Clinical trial NCT00601159: Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
Official title: Phase Ⅱ Study of Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer
triple-negative Breast Cancer
cisplatin
chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: PFS (progression free survival)
timeFrame: 1 year
Secondary outcomes:
measure: side effects
timeFrame: 6 months
measure: BRCA1 mutation realtionship with efficacy and toxicity analysis
timeFrame: at the end of therapy
measure: pharmacogenetic analysis
timeFrame: collect blood samples before therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhonghua Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1038/sj.onc.1210014. Epub 2006 Oct 2.
citation: Zhang J, Wang Z, Hu X, Wang B, Wang L, Yang W, Liu Y, Liu G, Di G, Hu Z, Wu J, Shao Z. Cisplatin and gemcitabine as the first line therapy in metastatic triple negative breast cancer. Int J Cancer. 2015 Jan 1;136(1):204-11. doi: 10.1002/ijc.28966. Epub 2014 May 23.