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

Phase 4

Completed

• Conditions: Locally Advanced Malignant Neoplasm
• Interventions: Drug: pemetrexed plus cisplatin

• Registration Number: NCT01143974
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-14
• Study First Posted: 2010-06-15
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PC Regimen	pemetrexed plus cisplatin	-

Primary Outcome Measures

Name	Time	Method
PFS (progression free survival)	2 Years

Secondary Outcome Measures

Name	Time	Method
Safety	2 years	Assessing for Hematology and Non-hematology toxicities, including all SAEs.
Response Rate	2 years

Trial Locations

Locations (1)

Cancer Institute & Hospital. Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China