Randomized Boost Versus no Boost Irradiation of Early Breast Cancer
Randomized Boost Versus no Boost Irradiation of Early Breast Cancer
Radiation therapy may kill any tumor cells remaining after surgery. This randomized phase III
 trial is studying the effect of an extra dose of radiation therapy (Boost dose) after breast
 conserving surgery and 50 Gy adjuvant external beam radiotherapy to see how well it works
 compared to no further therapy in treating women with early breast cancer that has been
 surgically removed.
This is a randomized study. Patients are stratified by participating institution, menopausal
 status, clinical tumor size, nodal status, presence of Ductal Carcinoma In Situ, age, and
 resection margin status.

 The objective of this trial is to assess the local recurrence rate and the cosmetic result in
 women who have had conservative resection of small breast cancers and who are randomly
 assigned after postoperative whole-breast irradiation to no boost vs. 15-16 Gy boost
 (patients with microscopically complete resections) or 10 Gy vs. 25-26 Gy boost (patients
 with microscopically incomplete resections).

 Following tumorectomy, all patients receive radiotherapy for 5 weeks.

 Patients with microscopically negative resection margins are randomized to one of 2 groups:
 no further radiotherapy; or a radiotherapy boost with either external-beam radiotherapy or an
 interstitial implant.

 Patients with microscopically positive resection margins are also randomized to receive
 either lower dose or higher dose radiotherapy boosts by external beam or interstitial
 implant.

 Patients with positive lymph nodes are encouraged to receive at least 6 courses of adjuvant
 or perioperative chemotherapy prior to radiotherapy provided radiotherapy is initiated within
 6 months of surgery. All other patients begin radiotherapy within 9 weeks of surgery. All
 postmenopausal women with positive lymph nodes receive oral tamoxifen daily for 2 years.
Inclusion Criteria:

 -  Histologically documented invasive adenocarcinoma (any subtype) of the breast with
 clinical stage T1-2 (0-5 cm) and pathologic stage N0-1, M0 disease

 -  Lumpectomy with 1-2 cm margin required within 9 weeks of initiation of protocol
 radiotherapy

 -  Axillary dissection required for premenopausal patients and recommended for
 postmenopausal patients (Irradiation of clinically negative axilla is an acceptable
 alternative to axillary dissection in postmenopausal patients)

 Exclusion Criteria:

 -  Residual microcalcification on postoperative mammogram

 -  Gross residual disease in the breast (re-excision allowed if there is gross residual
 disease after first surgical procedure)

 -  Multiple foci of tumor in more than 1 quadrant

 -  Previous or concurrent malignant tumor in contralateral breast

 -  In situ carcinoma of the breast, without invasive tumor

 -  Tumorectomy performed more than 9 weeks before the start of radiotherapy in cases
 where no adjuvant chemotherapy is given and more than 6 months before the start of
 radiotherapy if chemotherapy is given

 -  Previous history of malignant disease, except adequately treated carcinoma in situ of
 the cervix or basal cell carcinoma of the skin

 -  Concurrent pregnancy or lactation

 -  Eastern Cooperative Oncology Group performance scale more than 2