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NCT06959537
A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC)
Phase 1 trial testing Cyclophosphamide in Breast Cancer in 24 participants. Currently enrolling.
31 January 2027
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 13 August 2025 |
| Primary completion | 31 January 2027 |
| Estimated completion | 31 January 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cyclophosphamide (cyclophosphamide) — full drug profile →
- Axatilimab (SNDX-6352) — full drug profile →
- Retifanlimab (RETIFANLIMAB) — 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
The goal of this clinical research study is to find the best dose of the drugs cyclophosphamide and axatilimab that can be given in combination with the standard dose of retifanlimab to patients with metastatic TNBC.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Anti-CSF-1R therapy with combined immuno-chemotherapy coordinate an adaptive immune response to eliminate macrophage enriched triple negative breast cancers.
Pedroza DA, Yuan X, Liu F, Chan HL, et al · · 2026 · PMID 41484081 · DOI 10.1038/s41467-025-67964-2
Verify or expand the search:
- PubMed search for NCT06959537
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06959537 (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: 10 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/NCT06959537.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing