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

Roche

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: RG1507; Drug: Letrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796107

NO21161

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

R1507 in Combination With Letrozole

Experimental group

Description:

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.

Treatment:

Drug: Letrozole

Drug: RG1507