NCT02681107

Brief Summary

This study will test the safety of partial breast RT using 27Gy in 5 daily fractions which is expected to be equally tolerated as standard whole breast irradiation (WBI) based on radiobiologic modeling of the fibrosis response of normal tissues but be more convenient and less costly than 3-6 weeks of standard WBI. 274 women will be treated. Rates of fibrosis and cosmesis at 2 years will be compared to data already collected using standard WBI in the Canadian RAPID trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
274

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

5.2 years

First QC Date

February 10, 2016

Last Update Submit

February 19, 2019

Conditions

Breast Cancer

Keywords

Radiation therapyAccelerated partial breast irradiation (APBI)Breast conserving surgeryStage 1

Outcome Measures

Primary Outcomes (1)

  • Rate of Excellent or Good Global cosmetic score

    Global cosmetic score assessed by trained observers and patients themselves using the European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer rating system for cosmetic assessment; rate of deterioration from Excellent/Good to Fair Poor. This will be augmented by assessment of clinical photographs prior to and at 1 and 2 years after radiation therapy (RT).

    2 years

Secondary Outcomes (3)

  • Breast induration

    2 years

  • Breast pain

    2 years

  • Local recurrence

    2 and 5 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Single cohort to receive Accelerated Partial Breast Irradiation (APBI) 27Gy in 5 fractions

Radiation: APBI 27Gy in 5 fractions

Interventions

APBI 27Gy in 5 fractionsRADIATION

Patients will be treated with 3-D conformal, external beam, partial breast RT to deliver 27 Gy in 5 daily fractions using 3-5 beams on a linear accelerator. The target PTV will be the CT-visible seroma plus a 1cm margin to form the CTV (minus 5mm from skin and excluding chest wall) and a further 7mm to form the PTV. Real time review will ensure compliance with target and normal tissues dose constraints in this multi-institutional study. Any (or no) systemic therapy is permitted.

Single Arm

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, with new invasive or in-situ ductal carcinoma of the breast
  • Treated with Breast conserving surgery (BCS) with negative margins
  • pN0 on sentinel node biopsy or axillary dissection; cN0 if DCIS alone
  • Maximum pathologic tumor diameter is 3.0 cm (invasive or DCIS)
  • No clinical or imaging evidence of distant metastases
  • Age 50 years or older at diagnosis
  • No contraindications to breast irradiation
  • Excellent or Good overall cosmetic score at baseline following BCS
  • Able and willing to provide written informed consent
  • Available for 2 year follow up at the treating RT centre

You may not qualify if:

  • Age \< 50 years at diagnosis
  • BRCA 1 or 2 pathogenic mutation
  • Pathologic tumor diameter \>3cm (including DCIS+invasive disease)
  • Lobular histology alone
  • Triple negative (ER-, PR-, HER2-) or HER2 overexpressing disease
  • Margin (other than deep) \<2 mm
  • Presence of both Grade 3 and lymphatic or vascular invasion
  • Fair or Poor overall cosmetic score at baseline following BCS
  • Presence of ipsilateral breast implants
  • Inability to develop an APBI plan meeting all dosimetry constraints
  • Unable to start RT within 16 weeks of BCS or 8 weeks of last iv chemotherapy
  • Unable or unwilling to sign informed consent document or attend for 2-year cosmetic assessment at the treating RT centre
  • Potential contraindications for breast RT including a confirmed diagnosis of lupus, scleroderma, or pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

RECRUITING

Related Publications (1)

  • Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.

    PMID: 23835717BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Petra Grendarova, MD

    Tom Baker Cancer Centre, Alberta Health Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Grendarova, MD

CONTACT

403-521-3105petra.grendarova@ahs.ca

Mark Lesiuk, BSc

CONTACT

Mark.Lesiuk@ahs.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Phase 2 - Irradiation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 12, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

February 21, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

At least one peer-review publication will be prepared by the investigators following the conclusion of the study. In addition, an abstract to report interim results following the 1-year, interim cosmetic evaluation may be submitted to the annual Canadian Association of Radiation Oncology and/or San Antonio Breast Cancer Symposium scientific meetings. Authorship will include the named investigators involved in the development of the grant proposal plus additional authors proportional to subject accrual, participation in the cosmetic photograph review panels and/or other contributions to study analysis or success.

Locations

CA(1)