A prospective study comparing sequential versus concomitant radiotherapy boost in breast conservative therapy.

This study is a prospective randomized non-inferiority trial of accelerated hypofractionated whole breast irradiation plus sequential boost versus concomitant boost after breast conservative surgery. It will be conducted on 124 patients who will be randomized using permuted blocks. The primary outcome measured is the cosmetic outcome, while secondary outcomes are patient satisfaction (using breast questionnaire), acute toxicity (using RTOG acute toxicity scoring criteria), and late toxicity (using RTOG late toxicity scoring criteria).

Inclusion Criteria:

• Histopathologically proven breast cancer resected by lumpectomy

• Female patient

• Invasive breast cancer

• Negative surgical margin

• Age < or equal 50 years, or high-grade irrespective of age

• Appropriate stage for protocol entry i.e. no metastasis

• Performance Status 0-2

• Hormone receptor status:

  1. ER/PR Known
  2. Borderline results are considered positive

Exclusion Criteria:

• Metastatic patients
• Paget's disease of nipple
• Non-epithelial breast malignancy e.g. sarcoma, lymphoma
• Unresected suspicious microcalcifications in the same or contralateral breast
• Pregnant women
• Inability to delineate lumpectomy cavity
• Psychiatric or addictive disorders rendering treatment or follow-up difficult