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

Sponsor

Harbin Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01483300

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: lobaplatin Drug: cisplatin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2011

Anticipated Primary Completion Date :

Aug 1, 2014

Anticipated Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lobaplatin gemcitabine plus lobaplatin	Drug: lobaplatin Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
Active Comparator: cisplatin gemcitabine plus cisplatin	Drug: cisplatin Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks

Arm

Intervention/Treatment

Experimental: lobaplatin

gemcitabine plus lobaplatin

Drug: lobaplatin

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

Active Comparator: cisplatin

gemcitabine plus cisplatin

Drug: cisplatin

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

Outcome Measures

Primary Outcome Measures

Overall response rate [4 weeks after chemotherapy]
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)

Secondary Outcome Measures

Time to progression [one year after last patient in]
Time to progression defined as time from randomization to disease progress.
Overall Survival [one year after last patient in]
Overall survival defined as time from randomization to death from any cause.
Treatment related toxicity [4 weeks after chemotherapy]
Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150081

Sponsors and Collaborators

Harbin Medical University

Investigators

Study Director: Qingyuan Zhang, MD, Cancer Hospital of Harbin Medical University
Principal Investigator: Xinmei Kang, MD, Cancer Hospital of Harbin Medical University