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A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

Information source: Amgen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Breast Tumors; Metastatic Cancer

Intervention: AMG 479 or placebo administered with either exemestane or fulvestrant (Drug); AMG 479 or placebo administered with either exemestane or fulvestrant (Drug); AMG 479 or placebo administered with either exemestane or fulvestrant (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.

Clinical Details

Official title: An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Progression free survival (PFS), as measured by Response Evaluation Criteria in Solid Tumors criteria (modified RECIST) per local review

Secondary outcome:

Incidence of adverse events, abnormal laboratory values, and anti-AMG 479 antibody formation

PK parameters of AMG 479

Breast cancer related symptoms, health related quality of life, and skin toxicity burden

Clin benefit(complete/partial response,or stable disease≥24 wks per modified RECIST/local review),objective response rate(complete/partial response per modified RECIST/local review),duration of response,TTP,time-to-response,time-to-tx failure,survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Histologically or cytologically confirmed carcinoma of the breast with locally

advanced or metastatic disease

- Confirmation of hormone receptor (HR) positive disease status

- Amenable to receive endocrine therapy

- Disease progression while receiving prior endocrine therapy for locally advanced or

metastatic breast cancer

- Postmenopausal woman ≥ 18 years old

Exclusion Criteria:

- HR-unknown or HR-negative disease

- Not amenable to endocrine therapy

- Central nervous system metastasis

Locations and Contacts

Research Site, Dijon 21079, France

Research Site, Le Mans 72000, France

Research Site, Lyon 69008, France

Research Site, Montpellier Cedex 5 34298, France

Research Site, Nice Cedex 2 06182, France

Research Site, Paris Cedex 5 75248, France

Research Site, Reims Cedex 51056, France

Research Site, Saint Herblain 44800, France

Research Site, Frankfurt 60590, Germany

Research Site, Frankfurt 65929, Germany

Research Site, Hannover 30177, Germany

Research Site, München 80637, Germany

Research Site, Dublin 4, Ireland

Research Site, Dublin 8, Ireland

Research Site, Madrid 28040, Spain

Research Site, Chur 7000, Switzerland

Research Site, Luzern 16 6000, Switzerland

Research Site, Zurich 8032, Switzerland

Research Site, Derby DE22 3DT, United Kingdom

Research Site, London W6 8RF, United Kingdom

Research Site, Manchester M20 4BX, United Kingdom

Research Site, Peterborough PE3 9GZ, United Kingdom

Research Site, Chandler, Arizona 85224, United States

Research Site, Vancouver, British Columbia V5Z 4E6, Canada

Research Site, Anaheim, California 92801, United States

Research Site, Beverly Hills, California 90211, United States

Research Site, Concord, California 94520, United States

Research Site, Duarte, California 91010, United States

Research Site, Montebello, California 90640, United States

Research Site, San Francisco, California 94115, United States

Research Site, Sylmar, California 91342, United States

Research Site, Barcelona, Cataluña 08003, Spain

Research Site, L'Hospitalet de Llobregat, Cataluña 08907, Spain

Research Site, Sabadell, Cataluña 08208, Spain

Research Site, Stamford, Connecticut 06902, United States

Research Site, Boca Raton, Florida 33428, United States

Research Site, Boynton Beach, Florida 33435, United States

Research Site, Coral Springs, Florida 33065, United States

Research Site, Gainesville, Florida 32605, United States

Research Site, Lake Worth, Florida 33467, United States

Research Site, Atlanta, Georgia 30309, United States

Research Site, Marietta, Georgia 30060, United States

Research Site, Chicago, Illinois 60637, United States

Research Site, Lebanon, New Hampshire 03756, United States

Research Site, Denville, New Jersey 07834, United States

Research Site, Waratah, New South Wales 2298, Australia

Research Site, High Point, North Carolina 27262, United States

Research Site, Ottawa, Ontario K1H 8L6, Canada

Research Site, Sault Ste. Marie, Ontario P6B 0A8, Canada

Research Site, Toronto, Ontario M5G 2M9, Canada

Research Site, Hershey, Pennsylvania 17033, United States

Research Site, Pittsburgh, Pennsylvania 15213, United States

Research Site, Montreal, Quebec H1T 2M4, Canada

Research Site, Woodville South, South Australia 5011, Australia

Research Site, Memphis, Tennessee 38120, United States

Research Site, American Fork, Utah 84003, United States

Research Site, Footscray, Victoria 3011, Australia

Research Site, Geelong, Victoria 3220, Australia

Research Site, Malvern, Victoria 3144, Australia

Research Site, Tacoma, Washington 98405, United States

Additional Information

AmgenTrials clinical trials website

Related publications:

Robertson JF, Ferrero JM, Bourgeois H, Kennecke H, de Boer RH, Jacot W, McGreivy J, Suzuki S, Zhu M, McCaffery I, Loh E, Gansert JL, Kaufman PA. Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. Lancet Oncol. 2013 Mar;14(3):228-35. doi: 10.1016/S1470-2045(13)70026-3. Epub 2013 Feb 13.

Starting date: March 2008
Last updated: January 16, 2015

Page last updated: August 20, 2015

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