Recruiting

APBIAPBI: 27Gy in 5 Fractions for Early Breast Cancer

Sponsor:

AHS Cancer Control Alberta

Code:

NCT02681107

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

APBI 27Gy in 5 fractions

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT02681107

Start date

May, 2016

Status verified date

Feb, 2019

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

274 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm

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

Interventions

APBI 27Gy in 5 fractions

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.

Primary outcome measure

Rate of Excellent or Good Global cosmetic score [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Petra Grendarova, MD

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

Mark Lesiuk, BSc

Mark.Lesiuk@ahs.ca

Locations

Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Mark Lesiuk, BScRT MRTT

403-521-3958 Mark.Lesiuk@albertahealthservices.ca

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Feb 21, 2019

Last verified

Feb, 2019

Keywords

Radiation therapy
Accelerated partial breast irradiation (APBI)
Breast conserving surgery
Stage 1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2019-02-21.