Breast Cancer Clinical Trial

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A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

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Summary

This study aim was to 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 received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.

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Eligibility Criteria

Inclusion Criteria:

postmenopausal female patients;
stage IV or locally advanced breast cancer;
measurable disease;
letrozole failure (Part 2);
Eastern Cooperative Oncology Group (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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT00796107

Recruitment Status:

Terminated

Sponsor:

Hoffmann-La Roche

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There are 6 Locations for this study

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Birmingham Alabama, 35294, United States

Washington District of Columbia, 20007, United States

Miami Florida, 33136, United States

Atlanta Georgia, 30322, United States

Saint Louis Missouri, 63110, United States

Houston Texas, 77030, United States
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How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT00796107

Recruitment Status:

Terminated

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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