Accelerated Partial Breast Irradiation for Early Breast Cancer

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12607000238471
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility rate of APBI using 3D conformal radiation therapy - Proportion of eligible patients treated without a major protocol deviation. <br>Major Deviations: <br>a. Overall treatment time is more than 10 days<br>b. Maximum dose (in a volume of = 2 cm3) to PTV_EVAL is more than 110% of the<br>prescribed dose<br>c. 90% of the prescribed dose covers less than 90% of the PTV_EVAL on DVH<br>d. 85% of the prescribed dose covers less than 99% of the PTV_EVAL<br>e. Maximum dose to critical normal structures is more than 105% of the specified values.[Measured over the whole duration of the study. The outcome is determined at the end of the study which is until all patients have been treated with APBI (from the data coollected over the whole duration of the study). ]