Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00096343|
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : December 4, 2013
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating women who are undergoing surgery for newly diagnosed, locally advanced breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: carboplatin Drug: paclitaxel||Phase 2|
- Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin.
- Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen.
- Determine the tolerability and toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients with non-palpable lymph nodes undergo sentinel lymph node biopsy within 4 weeks before beginning neoadjuvant chemotherapy.
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo lumpectomy or modified radical mastectomy. Patients with a positive sentinel lymph node biopsy or palpable axillary adenopathy undergo axillary lymph node dissection. All patients undergoing lumpectomy or mastectomy with high-risk disease also undergo radiotherapy.
Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core needle biopsy.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
U.S. FDA Resources
Experimental: Paclitaxel IV followed by Carboplatin IV
paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
|Drug: carboplatin Drug: paclitaxel|
- Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin [ Time Frame: baseline to 18 months ]
- Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen [ Time Frame: baseline through 18 months ]
- Determine the tolerability and toxicity of this regimen in these patients. [ Time Frame: baseline to 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096343
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|Principal Investigator:||Lisle M. Nabell, MD||University of Alabama at Birmingham|