A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer
OBJECTIVES:
- 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Lisle M. Nabell, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Alabama at Birmingham
Authority:
United States: Federal Government
Study ID:
CDR0000377728
NCT ID:
NCT00096343
Start Date:
October 2002
Completion Date:
Related Keywords:
- Breast Cancer
- invasive ductal breast carcinoma
- invasive lobular breast carcinoma
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- inflammatory breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
