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Immunosuppressant

Monoclonal Antibodies + Cyclosporine + Paclitaxel for Breast Cancer

Phase 1
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 and over
At least 4 weeks since prior chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will use radiolabeled monoclonal antibodies to target and kill cancer cells while sparing normal cells. Cyclosporine and paclitaxel will be used to help the monoclonal antibodies work better. The goal is to learn if this combination treatment is effective and safe.

Who is the study for?
This trial is for adults with recurrent or refractory metastatic breast cancer who've had at least one chemotherapy regimen. They must have good lung and heart function, a certain level of immune response, and no other cancers in the past 5 years (except some skin cancers or treated cervical carcinoma). Pregnant or nursing individuals are excluded.Check my eligibility
What is being tested?
The study tests a combination treatment involving a radiolabeled monoclonal antibody therapy with cyclosporine and paclitaxel to see if it's effective against metastatic breast cancer that has come back or didn't respond to previous treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to the monoclonal antibody, organ damage from cyclosporine, and common chemotherapy-related issues like fatigue, nausea, hair loss, nerve damage from paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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It has been over 4 weeks since my last chemotherapy session.
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My cancer came back or didn't fully go away after my first chemotherapy.
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My breast cancer has spread and was confirmed by a lab test.
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I have undergone at least one chemotherapy treatment for my advanced disease.
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I haven't had radiation on more than a quarter of my bones.
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My tumor cells are positive for a specific protein marker.
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My cancer has spread to other parts of my body.
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I am mostly able to care for myself and carry out daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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Who is running the clinical trial?

University of California, DavisLead Sponsor
908 Previous Clinical Trials
4,704,115 Total Patients Enrolled
15 Trials studying Breast Cancer
1,342,981 Patients Enrolled for Breast Cancer
Carol M. Richman, MDStudy ChairUniversity of California, Davis
2 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Cyclosporine (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT00009763 — Phase 1
Breast Cancer Research Study Groups:
Breast Cancer Clinical Trial 2023: Cyclosporine Highlights & Side Effects. Trial Name: NCT00009763 — Phase 1
Cyclosporine (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00009763 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical approach well-tolerated in patients?

"Power's assessment of this treatment places its safety at a 1, as it is yet to pass Phase 1 trials and thus has limited evidence for efficacy or security."

Answered by AI

Is enrollment currently available for this trial?

"The clinicaltrials.gov database confirms that, though posted on March 1st 2001 and last updated September 19th 2013, this medical trial is presently not enrolling candidates. However, there are currently 2600 other studies seeking participants."

Answered by AI
~15 spots leftby Mar 2025