drugset / Trial / NCT03716180
DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC
Phase 1
Active not recruiting
100 enrolled
Dana-Farber Cancer Institute
Breast Cancer Research Foundation · collabSusan G. Komen Breast Cancer Foundation · collabTerri Brodeur Breast Cancer Foundation · collab
NaSingle-groupOpen-labelTreatment
Summary
This research study is studying whether participants and their doctors are willing to determine post-surgery treatment on the basis of response to pre-surgery treatment, and studying blood and tissue collected from participants treated with a combination of drugs as a treatment for breast cancer. The names study drugs involved in this study are: * Paclitaxel (also called Taxol) * Trastuzumab (also called Herceptin) * Pertuzumab (also called Perjeta)
Timeline
- Start
- 2018-11-05
- Primary completion
- 2020-10-08
- Completion
- 2030-09-01
Publications
- Tarantino P, Li T, Ogayo ER, Rahman T, DiLullo MK, Patel A, El-Refai S, Abbott C, Li B, Boyle SM, Chen RO, Desai NV, Spring LM, Tung NM, Sinclair N, Faggen M, Constantine M, King TA, Krop IE, Tayob N, Mittendorf EA, Tolaney SM, Winer EP, Parsons HA, Waks AG. Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab for Stage II to III, ERBB2-Positive Breast Cancer: A Secondary Analysis of the DAPHNe Trial. JAMA Oncol. 2026 Jun 25. doi: 10.1001/jamaoncol.2026.2023. Online ahead of print.
- Weiss A, Li T, Desai NV, Tung NM, Poorvu PD, Partridge AH, Nakhlis F, Dominici L, Sinclair N, Spring LM, Faggen M, Constantine M, Krop IE, DeMeo M, Wrabel E, Alberti J, Chikarmane S, Tayob N, King TA, Tolaney SM, Winer EP, Mittendorf EA, Waks AG. Impact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial. J Am Coll Surg. 2023 Aug 1;237(2):247-256. doi: 10.1097/XCS.0000000000000761. Epub 2023 May 17.
- Waks AG, Desai NV, Li T, Poorvu PD, Partridge AH, Sinclair N, Spring LM, Faggen M, Constantine M, Metzger O, Alberti J, Deane J, Rosenberg SM, Frank E, Tolaney SM, Krop IE, Tung NM, Tayob N, King TA, Mittendorf EA, Winer EP. A prospective trial of treatment de-escalation following neoadjuvant paclitaxel/trastuzumab/pertuzumab in HER2-positive breast cancer. NPJ Breast Cancer. 2022 May 10;8(1):63. doi: 10.1038/s41523-022-00429-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | — | Intravenous |
| Subject | Pertuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | — | Intravenous |