Trial purpose
Cancer treatment
Tumor type
Breast
Age
18 - 75
Clinical summary
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.
Conditions
This trial is treating people with triple negative breast cancer
Eligibility
Inclusion
Among other criteria, patients must meet all of the following conditions to be eligible for the study:
-
Diagnosed with metastatic (i.e., cancer that has spread) TNBC
- minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by immunohistochemistry
- HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell
- Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.
- Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.
- Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.
- Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).
- ECOG performance status of 0 - 1.
- Adequate bone marrow, liver and renal function.
Exclusion
Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
- Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.
- Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
- Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
- Significant cardiovascular disease.
- Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.
- Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
- Chronic use of systemic corticosteroids.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Celldex Therapeutics
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)
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