Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068341
• Other study ID #: 99-11-084
• Secondary ID: CDR0000321924AVE
• Status: Completed
• Phase: Phase 2
• Start date: July 2003
• Est. completion date: November 2013

Study information

• Verified date: March 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Confirmed infiltrating adenocarcinoma of the breast

• Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence of metastasis.

• No prior radiation to the involved breast

• ECOG (Electrocochleography) performance status 0-2

• Age 18 years to 80 years

• Absolute Neutrophil count > 1500 cell/µl, platelet count > 100000 cells/µl and hemoglobin > 9 g/dl

• All liver function tests < upper limit of normal

• Serum creatinine < 2.0 mg/dl

• Normal left ventricular ejection fraction (LVEF) as determined by MUGA (Multiple Gated Acquisition) scan or echocardiogram

• HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) test. [FISH (+) is HER-2/neu (+)]

• If female of childbearing potential, pregnancy test is negative

• If premenopausal and not surgically sterilized, the patient agrees to use effective birth control method for the duration of the study

• Informed consent has been obtained

Exclusion Criteria:

• Non-confirmed infiltrating adenocarcinoma breast cancer

• Evidence of metastasis

• Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®, Taxotere®, and/or Carboplatin

• Prior radiation to the involved breast

• Recent breast cancer drug therapy within last 5 years of any form

• History of allergy to polysorbate or castor oil

• Ongoing active infection

• Concurrent life-limiting disease with a life expectancy of less than one year

• Past or current history of other malignancy within the past 5 years which could affect the diagnosis or assessment of breast cancer, except for curatively treated non-melanoma skin cancer and/or in situ carcinoma of the cervix

• Pregnancy, nursing, fertile women who do not use birth control device

• Inability to give informed consent

• Patients with pre-existing peripheral neuropathy > grade 2

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• trastuzumab
Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV

Drug:
• carboplatin
Cycle 1-8 Day 1 or 2 AUC = 6 IV
• docetaxel
Cycle 1-8 Day 1 or 2: 75 mg/m2 IV

Biological:
• trastuzumab
Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV

Locations

Country	Name	City	State
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Wilshire Oncology Medical Group, Incorporated - Pomona	Pomona	California

Sponsors (3)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Aventis Pharmaceuticals, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.	Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR).; Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) & disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen.	5 years
Secondary	Clinical Tumor Response by Physical Exam and Imaging Studies		5 years
Secondary	Tumor Response Assessment	Measured by physical examination compared to breast mammography and MRI assessment	5 years
Secondary	Clinico-histologic Predictors of pCR (Pathologic Complete Response)		5 years
Secondary	Pathologic Nodal Status	According to Primary Tumor Response Pathologic lymph node status N0 Axillary and other nearby lymph nodes do not have cancer (when looked at under a microscope) N1 Micrometastases (very small clusters of cancer) OR 1-3 axillary lymph nodes have cancer AND/OR Internal mammary nodes have tiny amounts of cancer found on sentinel node biopsy N2 4-9 axillary lymph nodes have cancer OR Internal mammary nodes have cancer, but axillary lymph nodes do not have cancer N3 10 or more axillary lymph nodes have cancer OR Infraclavicular (under the clavicle) nodes have cancer OR Internal mammary nodes have cancer plus 1 or more axillary lymph nodes have cancer OR 4 or more axillary lymph nodes have cancer plus internal mammary nodes have cancer or micrometastases found on sentinel node biopsy OR Supraclavicular (above the clavicle) nodes have cancer	5 years