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A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC) | Clinical Trials | Clareo Health

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A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)

NCT05675579•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

To learn if sacituzumab govitecan and pembrolizumab, when given before surgery, can help to control early-stage triple negative breast cancer that has not responded well to other treatments.

Detailed Description

Primary Objective: • To determine the efficacy of sacituzumab govitecan and pembrolizumab combination treatment on pathological complete response (pCR)/residual cancer burden (RCB)-1 in the patients with early-stage TNBC who showed a resistance to the combination of immunochemotherapy. Secondary Objectives: * To determine the safety of the proposed combination treatment. * To determine the objective overall response rate (ORR) of the proposed treatment. * To determine the distant-recurrence-free survival (DRFS). * To determine the 3-year event-free survival (EFS) rate. * To determine the 3-year overall survival (OS) rate. Exploratory Objective: • To investigate the response biomarkers in the tumor tissues and peripheral blood.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Female or male patients 18 years of age or older.
•2. Histologically or cytologically confirmed breast cancer
•3. T1c N1-2 or T2-4 N0-2 early-stage disease
•4. ER/PR negative (ER/PR \<1%) or ER/PR low positive (1%≤ER/PR≤10%), and HER2 negative as per institutional and ASCO-CAP guidelines)
•5. Initiated the NAC with the first regimen of KN-522 regimen (i.e., pembrolizumab 200 mg Q3W, given with 4 cycles of paclitaxel + carboplatin).
•6. ECOG performance score of 0 or 1.
•7. The volumetric change of primary tumor = 0% or increase in volumetric size by US or MRI after completing the first part of the KN-522 regimen.
•8. Negative serum pregnancy test within 72 hours of receiving the first dose of the study medication for women of childbearing potential as per institutional guidelines. Postmenopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo pregnancy tests.
•9. Agreed with undergoing the image-guided core needle biopsy after completing the first part of neoadjuvant treatment regimen.
•10. Subjects of childbearing potential should be willing to use effective birth control methods or be surgically sterile or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of the study drug. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. Effective methods of birth control include:
+10 more criteria

Exclusion Criteria

•1. Stage IV disease
•2. Any other previous antitumor therapies for the current cancer event.
•3. Pregnant or planning to become pregnant during therapy.
•4. Gastrointestinal tract disease or defect or previous history of colitis.
•5. Has an active autoimmune disease that requires systemic therapy within two years of treatment or a medical condition that requires immunosuppression.
•6. Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association \> class II), unstable angina, or unstable cardiac arrhythmia requiring medication.
•7. Has known human immunodeficiency virus (HIV) infection or active hepatitis B or C infection (screen test is not required). Subjects positive for hepatitis C (HCV) antibody are eligible only if the polymerase chain reaction is negative for HCV RNA.
•8. Has a cognitive impairment.
•9. Any other major comorbidities that can impact receiving immunotherapy or Sacituzumab govitecan.
•10. Have live vaccinations within 30 days prior to registration and receive study treatment.

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

May 23, 2023

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

November 4, 2025

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Sacituzumab Govitecan

DRUG

Pembrolizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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