Zotatifin + Carboplatin for Breast Cancer

BL
Overseen ByBora Lim, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

To find the optimal (best) recommended dose of zotatifin and carboplatin to treat patients with metastatic or recurrent TNBC.

Who Is on the Research Team?

BL

Bora Lim, MD

Principal Investigator

UT MD Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with advanced or recurrent triple negative breast cancer (TNBC) who have already tried at least two treatments, or those with inflammatory breast cancer. Participants must have good organ function and not be pregnant. People with certain heart, lung, immune conditions, allergies to study drugs, or active infections cannot join.

Inclusion Criteria

My breast cancer is triple negative or inflammatory, and I meet the required treatment history.
I am 18 years old or older.
I am not pregnant, as confirmed by a recent pregnancy test.
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Exclusion Criteria

History of allergic reactions to compounds similar to carboplatin or zotatifin
I have had interstitial lung disease or non-infectious pneumonitis.
I have an autoimmune disease needing strong immune-suppressing drugs in the past 2 years.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zotatifin and carboplatin to determine the optimal biologic dose

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Zotatifin

Trial Overview

The study is testing different doses of zotatifin combined with carboplatin in people whose TNBC has come back or spread after other treatments. The goal is to find the safest and most effective dose combination.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ZOT-CAR: Phase 1b Treatment with Zotatifin + CarboplatinExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials
55
Recruited
98,900+

SJP Biotec

Collaborator