Trial Outcomes & Findings for Accelerated Hypofractionated Radiotherapy (AHF-RT) for the Treatment of Breast Cancer (NCT NCT01278212)

NCT ID: NCT01278212

Last Updated: 2024-02-22

Results Overview

Both invasive and non-invasive IBTRs will be considered in calculating the primary endpoint.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 158 participants
• Primary outcome timeframe: at 5 years post completion of AHF-RT
• Results posted on: 2024-02-22

Participant Flow

Recruitment 2011-2016, recruitment now complete

Participant milestones

Measure	AHF-RT With Chemotherapy If chemotherapy indicated: accelerated hypofractionated radiotherapy (AHF-RT) 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy accelerated hypofractionated radiotherapy (AHF-RT): 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy
Overall Study STARTED	158
Overall Study COMPLETED	158
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accelerated Hypofractionated Radiotherapy (AHF-RT) for the Treatment of Breast Cancer

Baseline characteristics by cohort

Measure	AHF-RT n=158 Participants accelerated hypofractionated radiotherapy (AHF-RT) 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy accelerated hypofractionated radiotherapy (AHF-RT): 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	158 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	34 Participants n=5 Participants
Race (NIH/OMB) White	124 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	158 participants n=5 Participants
Tumor Subtypes invasive ductal carcinoma	102 Participants n=5 Participants
Tumor Subtypes invasive lobular carcinoma	16 Participants n=5 Participants
Tumor Subtypes ductal carcinoma in situ	35 Participants n=5 Participants
Tumor Subtypes other less common types of carcinoma	5 Participants n=5 Participants
tumor grade Grade 1	33 Participants n=5 Participants
tumor grade Grade 2	67 Participants n=5 Participants
tumor grade Grade 3 worst outcome	58 Participants n=5 Participants
stage Stage 0	36 Participants n=5 Participants
stage stage 1	89 Participants n=5 Participants
stage stage 2	33 Participants n=5 Participants
stage stage 3	0 Participants n=5 Participants
Estrogen receptor status + Estrogen receptor	130 Participants n=5 Participants
Estrogen receptor status - Estrogen receptor	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: at 5 years post completion of AHF-RT

Both invasive and non-invasive IBTRs will be considered in calculating the primary endpoint.

Outcome measures

Measure	AHF-RT n=158 Participants accelerated hypofractionated radiotherapy (AHF-RT) 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy accelerated hypofractionated radiotherapy (AHF-RT): 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy
Ipsilateral Breast Tumor Recurrence (IBTR)	2.7 percentage of participants

Adverse Events

AHF-RT

Serious events: 20 serious events

Other events: 0 other events

Deaths: 17 deaths

Serious adverse events

Measure	AHF-RT n=158 participants at risk accelerated hypofractionated radiotherapy (AHF-RT) 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy accelerated hypofractionated radiotherapy (AHF-RT): 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy
Reproductive system and breast disorders Breast shrinkage or fibrosis	10.8% 17/158 • median follow up 5.5 years, (range, 0.2-9.9 years) Common Terminology Criteria for Adverse Events version 3.0
Cardiac disorders cardiomyopathy	0.63% 1/158 • median follow up 5.5 years, (range, 0.2-9.9 years) Common Terminology Criteria for Adverse Events version 3.0
Reproductive system and breast disorders Breast pain	1.3% 2/158 • median follow up 5.5 years, (range, 0.2-9.9 years) Common Terminology Criteria for Adverse Events version 3.0

Other adverse events

Adverse event data not reported

Additional Information

Harriet Eldredge-Hindy

Medical University of South Carolin

Phone: 8437926382

Email: eldredge@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place