A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00796107

Purpose

This study will determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer will receive letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks. A second cohort of patients who have either progressed or plateaued on letrozole treatment will receive 3-weekly cycles of combination treatment with letrozole and R1507. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: R1507 Drug: letrozole	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Adverse events (Part 1) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Objective tumor response (Part 2) [ Time Frame: Weeks 6, 12, 18, 24 and then every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events and laboratory parameters, PK profile (Part 2) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Progression-free survival, time to progression, time to response (Part 2) [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Estimated Enrollment:	43
Study Start Date:	December 2008
Estimated Study Completion Date:	May 2010

Arms	Assigned Interventions
1: Experimental	Drug: R1507 16mg/kg iv every 3 weeks Drug: letrozole 2.5mg po daily

Eligibility

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

Criteria

Inclusion Criteria:

postmenopausal female patients;
stage IV or locally advanced breast cancer;
measurable disease;
letrozole failure (Part 2);
ECOG performance status <=2.

Exclusion Criteria:

previous chemotherapy for metastatic breast cancer;
concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug;
history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix;
concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796107

Contacts

Contact: Please reference Study ID Number: NO21161	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

United States, Florida

Miami, Florida, United States, 33136
United States, Georgia

ATLANTA, Georgia, United States, 30322
United States, Missouri

ST. LOUIS, Missouri, United States, 63110
United States, Texas

Houston, Texas, United States, 77030

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NO21161
Study First Received:	November 21, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00796107
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009