Trial Outcomes & Findings for Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer (NCT NCT00438100)
NCT ID: NCT00438100
Last Updated: 2015-05-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
142 participants
Primary outcome timeframe
The follow up period will be two years after the last dose has been administered.
Results posted on
2015-05-29
Participant Flow
Participant milestones
| Measure |
Capecitabine Arm
Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
|
S-1 Arm
S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
69
|
|
Overall Study
COMPLETED
|
71
|
65
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
Baseline characteristics by cohort
| Measure |
Capecitabine Arm
n=71 Participants
Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
|
S-1 Arm
n=65 Participants
S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The follow up period will be two years after the last dose has been administered.Outcome measures
| Measure |
Capecitabine Arm
n=71 Participants
Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
|
S-1 Arm
n=65 Participants
S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
|
|---|---|---|
|
Progression Free Survival
|
1.2 years
Interval 0.76 to 2.04
|
1.3 years
Interval 0.96 to 2.68
|
SECONDARY outcome
Timeframe: The follow up period will be two years after the last dose has been administered.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The follow up period will be two years after the last dose has been administered.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The follow up period will be two years after the last dose has been administered.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The follow up period will be two years after the last dose has been administered.Outcome measures
Outcome data not reported
Adverse Events
Capecitabine Arm
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
S-1 Arm
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Capecitabine Arm
n=71 participants at risk
Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
|
S-1 Arm
n=65 participants at risk
S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
|
|---|---|---|
|
Investigations
Thrombocytopenia
|
1.4%
1/71
|
9.2%
6/65
|
|
Gastrointestinal disorders
Nausea
|
14.1%
10/71
|
26.2%
17/65
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
25.4%
18/71
|
10.8%
7/65
|
|
Blood and lymphatic system disorders
Anaemia
|
9.9%
7/71
|
12.3%
8/65
|
|
Investigations
Leukopenia
|
8.5%
6/71
|
15.4%
10/65
|
|
Investigations
Neutropenia
|
9.9%
7/71
|
7.7%
5/65
|
|
Metabolism and nutrition disorders
Anorexia
|
14.1%
10/71
|
18.5%
12/65
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
4/71
|
6.2%
4/65
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
5/71
|
4.6%
3/65
|
|
Gastrointestinal disorders
Stomatitis
|
4.2%
3/71
|
9.2%
6/65
|
|
Congenital, familial and genetic disorders
Diarrhea
|
8.5%
6/71
|
16.9%
11/65
|
|
Investigations
Transaminase
|
4.2%
3/71
|
9.2%
6/65
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place