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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RG1507
Letrozole
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R1507 in Combination With Letrozole

Arm 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.

Outcomes

Primary Outcome Measures

Objective Tumor Response (Part 2)

Secondary Outcome Measures

Pharmacokinetics (PK) Profile (Part 2)
Progression-free Survival (Part 2)
Number of Participants With Adverse Events (Part 2)

Full Information

First Posted
November 21, 2008
Last Updated
October 20, 2020
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00796107
Brief Title
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to the discontinuation of compound development, this study has been terminated.
Study Start Date
January 28, 2009 (Actual)
Primary Completion Date
March 3, 2010 (Actual)
Study Completion Date
March 3, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R1507 in Combination With Letrozole
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
RG1507
Intervention Description
R1507 was administered at a dose 16 mg/kg every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Letrozole was administered orally at a dose 2.5 mg daily.
Primary Outcome Measure Information:
Title
Objective Tumor Response (Part 2)
Time Frame
Up to 14 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) Profile (Part 2)
Time Frame
Up to 14 months
Title
Progression-free Survival (Part 2)
Time Frame
Up to 14 months
Title
Number of Participants With Adverse Events (Part 2)
Time Frame
Up to 14 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

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

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