Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 12/6/2018 |
| Start Date: | October 2002 |
| End Date: | March 2005 |
A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer
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.
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.
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.
- 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.
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
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