Trial Outcomes & Findings for Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer (NCT NCT01417286)

NCT ID: NCT01417286

Last Updated: 2023-04-20

Results Overview

Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 69 participants
• Primary outcome timeframe: Up to 5 years after dose of last treatment, an average of 62 months
• Results posted on: 2023-04-20

Participant Flow

Patients enrolled at the Rutgers Cancer Institute of New Jersey and at the Huntsman Cancer Institute at the University of Utah. After enrolling 69 patients with stage II-III breast cancer, 67 women were eligible for analysis.

Participant milestones

Measure	Radiation Therapy Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days
Overall Study STARTED	67
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer

Baseline characteristics by cohort

Measure	Radiation Therapy n=67 Participants Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=93 Participants
Age, Categorical >=65 years	7 Participants n=93 Participants
Sex: Female, Male Female	67 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	57 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	67 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 5 years after dose of last treatment, an average of 62 months

Assessed by physical examination and other relevant imaging per the discretion of the patients treating physicians. Confirmed by biopsy, and should be coded as either chest wall recurrence, axilla, supraclavicular, or internal mammary.

Outcome measures

Measure	Radiation Therapy n=67 Participants Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days
Number of Participants With Local, Regional, and/or Distant Failure	12 Participants

SECONDARY outcome

Timeframe: weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.

Adverse events will be monitored weekly during treatment, then two weeks after RT, then at week 8, then every 3-6 months for 3 years, then every 6-12 months out to 5 years.

Outcome measures

Measure	Radiation Therapy n=67 Participants Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days
Count of Participants With Grade Three or Higher Toxicities	7 participants

SECONDARY outcome

Timeframe: Up to five years after dose of last treatment, an average of 62 months

Outcome measures

Measure	Radiation Therapy n=43 Participants Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days
Participants With Plans for Breast Reconstruction, Having Grade Three or Higher Reconstruction Complications	15 Participants

Adverse Events

Radiation Therapy

Serious events: 1 serious events

Other events: 67 other events

Deaths: 6 deaths

Serious adverse events

Measure	Radiation Therapy n=67 participants at risk Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days
Infections and infestations Infection	1.5% 1/67 • Number of events 1 • Up to five years after dose of last treatment, an average of 62 months

Other adverse events

Measure	Radiation Therapy n=67 participants at risk Patients undergo hypofractionated accelerated radiation therapy over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. External beam radiation therapy: Hypofractionated accelerated radiation therapy over 11 days
Skin and subcutaneous tissue disorders Dermatology/Skin	56.7% 38/67 • Number of events 56 • Up to five years after dose of last treatment, an average of 62 months
General disorders Constitutional Symptoms	52.2% 35/67 • Number of events 61 • Up to five years after dose of last treatment, an average of 62 months
General disorders Pain	46.3% 31/67 • Number of events 83 • Up to five years after dose of last treatment, an average of 62 months
Nervous system disorders Neurology	23.9% 16/67 • Number of events 20 • Up to five years after dose of last treatment, an average of 62 months

Additional Information

Dr. Haffty

Cancer Institute of New Jersey Rutgers

Phone: 732-235-8675

Email: hafftybg@cinj.rutgers.edu

Results disclosure agreements

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