Trial Outcomes & Findings for Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer (NCT NCT01289353)

NCT ID: NCT01289353

Last Updated: 2021-01-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 92 participants
• Primary outcome timeframe: 60 days post-RT
• Results posted on: 2021-01-12

Participant Flow

Participant milestones

Measure	ChemoRT Concurrent Carboplatin and Radiotherapy Carboplatin: IV, weekly for 6 weeks, AUC of 2.0 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy
Overall Study STARTED	92
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	ChemoRT Concurrent Carboplatin and Radiotherapy Carboplatin: IV, weekly for 6 weeks, AUC of 2.0 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy
Overall Study Lost to Follow-up	2

Baseline Characteristics

Concurrent Adjuvant Carboplatin and Accelerated Radiotherapy for Triple Negative Breast Cancer

Baseline characteristics by cohort

Measure	ChemoRT n=90 Participants Concurrent Carboplatin and Radiotherapy Carboplatin: IV, weekly for 6 weeks, AUC of 2.0 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy
Age, Continuous	56.83 years STANDARD_DEVIATION 12.33 • n=5 Participants
Sex: Female, Male Female	90 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	5 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	8 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	57 Participants n=5 Participants
Region of Enrollment United States	90 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days post-RT

Outcome measures

Measure	ChemoRT n=90 Participants Concurrent Carboplatin and Radiotherapy Carboplatin: IV, weekly for 6 weeks, AUC of 2.0 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy
Number of Patients Who Developed Grade 2-3 Acute Radiation Dermatitis Within 60 Days Post-RT	8 Participants

SECONDARY outcome

Timeframe: 6 months to 5 year post-RT

Acute Toxicities include all Grade 1 toxicities

Outcome measures

Measure	ChemoRT n=90 Participants Concurrent Carboplatin and Radiotherapy Carboplatin: IV, weekly for 6 weeks, AUC of 2.0 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy
Number of Patients Who Experience Acute Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)	67 Participants

SECONDARY outcome

Timeframe: 6 months to 5 years post-RT

Outcome measures

Measure	ChemoRT n=90 Participants Concurrent Carboplatin and Radiotherapy Carboplatin: IV, weekly for 6 weeks, AUC of 2.0 3D-RT or IMRT: From week 2 to week 4 in the 6-week Carboplatin treatment: Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy
Number of Patients Who Experience Grade 2 or Higher Late Toxicities at or More Than 6 Months After Completion of Radiation Treatment (RT)	18 Participants

Adverse Events

ChemoRT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carmen Perez, MD, PhD

NYU Langone Health - PCC CTO

Phone: 212-731-5003

Email: carmen.perez@nyulangone.org

Results disclosure agreements

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