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

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00796107

Run by

Hoffmann-La Roche

People needed

6

Starts

2009-01-28

Expected to finish

2010-03-03

Last updated by the study team

2020-11-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — St Louis, Missouri, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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