Accelerated Partial Breast Irradiation for Early Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2018-08-20

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Accelerated partial breast irradiation

Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)

Group Type EXPERIMENTAL

Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)

Intervention Type RADIATION

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

Interventions

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Accelerated partial breast irradiation (APBI) to region of tumour bed using 3D conformal radiation therapy (3D CRT)

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

Intervention Type RADIATION

Other Intervention Names

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Radiation

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

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No