A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00885755

First received: March 16, 2009

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Purpose

This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: trastuzumab [Herceptin] Drug: Standard taxane therapy Drug: capecitabine [Xeloda]	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Study to Evaluate Alterations in Molecular Biomarkers in HER2 Neu Positive Metastatic Breast Cancer Together With Assessment of Trastuzumab Use Beyond Progression After Initial Response to Trastuzumab-taxane Based Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine Trastuzumab

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Time to progression [ Time Frame: Event driven--monitored at each clinic visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response to Herceptin/Xeloda (in patients who progress) [ Time Frame: Event driven--monitored at each clinic visit ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Event driven--monitored at each clinic visit ] [ Designated as safety issue: No ]
Adverse events, serious adverse events [ Time Frame: Throughout study--monitored at each clinic visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	August 2009
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: trastuzumab [Herceptin] 8mg/kg iv loading dose on day 1 of first 3-week cycle, and 6mg/kg iv on day 1 of each subsequent cycle Drug: Standard taxane therapy As prescribed Drug: capecitabine [Xeloda] 1000mg/m2 po bid on days 1-14 of each 3-week cycle (only in patients who have progressed)

Eligibility

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

Criteria

Inclusion Criteria:

female patients, >=18 years of age;
HER2-positive breast cancer;
al least one metastatic site amenable for core biopsy;
left ventricular ejection fraction >50%.

Exclusion Criteria:

prior adjuvant/neoadjuvant Herceptin within past 6 months;
prior adjuvant taxane therapy within past 12 months;
use of chemotherapy, immunotherapy or biological anticancer therapy within past 3 weeks;
known bleeding diatheses.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885755

Contacts

Contact: Please reference Study ID Number: MO22004 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

Australia
	Terminated
Camperdown, Australia, 2050
	Completed
East Ringwood, Australia, 3135
	Completed
Perth, Australia, 6000
	Terminated
St. Leonards, Australia, 2065
	Terminated
Wodonga, Australia, 3690
Spain
	Terminated
Santander, Spain, 39008
	Active, not recruiting
Valencia, Spain, 46010
Sweden
	Recruiting
Stockholm, Sweden, 17176
	Completed
Uppsala, Sweden, 75185
United Kingdom
	Completed
Hull, United Kingdom, HU3 2JZ
	Completed
Manchester, United Kingdom, M20 4BX
	Completed
Nottingham, United Kingdom, NG5 1PB

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00885755 History of Changes
Other Study ID Numbers:	MO22004, 2008-004013-94
Study First Received:	March 16, 2009
Last Updated:	May 7, 2013
Health Authority:	Australia: National Health and Medical Research Council

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Taxane
Trastuzumab

Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013

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