Accelerated Partial Breast Irradiation for Early Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accelerated partial breast irradiation<br>Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT) | Radiation: Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)<br>* Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT; 38.5 Gy in 3.85 Gy fractions bi-daily over 5 consecutive working days<br>* Other names: Radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility rate of APBI using 3D conformal radiation therapy |  | First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation toxicity |  | First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years. | 
| Cosmetic outcome |  | First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial) | 
| Quality of life |  | First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years. | 
| Time to ipsilateral breast recurrence |  | First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years. | 
| Disease free survival |  | First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years. | 
| Overall survival |  | A final analysis will occur when all patients have been followed up for 5 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accelerated Partial Breast Irradiation, Conformal Radiation Therapy, Feasibility, Early breast cancer