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CAR T-cell Therapy

TAA-specific CTLs for Breast Cancer (TACTIC Trial)

Phase 2
Waitlist Available
Led By Mothaffar F Rimawi, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any breast cancer patient with metastatic or locally recurrent unresectable disease
Age greater than or equal to 18 and less than or equal to 80 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

TACTIC Trial Summary

This trial is closed to patient enrollment.

Who is the study for?
This trial is for adults aged 18-80 with breast cancer that has returned and is now metastatic or locally advanced and untreatable by surgery. They must have tried at least two treatments, have a life expectancy of 12+ weeks, stable organ function, no severe infections or uncontrolled conditions, not be on steroids or HIV positive, and agree to use effective birth control.Check my eligibility
What is being tested?
The study tests TAA-specific cytotoxic T lymphocytes (TAA-CTLs), an experimental therapy targeting five common tumor-associated antigens (TAAs) in breast cancer cells. The goal is to evaluate the effectiveness and side effects of this new treatment in patients whose cancer has resisted standard therapies.See study design
What are the potential side effects?
While specific side effects are not listed for TAA-CTLs since it's experimental, similar treatments often cause immune reactions, fatigue, fever, chills and risk of infection. Patients' individual experiences may vary based on their condition.

TACTIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer cannot be removed by surgery and has spread.
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I am between 18 and 80 years old.
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My breast cancer is spreading and treatments haven’t worked.
Select...
My kidney function, measured by creatinine, is normal for my age.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
I have tried at least two different treatments for my HER2+ cancer without success.

TACTIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Number of Evaluable Patients With Complete Response or Partial Response or Stable Disease for ≥10 Weeks From the First Infusion (6 Weeks After the Second Infusion) According to the RECIST Criteria
Secondary outcome measures
Median Overall Survival
Median Progression-free Survival

TACTIC Trial Design

1Treatment groups
Experimental Treatment
Group I: TAA-Specific CTLsExperimental Treatment1 Intervention
Patients receiving TAA-specific CTLs as therapy for breast cancer.

Find a Location

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
98,426 Total Patients Enrolled
7 Trials studying Breast Cancer
18,893 Patients Enrolled for Breast Cancer
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,168 Total Patients Enrolled
9 Trials studying Breast Cancer
1,659 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,141 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,348 Patients Enrolled for Breast Cancer

Media Library

TAA-specific CTLs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03093350 — Phase 2
Breast Cancer Research Study Groups: TAA-Specific CTLs
Breast Cancer Clinical Trial 2023: TAA-specific CTLs Highlights & Side Effects. Trial Name: NCT03093350 — Phase 2
TAA-specific CTLs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03093350 — Phase 2

Frequently Asked Questions

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

To what degree is the use of TAA-specific CTLs secure for individuals?

"We evaluated the risk associated with TAA-specific CTLs to be a 2, meaning that while safety has been established in some form, there is no evidence of efficacy."

Answered by AI

Are any opportunities available to the public to partake in this experiment?

"Clinicaltrials.gov has verified that this medical trial is no longer recruiting, as the study was initially posted on October 10th 2017 and its information was last reviewed on May 20th 2022. Even though applications for participation in this particular experiment are closed, there are 2596 other clinical trials presently looking for volunteers."

Answered by AI

Is the age limit for participants in this research higher than sixty years old?

"Eligible participants of this trial must fall between the age range of 18 to 80. There are 74 studies available for those younger than 18, and 2501 trials accessible for individuals over 65 years in age."

Answered by AI

Do I qualify to join the experiment?

"This clinical trial is seeking 12 breast cancer patients aged between 18 and 80."

Answered by AI
~2 spots leftby Apr 2025