Accelerated Partial Breast Irradiation for Early Breast Cancer

December 3, 2019 updated by: Trans Tasman Radiation Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Sydney, New South Wales, Australia, 2069
        • Royal North Shore Hospital
    • Queensland
      • Wooloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 8006
        • Peter Maccallum Cancer Centre
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Royal Perth Hospital
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland Hospital
      • Hamilton, New Zealand, 3240
        • Waikato Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Accelerated partial breast irradiation
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)
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
Other Names:
  • Radiation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiation toxicity
Time Frame: 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.
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
Time Frame: First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial)
First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial)
Quality of life
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: A final analysis will occur when all patients have been followed up for 5 years.
A final analysis will occur when all patients have been followed up for 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trans Tasman Radiation Oncology Group

Collaborators

Peter MacCallum Cancer Centre, Australia

Investigators

  • Study Chair: Boon Chua, Peter MacCallum Cancer Centre, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

August 20, 2018

Study Registration Dates

First Submitted

January 2, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (ESTIMATE)

January 4, 2007

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TROG 06.02
  • ACTRN12607000238471 (REGISTRY: ANZ CTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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