Status:
COMPLETED
Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES: * Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast meeting the following stage criteria:
- T2, T3, or T4a-c
- N0-2
- M0
- Inflammatory breast cancer (stage IIIB) allowed
- Measurable disease by mammogram or ultrasound
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Hepatic
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- Renal
- Creatinine ≤ 1.2 times ULN OR
- Creatinine clearance ≥ 50 mL/min
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No comorbid medical condition that would preclude study participation
- No comorbid infection that would preclude study participation
- No clinically significant peripheral neuropathy (\> grade 1)
- No prior significant allergic reaction to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K
- No dementia or altered mental status that would prohibit understanding of informed consent
- No other primary malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent prophylactic growth factors
- Chemotherapy
- No prior chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- At least 3 weeks since prior surgery
- Other
- No other concurrent anticancer drugs
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00096343
Start Date
October 1 2002
End Date
March 1 2005
Last Update
December 4 2018
Active Locations (1)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300