Breast Cancer, Breast Neoplasms, Breast Tumors, Locally Recurrent and Metastatic Breast Cancer
Conditions
Keywords
AMG 706, Paclitaxel, Metastatic Breast Cancer, Antiangiogenic, Bevacizumab
Brief summary
To determine if treatment with paclitaxel plus AMG 706 is superior to paclitaxel plus AMG 706 placebo in subjects with HER2 negative locally recurrent or metastatic breast cancer. Also to estimate differences between treatment with paclitaxel plus AMG 706 and paclitaxel plus bevacizumab.
Interventions
DRUGAMG 706 placebo
Blinded placebo
DRUGBevacizumab
Bevacizumab is a recombinant, humanized anti-VEGF monoclonal antibody.
DRUGAMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology and PK studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively targeting all known VEGF, PDGF and Kit receptors.
DRUGPaclitaxel
Paclitaxel is an antineoplastic agent that acts by promoting and stabilizing the polymerization of microtubules.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. * Measurable disease by RECIST guidelines. * Tumor (primary or metastatic) must be HER2 negative. * Adequate organ and hematologic function. Exclusion: * Taxane treatment within 12 months prior to registration. * Prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted). * Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease. * Current or prior history of central nervous system metastases. * Peripheral neuropathy ≥ grade 2 (CTCAE v3.0) at registration. * History of arterial or venous thrombosis within 1 year prior to registration. * History of bleeding diathesis or bleeding within 14 days of registration. * Uncontrolled hypertension (systolic \>145 mmHg; diastolic \>85 mmHg). * Clinically significant cardiac disease within 12 months of registration. * Known HIV positive, hepatitis C positive or hepatitis B surface antigen positive. * Prior treatment with VEGFr targeted therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, measured radiologically and assessed by an independent review committee. | Last patient enrolled + 16 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, duration of response, clinical benefit rate (percentage of subjects with complete response, partial response or stable disease lasting >24 weeks), overall survival and incidence of adverse events. | >24 weeks |
Outcome results
None listed