BOOG Study Center
F. Erdkamp, M.M.E.M. Bos
A.E. van Leeuwen-Stok
IKNL locatie Amsterdam, Trialbureau PO Box 9236 1006 AE Amsterdam Email amsterdam.trialbureau@iknl.nl Tel 088-234 65 00 Fax 088 – 234 6011
SMS-Oncology
Randomization: Arm A: patients will receive 8 continuous cycles of chemotherapy in first and second line treatment. Arm B: patients will receive 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first and second line treatment. In first line treatment, patients in both study arms will receive paclitaxel and bevacizumab continued with bevacizumab only until Progressive Disease (PD) or unacceptable toxicity, whichever comes first. As second line treatment patients will receive non-pegylated liposomal doxorubicin.
Primary: To demonstrate that the progression-free survival (PFS) of 8 cycles of intermittent (2 times 4 cycles) chemotherapy (paclitaxel) is not inferior in efficacy, compared to 8 continuous cycles of chemotherapy (paclitaxel), both in combination with bevacizumab, in first line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer. Secondary: To compare the PFS of second line treatment of 8 continuous cycles of chemotherapy with liposomal doxorubicin (or capecitabine) with 8 cycles of intermittent (2 times 4 cycles) chemotherapy with liposomal doxorubicin (or capecitabine); To compare the objective Overall Response Rate (ORR) between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first treatment line, combined with bevacizumab, and in second treatment line; To compare the Duration of Objective Response (DOR) between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first treatment line, combined with bevacizumab, and second treatment line; For the intermittent chemotherapy schedule the first DOR and, if applicable, second DOR in the same treatment line will be accumulated; To compare Overall Survival (OS) between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy; To compare the Safety between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy; To compare the Quality of Life (QoL) between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy To compare the Pharmacoeconomics between 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy.
Primary endpoint:
Secondary endpoints:
Other:
Female patients ≥ 18 years old. Patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer, who are candidates for chemotherapy. Patients with measurable or evaluable-only disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria as determined by the investigator. Documented Estrogen Receptor (ER) / Progesteron Receptor (PR) status. HER2/neu-negative disease as determined by immunohistochemistry or Fluorescence In Situ Hybridization (FISH). Patients with an ECOG Performance Status ≤ 2. Life expectancy of >=12 weeks. Signature of Informed Consent Form by patient
