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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)
Phase 2 trial testing Sacituzumab Govitecan in Breast Cancer in 27 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 23 May 2023 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sacituzumab Govitecan — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT05675579
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sacituzumab Govitecan
Trials testing the same drug.
- NCT07504588 — Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and · Phase 2 · not yet recruiting
- NCT07492914 — Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT07328490 — Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Trea · Phase 1, PHASE2 · not yet recruiting
- NCT07368543 — Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer · Phase 2 · not yet recruiting
- NCT06462092 — Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Canc · Phase 1, PHASE2 · recruiting
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Currently open trials in the same condition.
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05675579 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 4 November 2025
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.
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