Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Gemcitabine Versus Vinorelbine Plus Cisplatin
Overview
- Phase
- Phase 2
- Intervention
- Vinorelbine
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Shandong Cancer Hospital and Institute
- Enrollment
- 200
- Primary Endpoint
- Progression Free Survival
- Last Updated
- 10 years ago
Overview
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
Investigators
Zhiyong Yu
Director of the Breast Surgery Ⅰ
Shandong Cancer Hospital and Institute
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
- •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
Arms & Interventions
A
Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks
Intervention: Vinorelbine
A
Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks
Intervention: Gemcitabine
B
Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks
Intervention: Vinorelbine
B
Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks
Intervention: Cisplatin
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
Secondary Outcomes
- Overall Survival(Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months)
- Duration of response(Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months)
- Incidence of Treatment-Emergent Adverse Events(Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months)
- Clinical Benefit Rate(Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months)