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

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.

Sex

Female

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

• BACKGROUNDBowden 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
• BACKGROUNDFernando 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.
• BACKGROUNDFernando 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
• DERIVEDFernando 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
• DERIVEDFernando 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