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)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00356681
First received: July 24, 2006
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356681

Sponsors and Collaborators
Amgen
Investigators
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
Paclitaxel
Metastatic Breast Cancer
Antiangiogenic
Bevacizumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014