A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer

NCT ID: NCT01550848

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-06-30

Brief Summary

The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Detailed Description

This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abraxane and Gemcitabine

Abraxane and Gemcitabine

Group Type: EXPERIMENTAL

Abraxane and Gemcitabine

Intervention Type: DRUG

ABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15

GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15

Interventions

Abraxane and Gemcitabine

ABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15

GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15

Intervention Type: DRUG

Other Intervention Names

Combined Chemotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xichun Hu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xichun Hu, MD;PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, , China

Countries

China

References

Li 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.

Reference Type: DERIVED

PMID: 30837503 (View on PubMed)

Zhao 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.

Reference Type: DERIVED

PMID: 30348118 (View on PubMed)

Other Identifiers

Fudan BR2011-07

Identifier Type: -

Identifier Source: org_study_id