Phase Ⅱ Study of Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC

Fudan University1 site in 1 country70 target enrollmentSeptember 2007

ConditionsMetastatic Breast Cancer

Interventionsgemcitabine and cisplatin

Drugsgemcitabine and cisplatin

Overview

Phase: Phase 2
Intervention: gemcitabine and cisplatin
Conditions: Metastatic Breast Cancer
Sponsor: Fudan University
Enrollment: 70
Locations: 1
Primary Endpoint: PFS (progression free survival)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as first line therapy in patients with triple-negative MBC. 80 patients will be treated into this study.

Detailed Description

Triple-negative breast tumors could contribute to the poor prognosis comparing with luminal A breast cancer.Fewer study has revealed that Cisplatin-based therapy may be effective for this type breast cancer.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

September 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fudan University

Eligibility Criteria

Inclusion Criteria

•Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice
•Be female and ≥18 and ≤75 years of age
•Be ambulatory and have ECOG performance stastus of ≤1
•Have histological confirmed breast cancer,and the speciman confirmed ER negative,PR negatiev, and HER-2 negative by immunochemistry technich of Fudan cancer hospital.
•Locally advanced or metastastic breast cancer who didn't receive first-line chemotherapy. No matter whether the patient has received anthracyclin or taxane treatment as neo-adjuvant or adjuvant treatment.
•Have at least one target lesion according to the RECIST criteria.
•Exclusion criteria:
•Preganant or lactating women
•Advaced patient has received one or more chemotherapies
•Chemotherapy within four weeks preceding treatment start

Exclusion Criteria

Not provided

Arms & Interventions

gemcitabine and cisplatin

cisplatin and gemcitabine in the management of triple negative metastatic breast cancer

Intervention: gemcitabine and cisplatin

Outcomes

Primary Outcomes

PFS (progression free survival)

Time Frame: 1 year

Secondary Outcomes

BRCA1 mutation realtionship with efficacy and toxicity analysis(at the end of therapy)
side effects(6 months)
pharmacogenetic analysis(collect blood samples before therapy)