Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer

Shandong First Medical University

Status and phase: Unknown; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Gemcitabine; Drug: Cisplatin; Drug: Vinorelbine

Study type: Interventional

Funder types: Other

Identifiers

NCT02544243

ShandongCHI-05

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: Vinorelbine

B

Experimental group

Description:

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

Treatment:

Drug: Cisplatin

Drug: Vinorelbine