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

NCT00601159 | Completed Phase 2

• 1 other identifier: 200709GP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; triple-negative Breast Cancer; cisplatin; chemotherapy

Outcome Measures

Primary Outcomes (1)

• PFS (progression free survival)

  1 year

Secondary Outcomes (3)

• side effects

  6 months

• BRCA1 mutation realtionship with efficacy and toxicity analysis

  at the end of therapy

• pharmacogenetic analysis

  collect blood samples before therapy

Study Arms (1)

gemcitabine and cisplatin

EXPERIMENTAL

cisplatin and gemcitabine in the management of triple negative metastatic breast cancer

Drug: gemcitabine and cisplatin

Interventions

gemcitabine and cisplatin DRUG

Cispaltin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 repeat every 3 weeks

Also known as: gemzar

gemcitabine and cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, +86200032, China

Location

Related Publications (2)

• 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.

  PMID: 17016441 BACKGROUND

• 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.

  PMID: 24824628 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Zhonghua Wang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 25, 2008
• Study Start: September 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 4, 2011

Record last verified: 2011-06

Locations

CN (1)