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

NCT00068341 | Completed Phase 2 Results DMC

• 4 other identifiers: 99-11-084CDR0000321924AVENTIS-GIA-11156GENENTECH-H2269s
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical Tumor Response by Physical Exam and Imaging Studies

  5 years

• Tumor Response Assessment

  5 years

• Clinico-histologic Predictors of pCR (Pathologic Complete Response)

  5 years

• Pathologic Nodal Status

  5 years

Study Arms (3)

Arm I (neoadjuvant therapy)

EXPERIMENTAL

see intervention description

Drug: carboplatin; Drug: docetaxel; Biological: trastuzumab

Arm II (neoadjuvant therapy)

EXPERIMENTAL

please see intervention description

Biological: trastuzumab; Drug: carboplatin; Drug: docetaxel

HER2/neu negative patients

EXPERIMENTAL

please see intervention description

Drug: carboplatin; Drug: docetaxel

Interventions

trastuzumab BIOLOGICAL

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

Also known as: Herceptin

Arm II (neoadjuvant therapy)

carboplatin DRUG

Cycle 1-8 Day 1 or 2 AUC = 6 IV

Arm I (neoadjuvant therapy); Arm II (neoadjuvant therapy); HER2/neu negative patients

docetaxel DRUG

Cycle 1-8 Day 1 or 2: 75 mg/m2 IV

Also known as: Taxotere

Arm I (neoadjuvant therapy); Arm II (neoadjuvant therapy); HER2/neu negative patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Aventis Pharmaceuticals: collaborator
• Genentech, Inc.: collaborator

Study Sites (4)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Wilshire Oncology Medical Group, Incorporated - Pomona

Pomona, California, 91767-3021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Carboplatin; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Helena Chang, M.D., Ph.D., Revlon/UCLA Breast Center
• Organization: Jonsson Comprehensive Cancer Center

hchang@mednet.ucla.edu

310-794-5640

Study Officials

• Helena R. Chang, MD, PhD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: July 1, 2003
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 9, 2020
• Results First Posted: March 27, 2017

Record last verified: 2016-03

Locations

US (4)