METRIC : A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, GPNMB Over-Expressing, Triple Negative Breast Cancer. (The METRIC Study)

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18-75Age 18-75

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase II trial will determine whether CDX-011 is an effective treatment for people with triple negative breast cancer.
 

This trial is treating patients with triple negative breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, GPNMB Over-Expressing, Triple Negative Breast Cancer. (The METRIC Study)

Commercial Sponsor

Celldex Therapeutics

Summary

CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (GPNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death. This study will examine the effectiveness and safety of CDX-011 in patients with advanced TNBC that makes the GPNMB protein. The effect of CDX-011 will be compared to treatment with capecitabine. Eligible patients who enroll in the study will be randomly assigned (by chance) to receive treatment with CDX-011 or with capecitabine. For every three patients enrolled, two will receive CDX-011 and one will receive treatment with capecitabine. All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.

Recruiting Hospitals Read MoreRead more

Epworth Hospital
Richmond
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055

Epworth Freemasons, Medical Oncology
East Melbourne
Ms Felicity Osmond
felicity.osmond@epworth.org.au
03 9936 8055

Not Recruiting Hospitals Read MoreRead more

Closed

Olivia Newton-John Cancer Wellness & Research Centre
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Box Hill Hospital, Breast Oncology
Box Hill
Ms Amy Tang
amy.tang@easternhealth.org.au
03 9091 8804

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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