A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.
A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.
Hypothesis:
In selected women with node-negative invasive breast cancer treated with breast conserving surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local control rate in a multicentre trial.
This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with node-negative breast cancer treated by breast conserving surgery with negative margins.
This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT. This is defined as the proportion of eligible patients treated without a major protocol deviation. Secondary endpoints include radiation toxicity, cosmetic outcome, quality of life, time to ipsilateral breast recurrence, disease-free survival, and overall survival.
Primary objectives: To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery.
Secondary objectives:
Inclusion Criteria:
Patients must fulfill all of the following criteria for admission to study:
Women aged >= 50 years.
Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.
Bilateral mammograms performed within 6 months prior to registration.
Treated with breast conserving surgery (primary excision or re-excision) with negative radial resection margins of >= 2 mm* for both the invasive and if present, associated intraductal tumour.
*Patients with superficial or deep resection margin of < 2 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.
Unifocal tumour measuring ≤ 20 mm in maximum microscopic dimension.
Negative nodal status determined by sentinel node biopsy, axillary dissection, or for women > 70 years of age, clinical examination.
No evidence of distant metastasis.
Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy.
Ability to tolerate protocol therapy.
Protocol therapy must commence no later than 12 weeks from the last surgical procedure or 8 weeks from the last dose of chemotherapy.
Availability for long-term follow-up.
Women of child-bearing potential must use adequate contraception during RT.
Written informed consent.
Exclusion Criteria:
Patients who fulfill any of the following criteria are not eligible for admission to study:
Wooloongabba, Queensland 4102, Australia