Trial Outcomes & Findings for Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer (NCT NCT01928680)

Results Overview

Recruitment status

UNKNOWN

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

6 months

Results posted on

2015-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Cisplatin/Capecitabine Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity. This is a single arm phase II clinical trial. Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity
Overall Study STARTED	33
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Capecitabine and Cisplatin to Treat Metastatic Triple Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cisplatin/Capecitabine n=33 Participants Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity. This is a single arm phase II clinical trial. Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment China	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Cisplatin/Capecitabine n=33 Participants Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity. This is a single arm phase II clinical trial. Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity
Overall Response Rate	63.6 percentage of response

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.

Outcome measures

Outcome data not reported

Adverse Events

Cisplatin/Capecitabine

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cisplatin/Capecitabine n=33 participants at risk Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity. This is a single arm phase II clinical trial. Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity
Blood and lymphatic system disorders leukopenia	81.8% 27/33 • 1year

Additional Information

Dr. Qiao Li

Chinese Academy of Medical Science

Phone: 86-18500027849

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place