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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
  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:


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

ClinicalTrials.gov processed this record on November 20, 2014