NCT00087958|CompletedPhase 2

Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment

Phase II Multi-Center, Open-Label, Non-Randomized Study of Intravenous RPR109881 Given Every 3 Weeks in Patients With Metastatic Breast Cancer Progressing After Therapy With Anthracyclines, Taxanes and Capecitabine

Sanofi ClinicalTrials.gov

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3 other identifiers

EFC6088XRP9881B/2001EUDRACT : 2004-000572-14

Study Type

interventional

Target

168

Locations

15 countries

Sites

Timeline

RegisteredJul 2004

StartedAug 2004

CompletionApr 2009

Brief Summary

The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.

Trial Health

On Track

Trial Health Score

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

Enrollment

168

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline

Completed

Started Aug 2004

Typical duration for phase_2 breast-cancer

Geographic Reach

15 countries

15 active sites

Status

completed

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

4.7 years study duration

First Submitted

Initial submission to the registry

July 16, 2004

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 20, 2004

Completed

12 days until next milestone

Study Start

First participant enrolled

August 1, 2004

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed

2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed

Last Updated

May 1, 2009

Status Verified

April 1, 2009

Enrollment Period

2.5 years

First QC Date

July 16, 2004

Last Update Submit

April 30, 2009

Conditions

Breast Cancer

Keywords

Metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors

Secondary Outcomes (3)

Progression free survival, overall survival, composite event of CR, PR and stable disease > or = to 12 weeks
Time to tumor response and duration of response.
Safety analyses based on incidence, severity, chronicity and cumulative nature of TEAEs.

Interventions

XRP9881DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

In order to be eligible for this trial you must:
Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery.
Have received previous treatment with anthracyclines (e.g. doxorubicin \[Adriamycin or Doxil\] or epirubicin \[Ellence\]), taxanes (paclitaxel \[Taxol or Abraxane\] or docetaxel \[Taxotere\]) and capecitabine (e.g. Xeloda) for your breast cancer and your doctor has determined that these treatments are no longer of benefit to you.
Be at least 18 years of age
Not be taking other treatments for your cancer at the time you enter the trial.
Not be pregnant
Additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (lab tests, CT scans).

You may not qualify if:

None listed here. Can be discussed with your doctor.

Contact the study team to confirm eligibility.