Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
This phase II trial studies how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together before surgery works in treating patients with locally advanced or inflammatory triple negative breast cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Inflammatory Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Triple-negative Breast Cancer
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer|
- pCR or Symmans 0-1 pathological response [ Time Frame: At completion of definitive surgery ] [ Designated as safety issue: No ]A two stage design using MD Anderson criteria of lack of evidence of any residual invasive tumor in breast and/or regional lymph node.
- Overall survival [ Time Frame: 5 years from completion of study treatment ] [ Designated as safety issue: No ]Estimated by the Kaplan-Meier method. The corresponding median survival times (with 90% confidence limits) will be determined.
- Progression-free survival [ Time Frame: 5 years from completion of study treatment ] [ Designated as safety issue: No ]Estimated by the Kaplan-Meier method. The corresponding median survival times (with 90% confidence limits) will be determined.
- Number of patients experiencing serious adverse events (SAEs) graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]SAEs will be characterized by type of adverse event and grade, and by the time of onset in relation to the first day of therapy for each cycle. Attribution of SAEs to treatment (unrelated, unlikely, possible, probable, or definite) will also be reported. The cumulative percentage of patients experiencing treatment-related SAEs and its relationship to treatment duration will also be reported.
|Study Start Date:||February 2012|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy)
Patients receive carboplatin IV over 30 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once weekly. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: paclitaxel albumin-stabilized nanoparticle formulation
Other Names:Other: laboratory biomarker analysis
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01525966
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: George Somlo, MD 800-826-4673 email@example.com|
|Principal Investigator: George Somlo, MD|
|City of Hope- South Pasadena Cancer Center||Recruiting|
|South Pasadena, California, United States, 91030|
|Contact: Stephen C. Koehler 626-396-2900 firstname.lastname@example.org|
|Principal Investigator: Stephen C. Koehler, MD|
|Principal Investigator:||George Somlo||City of Hope Medical Center|