Clinical trial · Interventional
Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
Phase Ⅱ Study of Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
NCT00601159CI-TRIAL-00005154completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine and cisplatin
- description
- cisplatin and gemcitabine in the management of triple negative metastatic breast cancer
- interventionNames
- Drug: gemcitabine and cisplatin
Primary outcomes (1)
- measure
- PFS (progression free survival)
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- side effects
- timeFrame
- 6 months
- measure
- BRCA1 mutation realtionship with efficacy and toxicity analysis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDTurner 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
- DERIVEDZhang 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