Trial Outcomes & Findings for Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery (NCT NCT00562718)

NCT ID: NCT00562718

Last Updated: 2020-08-21

Results Overview

Primarily Grade 1 and 2 toxicities attributable to capecitabine

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

1 year

Results posted on

2020-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Surgery and Chemotherapy Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria. capecitabine adjuvant therapy radiation therapy
Overall Study STARTED	50
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Surgery and Chemotherapy Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria. capecitabine adjuvant therapy radiation therapy
Overall Study Death	1
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	4
Overall Study Lack of Efficacy	2
Overall Study not stated	1

Baseline Characteristics

Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgery and Chemotherapy n=39 Participants Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria. capecitabine adjuvant therapy radiation therapy
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	52 years n=99 Participants
Sex: Female, Male Female	39 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	12 Participants n=99 Participants
Race (NIH/OMB) White	23 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	39 Participants n=99 Participants
masectomy	6 Participants n=99 Participants
partial masectomy	22 Participants n=99 Participants
neo-adjuvant	14 Participants n=99 Participants
adjuvant	28 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Radiation given based on planned- 50.4cGy

Primarily Grade 1 and 2 toxicities attributable to capecitabine

Outcome measures

Outcome measures
Measure	Surgery and Chemotherapy n=28 Participants Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria. capecitabine adjuvant therapy radiation therapy
Overall Safety	12.6 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Surgery and Chemotherapy n=26 Participants Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria. capecitabine adjuvant therapy radiation therapy
Cosmesis	22 participants

SECONDARY outcome

Timeframe: 1 year

This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy

Outcome measures

Outcome measures
Measure	Surgery and Chemotherapy n=28 Participants Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria. capecitabine adjuvant therapy radiation therapy
Recurrence	14 percentage of participants

Adverse Events

Surgery and Chemotherapy

Serious events: 6 serious events

Other events: 8 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Surgery and Chemotherapy n=39 participants at risk Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria. capecitabine adjuvant therapy radiation therapy
Reproductive system and breast disorders Radiation Dermatitis	15.4% 6/39 • Number of events 6

Other adverse events

Other adverse events
Measure	Surgery and Chemotherapy n=39 participants at risk Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria. capecitabine adjuvant therapy radiation therapy
Gastrointestinal disorders Diarrhea	20.5% 8/39 • Number of events 10

Additional Information

ann spangler

UT Southwestern Medical Center

Phone: (214) 648-3111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place