Completed

Study of MDX-010 in Stage IV Breast Cancer

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What is being tested

MDX-010

Drug
Who is being recruted

Breast Cancer

+ Adenocarcinoma
Over 18 Years
+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2003

See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: April 27, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2003Actual date on which the first participant was enrolled.

This Phase II study is designed to treat patients who have been diagnosed with Stage IV Breast Cancer, which has progressed despite treatment with primary therapies, including hormonal therapy, chemotherapy, and antibody therapy. Thirty-three patients will be treated with the monoclonal antibody MDX-010. The initial antitumor activity profile of MDX-010 will be determined, as well as identification of the induction of any antitumor immunity following the MDX-010 treatment.

Official TitleA Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast 
Principal SponsorBristol-Myers Squibb
Last updated: April 27, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
33 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
Adenocarcinoma
Criteria
9 inclusion criteria required to participate
Provide written informed consent
diagnosed with Stage IV adenocarcinoma that has progressed despite previous therapy
at least 18 years of age
measurable disease defined by RECIST

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8 exclusion criteria prevent from participating
must be disease free from other cancers for at least 5 years
symptomatic or untreated brain metastases
active or history of autoimmune disease
active HIV, HTLV, HBV or HCV infection

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 14 locations
Suspended
Sharp Clinical Oncology ResearchSan Diego, United StatesSee the location
Suspended
Wishard Health ServicesIndianapolis, United States
Suspended
Section of Hematology/Oncology, Indiana Cancer PavilionIndianapolis, United States
Suspended
Indiana University, Clarian Health PartnersIndianapolis, United States
Completed14 Study Centers