Trial Outcomes & Findings for Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery (NCT NCT03324802)

NCT ID: NCT03324802

Last Updated: 2024-05-02

Results Overview

The complication rate will be reported by arm.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

107 participants

Primary outcome timeframe

24 months

Results posted on

2024-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 (Radiation Therapy, 15 Fractions) Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Overall Study STARTED	54	53
Overall Study COMPLETED	54	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy	Total n=107 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 7.7 • n=5 Participants	62.9 years STANDARD_DEVIATION 9.3 • n=7 Participants	62.8 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	53 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	49 Participants n=7 Participants	99 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	54 participants n=5 Participants	53 participants n=7 Participants	107 participants n=5 Participants
Study breast Left	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Study breast Right	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Bilateral disease Yes	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Bilateral disease No	54 Participants n=5 Participants	52 Participants n=7 Participants	106 Participants n=5 Participants
Multiple lesions Yes	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Multiple lesions No	49 Participants n=5 Participants	41 Participants n=7 Participants	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

The complication rate will be reported by arm.

Outcome measures

Outcome measures
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Complication Rate, Defined as the Percentage of Women Who Develop Grade 3 or Higher Late Adverse Event and/or Deterioration of Cosmesis From Excellent/Good to Fair/Poor or From Fair to Poor	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 year

Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for one year with 95% CIs. Comparison between arms will employ a log-rank test.

Outcome measures

Outcome measures
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Cause-specific Survival	100 percentage of patients 95% CI not able to be calculated since all patients were alive at 1 year	100 percentage of patients 95% CI not able to be calculated since all patients were alive at 1 year

SECONDARY outcome

Timeframe: 1 year

Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Estimates will be given for one year along with 95% CIs. Comparison between arms will employ a log-rank test.

Outcome measures

Outcome measures
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Overall Survival	100 percentage of patients 95% CI not able to be calculated since all patients were alive at 1 year	100 percentage of patients 95% CI not able to be calculated since all patients were alive at 1 year

SECONDARY outcome

Timeframe: 5 years

Distant recurrence defined as metastatic cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer

Outcome measures

Outcome measures
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Number of Patients Experiencing Distant Recurrence	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

The maximum grade for each type of acute (grade 3+) AE will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. The relationship of the adverse event(s) to the study treatment will be taken into consideration. Number of patients experiencing one or more grade 3+ events will be compared between arms using chi-squared tests. Adverse events were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Outcome measures

Outcome measures
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Number of Patients Experiencing Acute (Grade 3+) Adverse Events (AEs)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months

The maximum grade for each type of late AE will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. The relationship of the adverse event(s) to the study treatment will be taken into consideration. Number of patients experiencing one or more grade 3+ late AEs will be compared between arms using chi-squared tests.

Outcome measures

Outcome measures
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Number of Patients Experiencing Grade 3+ Late Adverse Events	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 5 years

Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Median invasive disease-free time will be given along with standard error. Comparison between arms will employ a log-rank test.

Outcome measures

Outcome measures
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Invasive Disease-free	2.9569 years Standard Error 0.0225	3.4743 years Standard Error 0.0298

SECONDARY outcome

Timeframe: 5 years

The cumulative incidence of locoregional recurrence will be estimated using a competing risks method by treatment arm. The competing risks will be distant breast cancer recurrence and death. Comparison between arms will employ Fine-Gray regression. Locoregional recurrence is clinically diagnosed invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast at 5 years.

Outcome measures

Outcome measures
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Percent of Patients With Locoregional Recurrence	2.3 percentage of patients Interval 0.17 to 10.0	5.8 percentage of patients Interval 1.0 to 17.0

SECONDARY outcome

Timeframe: 5 years

Will be estimated with a Kaplan-Meier estimator and curve by treatment arm. Median disease free survival time and standard error will be estimated. Comparison between arms will employ a log-rank test.

Outcome measures

Outcome measures
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 Participants Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Disease-Free Survival	2.9569 years Standard Error 0.0225	3.17 years Standard Error 0.0282

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

The subscales of the Breast Cancer Treatment Outcomes Scale (BCTOS), elements from Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and other patient reported measures such as fatigue, breast pain, breast shape, and arm related morbidity outlined in the appendix will be summarized as the mean +/- standard deviation and median (minimum value, maximum value). Mixed models will be used to estimate changes at fixed time points.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 5 years

Will evaluate fatigue, breast pain, arm function. The values of the cosmesis instruments (patient self-reported and panel-assessed) will be summarized with the frequencies and confidence intervals of fair or poor cosmesis events at baseline, 2 years, and 5 years by treatment arm. Comparisons between arms will employ chi-squared tests.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1 (Radiation Therapy, 15 Fractions)

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions)

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1 (Radiation Therapy, 15 Fractions) n=54 participants at risk Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo standard radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Radiation Therapy: hypofractionated radiation therapy	Arm 2 (Hypofractionated Radiation Therapy, 5 Fractions) n=53 participants at risk Within 12 weeks of breast cancer surgery or adjuvant chemotherapy, patients undergo hypofractionated radiation therapy in 15 daily fractions for 10 days. Quality-of-Life Assessment: Ancillary studies Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Injury, poisoning and procedural complications Dermatitis radiation	79.6% 43/54 • Number of events 48 • 5 years	67.9% 36/53 • Number of events 44 • 5 years
Infections and infestations Device related infection	1.9% 1/54 • Number of events 1 • 5 years	0.00% 0/53 • 5 years
General disorders Edema limbs	5.6% 3/54 • Number of events 6 • 5 years	9.4% 5/53 • Number of events 7 • 5 years
Vascular disorders Lymphedema	35.2% 19/54 • Number of events 42 • 5 years	37.7% 20/53 • Number of events 48 • 5 years
General disorders Pain	48.1% 26/54 • Number of events 56 • 5 years	43.4% 23/53 • Number of events 51 • 5 years
Skin and subcutaneous tissue disorders Skin hyperpigmentation	53.7% 29/54 • Number of events 48 • 5 years	54.7% 29/53 • Number of events 55 • 5 years
Skin and subcutaneous tissue disorders Skin hypopigmentation	7.4% 4/54 • Number of events 8 • 5 years	17.0% 9/53 • Number of events 13 • 5 years
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	22.2% 12/54 • Number of events 20 • 5 years	22.6% 12/53 • Number of events 19 • 5 years
Gastrointestinal disorders Constipation	0.00% 0/54 • 5 years	1.9% 1/53 • Number of events 1 • 5 years
Injury, poisoning and procedural complications Fracture	0.00% 0/54 • 5 years	1.9% 1/53 • Number of events 1 • 5 years
Renal and urinary disorders Hematuria	0.00% 0/54 • 5 years	1.9% 1/53 • Number of events 1 • 5 years
Cardiac disorders Myocardial infarction	0.00% 0/54 • 5 years	1.9% 1/53 • Number of events 1 • 5 years
Nervous system disorders Syncope	0.00% 0/54 • 5 years	1.9% 1/53 • Number of events 1 • 5 years
Cardiac disorders Ventricular tachycardia	0.00% 0/54 • 5 years	1.9% 1/53 • Number of events 1 • 5 years

Additional Information

Carlos E. Vargas, M.D.

Mayo Clinic

Phone: 4803421262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place