Last reviewed · How we verify
NCT06637306
Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
EARLY_PHASE1 trial testing Dupilumab in Locally Advanced Triple Negative Breast Cancer in 15 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Rima Patel |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 5 March 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 1 June 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dupilumab (DUPILUMAB) — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
- Paclitaxel — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
Conditions studied
- Locally Advanced Triple Negative Breast Cancer — all drugs for Locally Advanced Triple Negative Breast Cancer →
- TNBC - Triple-Negative Breast Cancer — all drugs for TNBC - Triple-Negative Breast Cancer →
Sponsor
Rima Patel
Who can join
18 and older, any sex, with Locally Advanced Triple Negative Breast Cancer or TNBC - Triple-Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pilot trial of the IL-4 receptor antagonist dupilumab plus pembrolizumab, paclitaxel, and carboplatin in locally advanced triple negative breast cancer (TNBC). Primary Objective: To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by the proportion of severe immune-related adverse events (irAEs) in patients with locally advanced TNBC. Secondary Objectives: To determine the rates of pathologic complete response with the addition of dupilumab to NAC and pembrolizumab; to determine the rate of residual cancer burden 0-1; to estimate the recurrence-free survival and overall survival; to assess the toxicity of the combination of dupilumab, pembrolizumab, and paclitaxel-carboplatin.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Tumor secretome shapes the immune landscape during cancer progression.
Yang J, Tang S, Saba NF, Shay C, et al · · 2025 · cited 16× · PMID 39930476 · DOI 10.1186/s13046-025-03302-0 -
Recent Advances in Immune Checkpoint Inhibitors for Triple-Negative Breast Cancer.
Corti C, Koca B, Rahman T, Mittendorf EA, et al · · 2025 · cited 11× · PMID 40196378 · DOI 10.2147/itt.s495751 -
Steroid-sparing strategies for managing immune-related adverse events.
Huang JJ, YousefiAsl M, Singh N, Grivas P, et al · · 2026 · cited 1× · PMID 41545303 · DOI 10.1136/jitc-2025-013776 -
Tumor-infiltrating lymphocytes and tumor-associated macrophages in cancer immunoediting: a targetable therapeutic axis.
Mukherjee S, Ghosh A, Chakraborty S, Basak U, et al · · 2025 · PMID 41019045 · DOI 10.3389/fimmu.2025.1655176
Verify or expand the search:
- PubMed search for NCT06637306
- 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 NCT06637306 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Rima Patel
- Last refreshed: 26 March 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/NCT06637306.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing