Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer

NCT ID: NCT00096343

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2005-03-31

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 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.

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 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Interventions

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Lisle Nabell

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisle M. Nabell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB-0137

Identifier Type: -

Identifier Source: secondary_id

CDR0000377728

Identifier Type: -

Identifier Source: org_study_id