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Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: September 10, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: Jonsson Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068341
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Biological: trastuzumab
Drug: carboplatin
Drug: docetaxel
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Surgery
Drug Information available for: Carboplatin Docetaxel Trastuzumab
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate after completion of neoadjuvant therapy (4 courses) [ Designated as safety issue: No ]
  • Toxicity after completion of neoadjuvant and adjuvant therapies [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease-free survival at 1, 2, and 5 years [ Designated as safety issue: No ]
  • Overall survival at 1, 2, and 5 years [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: July 2003
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I (neoadjuvant therapy): Experimental
Patients receive trastuzumab (concurrently with chemotherapy) IV over 30-90 minutes on days 1, 8, and 15. Trastuzumab repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Biological: trastuzumab
Given IV
Drug: carboplatin
Given IV
Drug: docetaxel
Given IV
Arm II (neoadjuvant therapy): Active Comparator
Patients do not receive concurrent trastuzumab. Patients receive neoadjuvant chemotherapy only.
Drug: carboplatin
Given IV
Drug: docetaxel
Given IV

Detailed Description:

OBJECTIVES:

  • Compare the objective response rate of women with locally advanced breast cancer treated with neoadjuvant docetaxel and carboplatin with vs without trastuzumab (Herceptin®).
  • Compare the toxic effects of these regimens in these patients.
  • Compare disease-free and overall survival in patients treated with these regimens.
  • Determine the molecular characteristics of tumors that are responsible for drug susceptibility and drug interactions in patients treated with these regimens.
  • Provide additional prognostic information about these patients for conventional pathology studies.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, initial tumor size, tumor type (T_2 vs T_3 vs T_4), presence of clinically positive lymph nodes (yes vs no), and mother's family history (positive vs negative).

  • Neoadjuvant therapy: All patients receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1 or 2. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who are HER2/neu positive are randomized to 1 of 2 concurrent trastuzumab (Herceptin®) treatment arms.

    • Arm I: Patients receive trastuzumab (concurrently with chemotherapy) IV over 30-90 minutes on days 1, 8, and 15. Trastuzumab repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    • Arm II: Patients do not receive concurrent trastuzumab. Patients receive neoadjuvant chemotherapy only.
  • Surgery: Within 3 weeks after completion of course 4 of neoadjuvant therapy, patients with responding disease undergo definitive surgery.
  • Adjuvant therapy: Within 4-6 weeks after surgery, patients with responding disease receive 4 additional courses of docetaxel and carboplatin as during neoadjuvant chemotherapy. All HER2/neu positive patients also receive trastuzumab IV once weekly for 12 weeks and then every 3 weeks for 40 weeks (total of 52 weeks of trastuzumab therapy).

Within 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy.

Estrogen-receptor positive patients receive oral tamoxifen once daily for 5 years.

Patients are followed annually for 5 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 4 years.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed infiltrating adenocarcinoma of the breast

    • Primary disease greater than 2 cm (T_2, T_3) OR skin and chest wall involvement (T_4)
    • Any N
    • No evidence of metastasis (M0)
    • Diagnosed within the past 3 months
  • HER2/neu status determined by fluorescent in situ hybridization

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 to 80

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 1 year

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic

  • Bilirubin ≤ upper limit of normal (ULN)
  • SGOT and SGPT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN

Renal

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • LVEF normal by MUGA or echocardiogram

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergy to polysorbate or castor oil
  • No ongoing active infection
  • No concurrent life-limiting disease
  • No other malignancy within the past 5 years that could affect the diagnosis or assessment of breast cancer, except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No grade 2 or greater pre-existing peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior trastuzumab (Herceptin®)
  • No other prior or concurrent immunotherapy
  • No prior or concurrent gene therapy

Chemotherapy

  • No prior docetaxel
  • No prior carboplatin
  • No other prior or concurrent chemotherapy

Endocrine therapy

  • No prior or concurrent antitumor hormonal therapy

Radiotherapy

  • No prior radiotherapy to the involved breast
  • No concurrent radiotherapy to an indicator lesion

Surgery

  • Not specified

Other

  • More than 5 years since any prior drug therapy for breast cancer
  • No other concurrent experimental drugs
  • No other concurrent anticancer treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068341

Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Wilshire Oncology Medical Group, Incorporated - Pomona
Pomona, California, United States, 91767-3021
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Helena R. Chang, MD, PhD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center at UCLA ( Helena R. Chang )
Study ID Numbers: CDR0000321924, UCLA-9911084, AVENTIS-GIA-11156, GENENTECH-H2269s
Study First Received: September 10, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00068341     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
 Trastuzumab
Breast Neoplasms
Carboplatin
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on November 22, 2009



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