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

NCT01483300 | Unknown Phase 2 DMC

• 1 other identifier: BC001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer; gemcitabine; lobaplatin; cisplatin

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)

  4 weeks after chemotherapy

Secondary Outcomes (3)

• Time to progression

  one year after last patient in

• Overall Survival

  one year after last patient in

• Treatment related toxicity

  4 weeks after chemotherapy

Study Arms (2)

lobaplatin

EXPERIMENTAL

gemcitabine plus lobaplatin

Drug: lobaplatin

cisplatin

ACTIVE COMPARATOR

gemcitabine plus cisplatin

Drug: cisplatin

Interventions

lobaplatin DRUG

Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks

lobaplatin

cisplatin DRUG

Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks

cisplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• ECOG performance status of 0-2
• Life expectancy of greater than 6 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

lobaplatin; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Qingyuan Zhang, MD

  Cancer Hospital of Harbin Medical University

  STUDY DIRECTOR

• Xinmei Kang, MD

  Cancer Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingyuan Zhang, MD

CONTACT

86-451-86298276; zhma19650210@163.com

Xinmei Kang, MD

CONTACT

86-451-86298683; kxm791107@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Cancer Hospital of Harbin Medical University

Study Record Dates

• First Submitted: November 25, 2011
• First Posted: December 1, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

CN (1)