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A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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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 CenterBirmingham, Alabama  35294-3300