Phase 2
N=147
Cisplatin vs Paclitaxel for Triple Negative Breast Cancer
Triple Negative Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01982448 ↗Enrolled (actual)
147
Serious AEs
21.6%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Pathologic Response by HR-deficiency (HRD) Status — 9; 2; 10; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cisplatin (Drug); Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pathologic Response by HR-deficiency (HRD) Status |
9; 2; 10; 4; 30; 15 | — |
| SECONDARY Number With Pathologic Complete Response (pCR) by HR-deficiency (HRD) Status |
5; 1; 5; 3; 34; 16 | — |
| SECONDARY Number of Pathologic Response |
19; 15; 53; 52 | — |
| SECONDARY Number With Pathologic Response |
11; 8; 61; 59 | — |
| SECONDARY Positive Predictive Value (PPV) of HRD Score |
.231; .286 | — |
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.
Eligibility Criteria
Inclusion Criteria: 1. Participants must meet the following criteria on screening examination to be eligible to participate in the study 2. Pathologic documentation of invasive breast cancer by biopsy (FNA alone is not adequate). 3. AJCC clinical stage I with T1 > 1.5 cm, stage II or III invasive breast cancer. 4. Participants with multicentric or bilateral disease are eligible if at least one lesion meets stage eligibility criteria for the study and no tumor is HER2-positive. 5. Tumors must be HER2 negative defined as HER2 0 or 1+ by immunohistochemistry (IHC) assays and /or lack of gene amplification by FISH defined as a ratio grade 1 (NCI CTCAE Version 4.0- Appendix B) 7. Significant hearing loss that would prevent cisplatin administration. 8. Renal dysfunction for which exposure to cisplatin would be unsafe or require cisplatin dose modification (i.e., Cre > 1.5 mg/dl or GFR < 60 cc/min).
Data sourced from ClinicalTrials.gov (NCT01982448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.