Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

NCT ID: NCT02544243

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30

Brief Summary

Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.

Study Design:

Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

B

Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Interventions

Vinorelbine

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed metastatic breast cancer
• All patients were required to give written informed consent
• To have received a previous treatment with anthracyclines and taxanes
• Previous radiotherapy is allowed, whenever the radiated area is not the only disease location
• At least 4 weeks since the last previous antineoplastic treatment
• Patients must have recovered from all previous toxicities
• Karnofsky Performance status >= 70%
• Adequate hematological, renal, cardiac and hepatic function
• Life expectancy of at least 12 weeks
• Patients able to comply and to receive an adequate follow-up

Exclusion Criteria

• Only bone metastases
• Active infection
• Previous treatment with one of the study drugs
• Application of other cytotoxic chemotherapy
• Insufficient renal function (creatinine clearance < 60ml/min)
• Clinically unstable brain metastasis
• Pregnancy or lactation
• Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin)
• Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted
• Males
• Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma

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

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Zhiyong Yu

Director of the Breast Surgery Ⅰ

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiyong Yu, PhD

Role: STUDY_CHAIR

Shandong Cancer Hospital and Institute

Xinzhao Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Central Contacts

Zhiyong Yu, PhD

Role: CONTACT

drzhiyongyu@aliyun.com

86-13355312277

Xinzhao Wang, MD

Role: CONTACT

08wangxinzhao@163.com

86-15154156639

Other Identifiers

ShandongCHI-05

Identifier Type: -

Identifier Source: org_study_id