Vinorelbine/Carboplatin Versus Gemcitabine/Carboplatin in Metastatic Breast Cancer

Shandong Cancer Hospital and Institute200 enrolled

Overview

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;

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Metastatic Breast Cancer

Interventions

VinorelbineDRUG

injection

GemcitabineDRUG

injection

CarboplatinDRUG

injection

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically confirmed metastatic breast cancer; 2. All patients were required to give written informed consent; 3. To have received a previous treatment with anthracyclines and taxanes; 4. Previous radiotherapy is allowed, whenever the radiated area is not the only disease location; 5. At least 4 weeks since the last previous antineoplastic treatment; 6. Patients must have recovered from all previous toxicities; 7. Karnofsky Performance status \>= 70%; 8. Adequate hematological, renal, cardiac and hepatic function; 9. Life expectancy of at least 12 weeks; 10. Patients able to comply and to receive an adequate follow-up; Exclusion Criteria: 1. Only bone metastases; 2. Active infection; 3. Previous treatment with one of the study drugs; 4. Application of other cytotoxic chemotherapy; 5. Insufficient renal function (creatinine clearance \< 60ml/min); 6. Clinically unstable brain metastasis; 7. Pregnancy or lactation; 8. Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin); 9. 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; 10. Males; 11. 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;