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

NCT00003893 | Completed Phase 3

• 3 other identifiers: CDR0000067062CRC-TU-BR3015EU-99005
• Study Type: interventional
• Target: 2,250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer

Interventions

CMF regimen DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

epirubicin hydrochloride DRUG

fluorouracil DRUG

methotrexate DRUG

mitomycin C DRUG

mitoxantrone hydrochloride DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital Birmingham: lead

Study Sites (1)

Queen Elizabeth Hospital at University of Birmingham

Birmingham, England, B15 2TH, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 16605056 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10942332 BACKGROUND

• 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.

  PMID: 37012180 DERIVED

• 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.

  PMID: 31785830 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CMF regimen; Cyclophosphamide; Doxorubicin; Epirubicin; Fluorouracil; Methotrexate; Mitomycin; Mitoxantrone; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Mitomycins; Indolequinones; Quinones; Azirines; Indoles; Anthraquinones; Anthrones; Anthracenes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Indy Fernando, MD

  University Hospital Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: July 1, 1998
• Study Completion: April 1, 2006
• Last Updated: December 19, 2013

Record last verified: 2001-11

Locations

GB (1)