Recruiting NCT05633654

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)

Phase III Interventional Triple Negative Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine.
Who it may be relevant to: Registry conditions: Triple Negative Breast Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, France +6
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

Drug Sacituzumab govitecan-hziy (SG)
Administered intravenously
Drug Pembrolizumab
Administered intravenously
Drug Capecitabine
Tablets administered orally

Primary outcome measures

Invasive Disease-free Survival (iDFS) [Time frame: Up to 60 months]

Secondary outcome measures (6)

Overall Survival (OS) [Time frame: Up to 96 months]
Distant Disease-free Survival (dDFS) [Time frame: Up to 60 months]
Recurrence-free Survival (RFS) [Time frame: Up to 60 months]
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Time frame: First dose date up to 38 months plus 30 days]
Percentage of Participants Experiencing Laboratory Abnormalities [Time frame: First dose date up to 38 months plus 30 days]
Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores [Time frame: Up to 60 months]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment