Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Fudan University Identifier:
First received: December 26, 2007
Last updated: July 1, 2011
Last verified: June 2011
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.

Condition Intervention Phase
Metastatic Breast Cancer
Drug: gemcitabine and cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • PFS (progression free survival) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • side effects [ Time Frame: 6 months ]
  • BRCA1 mutation realtionship with efficacy and toxicity analysis [ Time Frame: at the end of therapy ]
  • pharmacogenetic analysis [ Time Frame: collect blood samples before therapy ]

Enrollment: 70
Study Start Date: September 2007
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gemcitabine and cisplatin
cisplatin and gemcitabine in the management of triple negative metastatic breast cancer
Drug: gemcitabine and cisplatin
Cispaltin 25mg/m2,ivgtt,D1, 2, 3 gemcitabine 1000mg/m2,ivgtt,30',D1, 8 repeat every 3 weeks
Other Name: gemzar

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00601159

China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, +86200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Zhonghua Wang, MD Fudan University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital Identifier: NCT00601159     History of Changes
Other Study ID Numbers: 200709GP
Study First Received: December 26, 2007
Last Updated: July 1, 2011

Keywords provided by Fudan University:
Metastatic Breast Cancer
triple-negative Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 26, 2017