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NCT01143974 Clinical Trial

Trial of Pemetrexed in Combined With Cisplatin for the Treatment of Advanced Breast Cancer

Locally Advanced Malignant Neoplasm Clinical Trial

Official title:
Trial of Pemetrexed in Combined With Cisplatin for the Treatment of Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01143974
Other study ID # CH-BC-008
Secondary ID
Status Completed
Phase Phase 4
First received June 14, 2010
Last updated March 13, 2013
Start date June 2010
Est. completion date June 2012

Study information
Verified date March 2013
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

For patients resistant to enthrycycline and taxanes, there is no standard regimen. Pemetrexed alone had certain efficacy in treatment of advance breast cancer. Platin was also a effective drug for advanced breast cancer. The combination of these two drug may have a synergy with each other in treatment of advanced breast cancer.

Description:

combination of pemetrexed and cisplatin to treat advanced breast cancer. Previous regimen no more than 3 which including enthrycycline and taxanes(paclitaxel and/or docetaxel)

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 18-70 years old

- Resistant to enthracycle and taxanes

- Has measurable disease

Exclusion Criteria:

- Has more than 3 previous chemotherapy regimens

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• pemetrexed plus cisplatin
pemetrexed 500mg/m2 plus cisplatin 80mg/m2 on day1 of each 21 day cycle, until progression

Locations
Country Name City State
China Cancer Institute & Hospital. Chinese Academy of Medical Sciences Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS (progression free survival) 2 Years Yes
Secondary Safety Assessing for Hematology and Non-hematology toxicities, including all SAEs. 2 years Yes
Secondary Response Rate 2 years Yes
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