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

This study has been completed.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00601159
First received: December 26, 2007
Last updated: July 1, 2011
Last verified: June 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • PFS (progression free survival) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601159

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

Publications:

Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital
ClinicalTrials.gov Identifier: NCT00601159     History of Changes
Other Study ID Numbers: 200709GP
Study First Received: December 26, 2007
Last Updated: July 1, 2011
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013