None listed
Conditions
Brief summary
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: - To assess the acute and long term toxicity of APBI using 3D CRT. - To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT. - To determine the time to ipsilateral breast recurrence, disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT. - To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT
Interventions
Accelerated partial breast irradiation (APBI) to region of tumour bed
3-dimensional conformal radiation therapy (3D CRT) 38.5 Gy in 3.85 Gy fractions over 5 consecutive working days
Sponsors
Trans Tasman Radiation Oncology Group (TROG)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must fulfil 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 fulfil any of the following criteria are not eligible for admission to study:- Multifocal or multicentric tumours.- Clinical or pathologic evidence of any of the following tumour features: extension to chest wall (excluding pectoralis muscle); oedema (including peau d’orange) or ulceration of skin; satellite skin nodules confined to the same breast; and inflammatory carcinoma.- Presence of extensive intraductal component (ductal carcinoma in situ occupying > 25% of the primary invasive tumour and present adjacent to the primary tumour).- Node-positive breast cancer determined by sentinel node biopsy, axillary dissection, or in women > 70 years of age, clinical examination.- Inability to localise surgical cavity on CT scans with no evidence of a surgical cavity, seroma or surgical clips delineating the tumour bed.- Treatment target volume estimated to occupy > 25% of the ipsilateral whole breast volume - Synchronous or metachronous bilateral invasive or intraductal breast cancer.- Locally recurrent breast cancer.- Ipsilateral breast implant.- Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).- Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix or endometrium treated five years prior to study entry.- Women who are pregnant or lactating.- Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
Outcome results
None listed