Metastatic Breast Cancer
Conditions
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
Interventions
DRUGVinorelbine
DRUGGemcitabine
DRUGCisplatin
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 | Safety of treatment will be evaluated by the frequency of adverse events and serious adverse events, clinically significant abnormal laboratory tests, vital signs, and Eastern Cooperative Oncology Group(ECOG)performance status(PS). All patients who received at least one dose of study treatment will be included in the safety analysis. |
Contacts
Primary ContactZhiyong Yu, PhD
Backup ContactXinzhao Wang, MD
Outcome results
None listed