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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01483300
• Other study ID #: BC001
• Status: Recruiting
• Phase: Phase 2
• First received: November 25, 2011
• Last updated: January 22, 2012
• Start date: November 2011
• Est. completion date: November 2014

Study information

• Verified date: January 2012
• Source: Harbin Medical University
• Contact: Qingyuan Zhang, MD
• Phone: 86-451-86298276
• Email: zhma19650210[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• lobaplatin
Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
• cisplatin
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks

Locations

Country	Name	City	State
China	Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)	4 weeks after chemotherapy	No
Secondary	Time to progression	Time to progression defined as time from randomization to disease progress.	one year after last patient in	No
Secondary	Overall Survival	Overall survival defined as time from randomization to death from any cause.	one year after last patient in	No
Secondary	Treatment related toxicity	Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.	4 weeks after chemotherapy	Yes