Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003893
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: November 2001
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumors cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy is more effective for early-stage breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of adjuvant chemotherapy plus radiation therapy in treating women who have early-stage breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: CMF regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: epirubicin hydrochloride
Drug: fluorouracil
Drug: methotrexate
Drug: mitomycin C
Drug: mitoxantrone hydrochloride
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast Cancer

Resource links provided by NLM:


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

Estimated Enrollment: 2250
Study Start Date: July 1998
Study Completion Date: April 2006
Detailed Description:

OBJECTIVES:

  • Compare the effects of synchronous vs sequential adjuvant chemotherapy and radiotherapy on local recurrence, disease-free and overall survival, and treatment delay in women with early-stage breast cancer.
  • Compare the safety of these regimens, in terms of dose intensity and toxicity, in this patient population.
  • Compare the quality of life and cosmetic outcome in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical oncologist, axillary clearance (yes vs no), radiotherapy boost intent (boost vs no boost), and chemotherapy intent (cyclophosphamide, methotrexate, and fluorouracil [5-FU] vs anthracycline-containing regimen). Patients are randomized to one of two treatment arms.

Patients receive any chemotherapy regimen that includes cyclophosphamide, methotrexate, and 5-FU. Some regimens may also include epirubicin, doxorubicin, mitoxantrone, and/or mitomycin. Chemotherapy repeats every 3 weeks for 4-8 courses.

  • Arm I (synchronous chemoradiotherapy): Patients receiving synchronous therapy receive any of the above chemotherapy regimens plus daily radiotherapy between courses 2 and 3 OR courses 5 and 6 of chemotherapy. Radiotherapy is administered for 3-5 weeks.
  • Arm II (sequential chemoradiotherapy): Patients receiving sequential therapy receive any of the above chemotherapy regimens followed by daily radiotherapy beginning after completion of all chemotherapy (after course 6 or 8). Radiotherapy is administered for 3-5 weeks.

Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before chemotherapy, 2-3 weeks after the completion of all treatment, and then at 1, 2, and 5 years.

Patients are followed annually for 10 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 2,250 patients (1,125 per treatment arm) will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer

    • Early-stage disease

      • No metastatic disease
    • Complete surgical excision of tumor
  • Planned use of adjuvant chemotherapy and radiotherapy
  • If participating in the cosmetic outcome evaluation portion of the study, must have unilateral disease
  • Hormone receptor status

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Bone marrow function adequate

Hepatic:

  • Hepatic function adequate

Renal:

  • Renal function adequate

Cardiovascular:

  • Cardiac function adequate

Other:

  • No other prior malignancy except basal cell or squamous cell skin cancer or carcinoma in situ
  • No other medical or social condition that would preclude study compliance
  • Fit to receive both adjuvant chemotherapy and radiotherapy (administered either synchronously or sequentially)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No prior chemotherapy
  • No concurrent epirubicin and doxorubicin as a study combination chemotherapy regimen

Endocrine therapy:

  • Prior or concurrent hormonal therapy allowed
  • No concurrent tamoxifen if treated with methotrexate, mitomycin, and mitoxantrone as a study combination chemotherapy regimen

Radiotherapy:

  • See Disease Characteristics
  • No concurrent internal mammary chain irradiation
  • No concurrent orthovoltage irradiation to the whole breast

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery

Other:

  • Concurrent participation in another clinical trial allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003893

Locations
United Kingdom
Queen Elizabeth Hospital at University of Birmingham
Birmingham, England, United Kingdom, B15 2TH
Sponsors and Collaborators
University Hospital Birmingham
Investigators
Study Chair: Indy Fernando, MD University Hospital Birmingham
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003893     History of Changes
Other Study ID Numbers: CDR0000067062, CRC-TU-BR3015, EU-99005
Study First Received: November 1, 1999
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Mitomycins
Mitomycin
Doxorubicin
Epirubicin
Cyclophosphamide
Fluorouracil
Methotrexate
Mitoxantrone
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on April 14, 2014