Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601159
• Other study ID #: 200709GP
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: July 1, 2011
• Start date: September 2007
• Est. completion date: September 2010

Study information

• Verified date: June 2011
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

• ECOG = 2

• Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy

• Participation in any investigational drug study within 4 weeks preceeding treatment start

• Evidence of CNS metastasis

• History of another malignacy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer

• Abnormal laboratory values: hemoglobin < 8. 0g/dl, neutrophil< 1.5×109/L, platelet< 100×109/L.

• serum creatine > upper limit of normal (ULN)

• serum bilirubin > ULN

• ALT and AST >5×ULN

• AKP >5×ULN

• Serious uncontrolled intercurrence infection

• Life expectancy of less than 3 months

Study Design

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

Related Conditions & MeSH terms

• Metastatic Breast Cancer

Intervention

Drug:
• gemcitabine and cisplatin
Cispaltin 25mg/m2,ivgtt,D1, 2, 3 gemcitabine 1000mg/m2,ivgtt,30',D1, 8 repeat every 3 weeks

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

Turner NC, Reis-Filho JS, Russell AM, Springall RJ, Ryder K, Steele D, Savage K, Gillett CE, Schmitt FC, Ashworth A, Tutt AN. BRCA1 dysfunction in sporadic basal-like breast cancer. Oncogene. 2007 Mar 29;26(14):2126-32. Epub 2006 Oct 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS (progression free survival)		1 year	Yes
Secondary	side effects		6 months	Yes
Secondary	BRCA1 mutation realtionship with efficacy and toxicity analysis		at the end of therapy	Yes
Secondary	pharmacogenetic analysis		collect blood samples before therapy	Yes