Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01525966|
Recruitment Status : Recruiting
First Posted : February 3, 2012
Last Update Posted : September 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Breast Cancer Stage IIA Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Triple-negative Breast Cancer Stage IIB Breast Cancer Estrogen Receptor Negative Progesterone Receptor Negative HER2/Neu Negative||Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Other: laboratory biomarker analysis||Phase 2|
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|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer|
|Actual Study Start Date :||February 15, 2012|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
U.S. FDA Resources
Experimental: Treatment (carboplatin and nab-paclitaxel)
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
- pCR or Symmans 0-1 pathological response [ Time Frame: At completion of definitive surgery ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525966
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Yuan Yuan, MD, PhD 800-826-4673 firstname.lastname@example.org|
|Principal Investigator: Yuan Yuan, MD, PhD|
|City of Hope- South Pasadena Cancer Center||Recruiting|
|South Pasadena, California, United States, 91030|
|Contact: Stephen C. Koehler 626-396-2900 email@example.com|
|Principal Investigator: Stephen C. Koehler, MD|
|Principal Investigator:||Yuan Yuan, MD, PhD||City of Hope Medical Center|