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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: RG1507; Drug: Letrozole

• Registration Number: NCT00796107
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Study Start: 2009-01-28
• Primary Completion: 2010-03-03
• Study Completion: 2010-03-03
• Disposition First Submitted: 2016-07-07
• Disposition First Submitted QC: 2016-07-07
• Disposition First Posted: 2016-07-11
• Results First Submitted: 2020-09-09
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Results First Posted: 2020-11-13
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R1507 in Combination With Letrozole	RG1507	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.
R1507 in Combination With Letrozole	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.

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response (Part 2)	Up to 14 months

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (Part 2)	Up to 14 months
Pharmacokinetics (PK) Profile (Part 2)	Up to 14 months
Number of Participants With Adverse Events (Part 2)	Up to 14 months