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NCT05675579

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

Active, enrolled Phase 2 Last updated 4 November 2025
What this trial tests

Phase 2 trial testing Sacituzumab Govitecan in Breast Cancer in 27 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
23 May 2023
Primary endpoint
31 December 2026
31 December 2026

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment27
Start date23 May 2023
Primary completion31 December 2026
Estimated completion31 December 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current and future immunotherapy for breast cancer.
    Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z
  2. Advances in Trop-2 targeted antibody-drug conjugates for breast cancer: mechanisms, clinical applications, and future directions.
    Tong Y, Fan X, Liu H, Liang T. · · 2024 · cited 20× · PMID 39555080 · DOI 10.3389/fimmu.2024.1495675
  3. Improving efficacy of TNBC immunotherapy: based on analysis and subtyping of immune microenvironment.
    Yang Y, Li H, Yang W, Shi Y. · · 2024 · cited 11× · PMID 39430759 · DOI 10.3389/fimmu.2024.1441667
  4. Progress and Innovative Combination Therapies in Trop-2-Targeted ADCs.
    Jiang Y, Zhou H, Liu J, Ha W, et al · · 2024 · cited 11× · PMID 38794221 · DOI 10.3390/ph17050652
  5. Advances in the study of marketed antibody-drug Conjugates (ADCs) for the treatment of breast cancer.
    Liang Y, Zhang P, Li F, Lai H, et al · · 2023 · cited 10× · PMID 38352694 · DOI 10.3389/fphar.2023.1332539
  6. Novel treatment approaches utilizing antibody-drug conjugates in breast cancer.
    Davis AA, Hesse J, Pereira PMR, Ma CX. · · 2025 · cited 8× · PMID 40360516 · DOI 10.1038/s41523-025-00743-w
  7. Navigating antibody‒drug conjugates (ADCs): from metastatic to early breast cancer treatment strategies.
    Najdi T, Awad L, Chartouni A, Soueidy C, et al · · 2025 · cited 5× · PMID 40304863 · DOI 10.1007/s10637-025-01525-8
  8. Use of Antibody-Drug Conjugates in the Early Setting of Breast Cancer.
    Koukoutzeli C, Trapani D, Ascione L, Kotteas E, et al · · 2024 · cited 5× · PMID 38894701 · DOI 10.1177/11795549241260418

Verify or expand the search:

Other trials of Sacituzumab Govitecan

Trials testing the same drug.

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05675579.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing