Cisplatin vs Paclitaxel for Triple Negative Breast Cancer (NCT01982448) | Clinical Trial Compass
CompletedPhase 2
Cisplatin vs Paclitaxel for Triple Negative Breast Cancer
United States147 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 \< 2 on invasive tumor by local review. 6. ER and PgR status by IHC must be known. Tumor must be ER and PR negative (ā¤5% staining) by local review. 7. Known BRCA1/2 (BReast CAncer) status is not required for study entry. However patients known to have a germline deleterious BRCA1/2 mutation should be encouraged to consider a preoperative trial specifically designed for BRCA1/2 carriers, if available. 8. Breast imaging should include imaging of the ipsilateral axilla. For subjects with a clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be performed to confirm the presence of metastatic disease in the lymph nodes. For patients with a clinically negative axilla, baseline assessment of the axilla will be performed at the discretion of the treating investigator. For patients with pathologically positive axillary lymph nodā¦
What they're measuring
1
Number of Participants With Pathologic Response by HR-deficiency (HRD) Status
Timeframe: Evaluated after definitive breast surgery, up to 4-5 months from enrollment.