Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer
NCT ID: NCT00003893
Last Updated: 2013-12-19
Study Results
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Basic Information
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COMPLETED
PHASE3
2250 participants
INTERVENTIONAL
1998-07-31
2006-04-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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CMF regimen
cyclophosphamide
doxorubicin hydrochloride
epirubicin hydrochloride
fluorouracil
methotrexate
mitomycin C
mitoxantrone hydrochloride
adjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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University Hospital Birmingham
OTHER
Principal Investigators
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Indy Fernando, MD
Role: STUDY_CHAIR
University Hospital Birmingham
Locations
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Queen Elizabeth Hospital at University of Birmingham
Birmingham, England, United Kingdom
Countries
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References
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Bowden SJ, Fernando IN, Burton A. Delaying radiotherapy for the delivery of adjuvant chemotherapy in the combined modality treatment of early breast cancer: is it disadvantageous and could combined treatment be the answer? Clin Oncol (R Coll Radiol). 2006 Apr;18(3):247-56. doi: 10.1016/j.clon.2005.11.010.
Fernando I, Bowden S, Dunn J: The combination of chemotherapy and radiotherapy in the adjuvant treatment of breast cancer. [Abstract] Radiother Oncol 58 (Suppl 1): A-34, S10, 2001.
Fernando IN. The role of radiotherapy in patients undergoing mastectomy for carcinoma of the breast. Clin Oncol (R Coll Radiol). 2000;12(3):158-65. doi: 10.1053/clon.2000.9143.
Fernando IN, Lax S, Bowden SJ, Ahmed I, Steven JH, Churn M, Brunt AM, Agrawal RK, Canney P, Stevens A, Rea DW. Detailed Sub-study Analysis of the SECRAB Trial: Quality of Life, Cosmesis and Chemotherapy Dose Intensity. Clin Oncol (R Coll Radiol). 2023 Jun;35(6):397-407. doi: 10.1016/j.clon.2023.03.007. Epub 2023 Mar 20.
Fernando IN, Bowden SJ, Herring K, Brookes CL, Ahmed I, Marshall A, Grieve R, Churn M, Spooner D, Latief TN, Agrawal RK, Brunt AM, Stevens A, Goodman A, Canney P, Bishop J, Ritchie D, Dunn J, Poole CJ, Rea DW; SECRAB Investigators. Synchronous versus sequential chemo-radiotherapy in patients with early stage breast cancer (SECRAB): A randomised, phase III, trial. Radiother Oncol. 2020 Jan;142:52-61. doi: 10.1016/j.radonc.2019.10.014. Epub 2019 Nov 27.
Other Identifiers
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CRC-TU-BR3015
Identifier Type: -
Identifier Source: secondary_id
EU-99005
Identifier Type: -
Identifier Source: secondary_id
CDR0000067062
Identifier Type: -
Identifier Source: org_study_id