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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trans Tasman Radiation Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peter MacCallum Cancer Centre, Australia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2007

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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