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

Breast Cancer Clinical Trial

Official title:

An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00796107
• Other study ID #: NO21161
• Status: Terminated
• Phase: Phase 2
• Start date: January 28, 2009
• Est. completion date: March 3, 2010

Study information

• Verified date: October 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 3, 2010
• Est. primary completion date: March 3, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Tumor Response (Part 2)		Up to 14 months
Secondary	Pharmacokinetics (PK) Profile (Part 2)		Up to 14 months
Secondary	Progression-free Survival (Part 2)		Up to 14 months
Secondary	Number of Participants With Adverse Events (Part 2)		Up to 14 months