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
18 Years
N/A
Female
Breast Neoplasms, Breast Tumors, Breast Cancer, Locally Recurrent and Metastatic Breast Cancer
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Objective response rate, measured radiologically and assessed by an independent review committee.
Outcome Time Frame:
Last patient enrolled + 16 weeks of treatment
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Australia: Therapeutic Goods Administration
Study ID:
20050225
NCT ID:
NCT00356681
Start Date:
December 2006
Completion Date:
August 2012
Related Keywords:
- Breast Neoplasms
- Breast Tumors
- Breast Cancer
- Locally Recurrent and Metastatic Breast Cancer
- AMG 706
- Paclitaxel
- Metastatic Breast Cancer
- Antiangiogenic
- Bevacizumab
- Breast Neoplasms
- Neoplasms
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