Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast Cancer
N/A
N/A
Female
Breast Cancer
Trial Information
Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Indy Fernando, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Birmingham
Authority:
United States: Federal Government
Study ID:
CDR0000067062
NCT ID:
NCT00003893
Start Date:
July 1998
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- Breast Neoplasms
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