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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00601159
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : July 4, 2011
Information provided by:
Fudan University

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: gemcitabine and cisplatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00601159

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

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
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: June 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