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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: RG1507; Drug: Letrozole

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3300
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
  • Florida
    • Miami, Florida, United States, 33136
  • Georgia
    • Atlanta, Georgia, United States, 30322
  • Missouri
    • Saint Louis, Missouri, United States, 63110
  • Texas
    • Houston, Texas, United States, 77030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: RG1507; R1507 was administered at a dose 16 mg/kg every 3 weeks.; Drug: Letrozole; Letrozole was administered orally at a dose 2.5 mg daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Tumor Response (Part 2)	Up to 14 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2009
• Primary Completion (Actual): March 3, 2010
• Study Completion (Actual): March 3, 2010

Study Registration Dates

• First Submitted: November 21, 2008
• First Submitted That Met QC Criteria: November 21, 2008
• First Posted (Estimate): November 24, 2008

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: NO21161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).