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Trial Title: Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer

NCT ID: NCT01483300

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Cisplatin

Conditions: Keywords:
breast cancer
gemcitabine
lobaplatin
cisplatin

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: lobaplatin
Description: Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
Arm group label: lobaplatin

Intervention type: Drug
Intervention name: cisplatin
Description: Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks
Arm group label: cisplatin

Summary: Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically confirmed metastatic breast cancer - Disease progression during or after previous 1st line chemotherapy - Scheduled to receive 2nd line chemotherapy. - Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension - 18 years of age or older - ECOG performance status of 0-2 - Life expectancy of greater than 6 months Exclusion Criteria: - Previous treatment with one of the study drugs - Application of other cytotoxic chemotherapy or radiotherapy - Insufficent renal function (creatinine clearance < 60ml/min) - Clinically unstable brain metastasis - Pregancy or lactation - History of other malignancy within last 5 years.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Hospital of Harbin Medical University

Address:
City: Harbin
Zip: 150081
Country: China

Status: Recruiting

Contact:
Last name: Qingyuan Zhang, MD

Phone: 86-451-86298276
Email: zhma19650210@163.com

Contact backup:
Last name: Xinmei Kang, MD

Phone: 86-451-86298683
Email: kxm791107@163.com

Investigator:
Last name: Qingyuan Zhang, MD
Email: Principal Investigator

Investigator:
Last name: Xinmei Kang, MD
Email: Sub-Investigator

Start date: November 2011

Completion date: November 2014

Lead sponsor:
Agency: Harbin Medical University
Agency class: Other

Source: Harbin Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01483300

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