Status:
COMPLETED
Accelerated Partial Breast Irradiation for Early Breast Cancer
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Peter MacCallum Cancer Centre, Australia
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
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 th...
Detailed Description
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 feas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00418210
Start Date
August 1 2007
End Date
August 20 2018
Last Update
December 5 2019
Active Locations (7)
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1
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
2
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2069
3
Princess Alexandra Hospital
Wooloongabba, Queensland, Australia, 4102
4
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 8006