A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer

This study has been terminated.
(Sponsor decision to close study)
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: July 24, 2006
Last updated: September 12, 2012
Last verified: September 2012

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.

Condition Intervention Phase
Breast Neoplasms
Breast Tumors
Breast Cancer
Locally Recurrent and Metastatic Breast Cancer
Drug: AMG 706 placebo
Drug: Bevacizumab
Drug: AMG 706
Phase 2

Study Type: 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
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 282
Study Start Date: December 2006
Study Completion Date: August 2012
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm A Placebo
Blinded AMG 706 placebo
Drug: AMG 706 placebo
AMG 706 placebo 125mg QD until disease progression, consent withdrawal or unacceptable toxicity
Experimental: Arm B Experimental
Blinded AMG 706
Drug: AMG 706
AMG 706 125mg PO QD until disease progression, consent withdrawal or unacceptable toxicity
Active Comparator: Arm C Comparator
Open-label bevacizumab
Drug: Bevacizumab
Bevacizumab 10 mg/kg IV every 14 days until disease progression, consent withdrawal or unacceptable toxicity
Other Name: Avastin


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00356681

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00356681     History of Changes
Other Study ID Numbers: 20050225, CIRG/TORI 010
Study First Received: July 24, 2006
Last Updated: September 12, 2012
Health Authority: Australia: Therapeutic Goods Administration
France: Agence française de sécurité sanitaire des produits de santé
Germany: Bundesinstitute für Arzneimittel und Medizinprodukte
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Ireland: Irish Medicines Board
New Zealand: Ministry of Health, Medicines and Medical Devices Safety Authority
Poland: Office for Medicinal Products
Spain: Agencia española del medicamento
United States: Food and Drug Administration

Keywords provided by Amgen:
AMG 706
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 26, 2015