biopsy before treatment and the surgery.
  • Be fully active or able to do light work despite some limits on strenuous activity.
  • Have had radiation treatment as required by local care practices and recovered before starting study treatment.
  • Have organs that work well enough for the study.

Who can't join

  • Have breast cancer that has spread to distant parts of the body, or any earlier invasive breast cancer in either breast.
  • Have had certain drugs that affect immune cells called T cells, or any treatment aimed at HER2.
  • Have had hormone therapy for more than 4 weeks, or plan to use it during study treatment.
  • Have cancer that came back after treatment before surgery and surgery.
  • Have had topoisomerase 1 inhibitors, drugs that block an enzyme cancer cells use, or antibody-linked drugs carrying a topoisomerase inhibitor.
  • Have an inherited change in a BRCA gene.
  • Have had a heart attack or unstable chest pain within 6 months, a history of serious heart rhythm or electrical signal problems, or a heart pumping measure below 50%.
  • Have a serious active infection that needs medicine to treat it.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.

Study sites (188)

AL

AZ

CA

CO

CT

DC

FL

GA

IA

ID

IL

IN

KS

KY

LA

MA

MD

ME

MI

MN

MO

NC

NE

NJ

NM

NV

NY

OH

OK

OR

PA

RI

SC

SD

TN

TX

UT

VA

WA

WI

WV