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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003893
First Posted: January 27, 2003
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00003893     History of Changes
Other Study ID Numbers: CDR0000067062
CRC-TU-BR3015
EU-99005
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: December 19, 2013
Last Verified: November 2001

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
Cyclophosphamide
Methotrexate
Fluorouracil
Mitomycin
Liposomal doxorubicin
Doxorubicin
Epirubicin
Mitoxantrone
Mitomycins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents