Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients
A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in Combination With Bevacizumab and Paclitaxel or AMG 386 Plus Paclitaxel as First-Line Therapy in Subjects With Her2-Negative, Metastatic or Locally Recurrent Breast Cancer
1 other identifier
interventional
228
12 countries
71
Brief Summary
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2007
Longer than P75 for phase_2
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 2, 2007
CompletedFirst Posted
Study publicly available on registry
August 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedOctober 29, 2015
October 1, 2015
3.1 years
August 2, 2007
October 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
3 YEARS
Secondary Outcomes (8)
Objective Response (OR)
3 YEARS
Duration of Response (DOR)
3 YEARS
Time to response
3 YEARS
Overall Survival
3 YEARS
Time to progression (TTP)
3 YEARS
- +3 more secondary outcomes
Study Arms (4)
A
EXPERIMENTALPaclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 10 mg/kg IV QW
D
EXPERIMENTALPaclitaxel 90 mg/m² IV QW (3 on/1 off) + Open Label AMG 386 10 mg/kg IV QW
B
EXPERIMENTALPaclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 3 mg/kg IV QW
C
ACTIVE COMPARATORPaclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 placebo IV QW
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
- Measurable or non-measurable disease per modified RECIST guidelines
- ECOG of 0 or 1 (within 14 days prior to randomization)
- Adequate organ and hematological function as evidenced by the following laboratory studies within 14 days prior to randomization:
- Cardiac function, as follows:
- Normal sinus rhythm (no significant ECG changes)
- Left ventricular ejection fraction ≥ LLN, as determined by echocardiogram or MUGA scan, according to institutional standards within 28 days prior to randomization
You may not qualify if:
- Inflammatory Breast Cancer
- Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 peripheral neuropathy \> grade 1 at randomization
- History of arterial or venous thrombosis, including transient ischemic attack (TIA), within 1 year prior to randomization
- Adjuvant or neoadjuvant taxane treatment within 12 months of randomization. Any other adjuvant chemotherapy regimen must be discontinued at least 21 days prior to randomization
- Prior chemotherapy, vaccine, or biological therapy 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 disease unless disease progression was subsequently documented 14 days prior to randomization.
- Overexpression of HER-2 (gene amplification by FISH or 3+ over expression by immunohistochemistry).
- Current or prior history of central nervous system metastasis
- History of bleeding diathesis or clinically significant bleeding within 6 months prior to randomization
- Major surgical procedure within 28 days prior to randomization
- Open breast biopsy within 14 days prior to randomization
- Minor surgical procedure, placement of access device, or fine needle aspiration within 7 days of first dose
- Prior malignancy (other than thyroid cancer, in situ cervical cancer, or basal cell cancer of the skin, treated with curative intent and without evidence of disease for ≥ 3 years prior to randomization)
- Clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication
- Non-healing wound, ulcer or fracture
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (77)
Research Site
Litchfield Park, Arizona, 85340, United States
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Tucson, Arizona, 85724, United States
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Hot Springs, Arkansas, 71913, United States
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Little Rock, Arkansas, 72205, United States
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Campbell, California, 95008, United States
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Los Angeles, California, 90095, United States
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Murrieta, California, 92562, United States
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Santa Maria, California, 93454, United States
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New Haven, Connecticut, 06520, United States
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Stamford, Connecticut, 06902, United States
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Orlando, Florida, 32804, United States
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Robbinsdale, Minnesota, 55422, United States
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Henderson, Nevada, 89052, United States
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Lebanon, New Hampshire, 03756, United States
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Nashua, New Hampshire, 03061, United States
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Edison, New Jersey, 08820, United States
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Mountain Lakes, New Jersey, 07046, United States
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Asheville, North Carolina, 28806, United States
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Charlotte, North Carolina, 28203, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19106, United States
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Columbia, South Carolina, 29210, United States
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Richardson, Texas, 75080, United States
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San Antonio, Texas, 78229, United States
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Sugar Land, Texas, 77479, United States
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Ogden, Utah, 84403, United States
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Kurralta Park, South Australia, 5037, Australia
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Epping, Victoria, 3076, Australia
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Fitzroy, Victoria, 3065, Australia
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Footscray, Victoria, 3011, Australia
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Malvern, Victoria, 3144, Australia
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Perth, Western Australia, 6000, Australia
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Innsbruck, 6020, Austria
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Vienna, 1090, Austria
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Wels, 4600, Austria
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Wilrijk, 2610, Belgium
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Herlev, 2730, Denmark
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Helsinki, 00029, Finland
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La Roche-sur-Yon, 85925, France
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Lyon, 69008, France
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Marseille, 13009, France
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Montpellier, 34298, France
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Paris, 75020, France
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Paris, 75248, France
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Toulouse, 31052, France
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Vandœuvre-lès-Nancy, 54511, France
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Gyula, 5700, Hungary
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Kaposvár, 7400, Hungary
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Szombathely, 9700, Hungary
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Veszprém, 8200, Hungary
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Bangalore, Karnataka, 560 029, India
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Miraj, Maharashtra, 416 410, India
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Mumbai, Maharashtra, 400 012, India
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Nagpur, Maharashtra, 440 012, India
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Pune, Maharashtra, 411 001, India
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Jaipur, Rajasthan, 302 004, India
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Jaipur, Rajasthan, 302 013, India
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Maastricht, 6229 HX, Netherlands
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Gdansk, 80-952, Poland
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Lubin, 59-300, Poland
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Poznan, 61-485, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-141, Poland
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Wroclaw, 53-413, Poland
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Jaén, AndalucÃ-a, 23007, Spain
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Sabadell, Cataluña, 08208, Spain
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Santiago de Compostela, Galicia, 15706, Spain
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Madrid, Madrid, 28033, Spain
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Guildford, GU2 7XX, United Kingdom
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Leicester, LE1 5WW, United Kingdom
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London, NW1 2PG, United Kingdom
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London, W6 8RF, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
Dieras V, Wildiers H, Jassem J, Dirix LY, Guastalla JP, Bono P, Hurvitz SA, Goncalves A, Romieu G, Limentani SA, Jerusalem G, Lakshmaiah KC, Roche H, Sanchez-Rovira P, Pienkowski T, Segui Palmer MA, Li A, Sun YN, Pickett CA, Slamon DJ. Trebananib (AMG 386) plus weekly paclitaxel with or without bevacizumab as first-line therapy for HER2-negative locally recurrent or metastatic breast cancer: A phase 2 randomized study. Breast. 2015 Jun;24(3):182-90. doi: 10.1016/j.breast.2014.11.003. Epub 2015 Mar 5.
PMID: 25747197DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2007
First Posted
August 3, 2007
Study Start
July 1, 2007
Primary Completion
August 1, 2010
Study Completion
May 1, 2014
Last Updated
October 29, 2015
Record last verified: 2015-10