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

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00356681

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 II

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Bevacizumab Motesanib

U.S. FDA Resources

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
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A Blinded AMG 706 placebo	Drug: AMG 706 placebo AMG 706 placebo 125mg QD until disease progression, consent withdrawal or unacceptable toxicity
Active Comparator: B Blinded AMG 706	Drug: AMG 706 AMG 706 125mg PO QD until disease progression, consent withdrawal or unacceptable toxicity
Experimental: C 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

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

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Martin M, Roche H, Pinter T, Crown J, Kennedy MJ, Provencher L, Priou F, Eiermann W, Adrover E, Lang I, Ramos M, Latreille J, Jagie??o-Gruszfeld A, Pienkowski T, Alba E, Snyder R, Almel S, Rolski J, Munoz M, Moroose R, Hurvitz S, Baños A, Adewoye H, Hei YJ, Lindsay MA, Rupin M, Cabaribere D, Lemmerick Y, Mackey JR; TRIO 010 investigators. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2011 Apr;12(4):369-76. Epub 2011 Mar 21.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00356681 History of Changes
Other Study ID Numbers:	20050225, CIRG/TORI 010
Study First Received:	July 24, 2006
Last Updated:	September 1, 2011
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012