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Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
This study has been completed.
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016276
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy combined with surgery and radiation therapy is more effective with or without dexrazoxane and trastuzumab in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have stage IIIA, stage IIIB or stage IV breast cancer.


Condition Intervention Phase
Breast Cancer
Cancer-Related Problem/Condition
Drug: cyclophosphamide
Drug: dexrazoxane hydrochloride
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: trastuzumab
Procedure: conventional surgery
Procedure: radiation therapy
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Paclitaxel Trastuzumab Dexrazoxane Dexrazoxane hydrochloride ICRF 159 Razoxane
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A 2X2X2 Factorial Randomized Phase III Trial Of Multimodality Therapy Comparing 4 Cycles Of Doxorubicin And Cyclophosphamide With Or Without Dexrazoxane (AC+/-Z) Followed By 12 Weeks Of Weekly Paclitaxel With Or Without Trastuzumab (T+/-H) Followed By Local Therapy Followed By 40 Weeks Of Weekly Trastuzumab Or None In Women With HER-2+ Stage IV Breast Cancer

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

Study Start Date: May 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary infiltrating adenocarcinoma of the breast

    • Confirmed by core needle biopsy or incisional biopsy
    • Amplification of HER-2 by FISH OR
    • Overexpression (3+) of HER-2 by immunohistochemistry
    • Staging criteria after complete clinical and radiographic staging:

      • T3, N1, M0 OR
      • Any T, N2 or N3, M0 OR
      • T4, any N, M0, including clinical or pathological inflammatory disease OR
      • Regional stage IV disease with supraclavicular or infraclavicular lymph nodes as only site of metastasis
  • Measurable or evaluable disease
  • Prior ductal carcinoma in situ of the ipsilateral breast allowed if treated with excision only without mastectomy or radiation
  • Metaplastic carcinoma allowed
  • Synchronous bilateral primary disease allowed (provided at least 1 cancer meets staging criteria)
  • No dermal lymphatic involvement with clinical inflammatory changes
  • Hormone receptor status:

    • Estrogen receptor positive or negative
    • Progesterone receptor positive or negative

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,000/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • LVEF normal by MUGA
  • No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)

Other:

  • No other currently active malignancy except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Patients taking tamoxifen must use effective nonhormonal contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • No more than 4 weeks of prior tamoxifen for disease
  • Prior tamoxifen or raloxifene for longer than 4 weeks as chemoprevention allowed
  • No concurrent tamoxifen or raloxifene
  • No other concurrent hormonal therapy except for steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for index malignancy
  • No prior radiotherapy to the ipsilateral breast, regional nodes, mediastinum, or heart
  • Prior radiotherapy to the contralateral breast for ductal carcinoma in situ or early stage invasive breast cancer allowed provided earlier radiotherapy does not preclude optimal delivery of study radiotherapy and criterion of low risk for metastasis from first malignancy is met

Surgery:

  • See Disease Characteristics
  • No prior sentinel lymph node biopsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016276

  Show 52 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Mark L. Graham, MD UNC Lineberger Comprehensive Cancer Center
  More Information

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

Study ID Numbers: CDR0000068617, CLB-49808
Study First Received: May 6, 2001
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00016276  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
inflammatory breast cancer
cardiac toxicity

Study placed in the following topic categories:
Inflammatory breast cancer
Skin Diseases
Paclitaxel
Trastuzumab
Breast Neoplasms
Cyclophosphamide
Doxorubicin
Breast Diseases
Razoxane

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Cardiovascular Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Chelating Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009