A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
NCT ID: NCT00796107
Last Updated: 2020-11-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2009-01-28
2010-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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R1507 in Combination With Letrozole
Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
RG1507
R1507 was administered at a dose 16 mg/kg every 3 weeks.
Letrozole
Letrozole was administered orally at a dose 2.5 mg daily.
Interventions
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RG1507
R1507 was administered at a dose 16 mg/kg every 3 weeks.
Letrozole
Letrozole was administered orally at a dose 2.5 mg daily.
Eligibility Criteria
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Inclusion Criteria
* stage IV or locally advanced breast cancer;
* measurable disease;
* letrozole failure (Part 2);
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
St Louis, Missouri, United States
Houston, Texas, United States
Countries
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Other Identifiers
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NO21161
Identifier Type: -
Identifier Source: org_study_id