Clinical trial · Interventional
A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer
A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer
NCT01550848CI-TRIAL-00019076completedPhase 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)
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
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 |
|---|---|---|---|
| Abraxane and Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abraxane and Gemcitabine
- description
- Abraxane and Gemcitabine
- interventionNames
- Drug: Abraxane and Gemcitabine
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 8 weeks
Secondary outcomes (1)
- measure
- number of adverse events
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female between 18 and 70 years old; * Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery; * ECOG (Eastern Cooperative Oncology Group) 0\~1; * Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L; * Got ICF (Informed Consent Form) before enrollment; * Life expectancy more than 12 weeks Exclusion Criteria: * Pregnant or breast-feeding women or positive serum pregnancy test; * Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling; * Participation in any investigational drug study within 4 weeks preceding treatment start; * Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer; * Serious uncontrolled intercurrent infections; * Poor compliance
References
Publications (2)
- DERIVEDLi Y, Zhao Y, Gong C, Xie Y, Hu X, Zhang J, Wang L, Zhang S, Cao J, Tao Z, Wang B. Cisplatin shows greater efficacy than gemcitabine when combined with nab-paclitaxel in metastatic triple-negative breast cancer. Sci Rep. 2019 Mar 5;9(1):3563. doi: 10.1038/s41598-019-39314-y. PMID 30837503
- DERIVEDZhao Y, Lv F, Chen S, Wang Z, Zhang J, Zhang S, Cao J, Wang L, Cao E, Wang B, Hu X. Caveolin-1 expression predicts efficacy of weekly nab-paclitaxel plus gemcitabine for metastatic breast cancer in the phase II clinical trial. BMC Cancer. 2018 Oct 22;18(1):1019. doi: 10.1186/s12885-018-4936-y. PMID 30348118