drugset / Trial / NCT01982448
Cisplatin vs Paclitaxel for Triple Negative Breast Cancer
Phase 2
Completed
147 enrolled
Dana-Farber Cancer Institute
Myriad Genetics, Inc. · collabTranslational Breast Cancer Research Consortium · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase II study randomizing patients with stage I with T1 \> 1.5 cm, stage II or III triple negative breast cancer (TNBC) to preoperative cisplatin versus paclitaxel. The study is designed to evaluate the ability of the Homologous Recombination Deficiency (HRD) assay to predict pathologic response to preoperative chemotherapy.
Timeline
- Start
- 2014-04
- Primary completion
- 2019-01
- Completion
- 2020-08
Publications
- Results Mayer EL, Abramson V, Jankowitz R, Falkson C, Marcom PK, Traina T, Carey L, Rimawi M, Specht J, Miller K, Stearns V, Tung N, Perou C, Richardson AL, Componeschi K, Trippa L, Tan-Wasielewski Z, Timms K, Krop I, Wolff AC, Winer EP. TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker. Ann Oncol. 2020 Nov;31(11):1518-1525. doi: 10.1016/j.annonc.2020.08.2064. Epub 2020 Aug 13.
- Nader-Marta G, Chu X, Mukhopadhyay S, Abramson VG, Brufsky A, Stringer-Reasor EM, Dent SF, Traina TA, Carey LA, Rimawi MF, Specht JM, Miller KD, Santa-Maria CA, Dasgupta T, Kurt BB, DeMeo M, Krop IE, Tung NM, Schnitt SJ, Tayob N, Mayer EL. Prognostic value of visually and computationally assessed tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer (TBCRC-030). J Natl Cancer Inst. 2026 Jan 1;118(1):141-149. doi: 10.1093/jnci/djaf289.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |