NCT00796107

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 28, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2010

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

November 13, 2020

Completed
Last Updated

November 13, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

November 21, 2008

Results QC Date

September 9, 2020

Last Update Submit

October 20, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Tumor Response (Part 2)

    Up to 14 months

Secondary Outcomes (3)

  • 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

Study Arms (1)

R1507 in Combination With Letrozole

EXPERIMENTAL

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: RG1507Drug: Letrozole

Interventions

RG1507DRUG

R1507 was administered at a dose 16 mg/kg every 3 weeks.

R1507 in Combination With Letrozole
LetrozoleDRUG

Letrozole was administered orally at a dose 2.5 mg daily.

R1507 in Combination With Letrozole

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal female patients;
  • stage IV or locally advanced breast cancer;
  • measurable disease;
  • letrozole failure (Part 2);
  • Eastern Cooperative Oncology Group (ECOG) performance status \<=2.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Birmingham, Alabama, 35294-3300, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20007, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

RG-1507 monoclonal antibodyLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Phase 2 of this study was not conducted.

Results Point of Contact

Title
Study Director
Organization
Hoffmann-La Roche, Ltd.
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

January 28, 2009

Primary Completion

March 3, 2010

Study Completion

March 3, 2010

Last Updated

November 13, 2020

Results First Posted

November 13, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

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).

Locations

US(6)