| July 24, 2006 |
| November 5, 2009 |
| December 2006 |
| July 2009 (final data collection date for primary outcome measure) |
| Objective response rate, measured radiologically and assessed by an independent review committee. [ Time Frame: Last patient enrolled + 16 weeks of treatment ] [ Designated as safety issue: No ] |
| Objective response rate, measured radiologically and assessed by an independent review committee. |
| Complete list of historical versions of study NCT00356681 on ClinicalTrials.gov Archive Site |
| 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. [ Time Frame: >24 weeks ] [ Designated as safety issue: No ] |
| 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. |
| |
| A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer |
| A Randomized Phase 2 Trial of Double-Blind, Placebo Controlled AMG 706 in Combination With Paclitaxel, or Open-Label Bevacizumab in Combination With Paclitaxel, as First Line Therapy in Women With HER2 Negative Locally Recurrent or Metastatic Breast Cancer |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
- Breast Neoplasms
- Breast Tumors
- Breast Cancer
- Locally Recurrent and Metastatic Breast Cancer
|
- Drug: AMG 706 placebo
- Drug: Bevacizumab
- Drug: AMG 706
|
- Placebo Comparator: Blinded AMG 706 placebo
- Active Comparator: Blinded AMG 706
- Experimental: Open-label bevacizumab
|
| |
| |
| Active, not recruiting |
| 282 |
| December 2013 |
| July 2009 (final data collection date for primary outcome measure) |
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.
|
| Female |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Canada, France, Germany, Hong Kong, Hungary, India, Ireland, New Zealand, Poland, Spain |
| |
| NCT00356681 |
| Global Development Leader, Amgen Inc. |
| 20050225, CIRG/TORI 010 |
| Amgen |
|
|
|
| Amgen |
| November 2009 |
