Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Carboplatin Versus Gemcitabine Plus Carboplatin
Overview
- Phase
- Phase 2
- Intervention
- Vinorelbine
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Shandong Cancer Hospital and Institute
- Enrollment
- 200
- Primary Endpoint
- Progression Free Survival
- Status
- Not yet recruiting
- Last Updated
- 6 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; Carboplatin AUC=6 d1 q 3 weeks; Arm B: Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1 q 3 weeks;
Investigators
Zhiyong Yu
Director of the Breast Surgery
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
Vinorelbine/Carboplatin
Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Intervention: Vinorelbine
Vinorelbine/Carboplatin
Vinorelbine 25 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Intervention: Carboplatin
Gemcitabine/Carboplatin
Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Intervention: Gemcitabine
Gemcitabine/Carboplatin
Gemcitabine 1000 mg/m2 d1,8; Carboplatin AUC=6 d1; q 3 weeks
Intervention: Carboplatin
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
- 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)
- 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)
- 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)
- 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)