Cisplatin vs Paclitaxel for Triple Negative Breast Cancer
A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker
2 other identifiers
interventional
147
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2014
Longer than P75 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedResults Posted
Study results publicly available
June 18, 2021
CompletedSeptember 30, 2025
September 1, 2025
4.8 years
October 28, 2013
February 24, 2021
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Pathologic Response by HR-deficiency (HRD) Status
Pathologic response was assessed using the MD Anderson residual cancer burden (RCB) method (Symmans et al. JCO 2007). Responders are defined as RCB 0/1 and non-responders as RCB 2/3. Participants who crossed over due inadequate clinical response after 12 weeks were counted as non-responders. HRD status was determined with baseline diagnostic tissue using the HRD assay (Myriad Genetics, Inc.; required minimum 100 mm2 of tumor tissue) which detects impaired double-strand DNA break repair. The positive threshold for HRD was a score \>/= 33.
Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Secondary Outcomes (4)
Number With Pathologic Complete Response (pCR) by HR-deficiency (HRD) Status
Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Number of Pathologic Response
Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Number With Pathologic Response
Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Positive Predictive Value (PPV) of HRD Score
Evaluated after definitive breast surgery, up to 4-5 months from enrollment.
Study Arms (2)
Arm A: Cisplatin
EXPERIMENTALCisplatin given by IV infusion at a dose of 75 mg/m2 every 3 weeks (1 cycle) for 4 cycles as preoperative chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to crossover to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
Arm B: Paclitaxel
EXPERIMENTALPaclitaxel given by IV infusion at a dose of 80 mg/m2 weekly for 12 weeks (4 cycles) as neoadjuvant chemotherapy. Participants with inadequate clinical response after 12 weeks (as judged either clinically or radiologically by a provider) were able to 'crossover' to an alternative provider-selected preoperative chemotherapy regimen. Definitive breast surgery following no later than 42 days after administration of last chemotherapy.
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Myriad Genetics, Inc.collaborator
- Translational Breast Cancer Research Consortiumcollaborator
Study Sites (20)
University of Alabama
Birmingham, Alabama, 35294, United States
Indiana University- Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
South Shore Hospital
Weymouth, Massachusetts, 02190, United States
Memorial Sloan Kettering Cancer Center-Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center-Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center-Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center-West Harrison
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center-Rockville Centre
Rockville Centre, New York, 11570, United States
Memorial Sloan Kettering Cancer Center-Sleepy Hollow
Sleepy Hollow, New York, 10591, United States
University of North Carolina- Lineberger Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
Universtiy of Pittsburgh- Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Seattle Cancer Alliance at EvergreenHealth
Kirkland, Washington, 98034, United States
University of Washignton
Seattle, Washington, 98195, United States
Related Publications (2)
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.
PMID: 32798689RESULTNader-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.
PMID: 41075163DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Office
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Erica Mayer, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Invesitigator
Study Record Dates
First Submitted
October 28, 2013
First Posted
November 13, 2013
Study Start
April 1, 2014
Primary Completion
January 1, 2019
Study Completion
August 1, 2020
Last Updated
September 30, 2025
Results First Posted
June 18, 2021
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share