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Tyrosine Kinase Inhibitor

Taletrectinib for Breast Cancer

Phase 2

Waitlist Available

Led By Megan Kruse

Research Sponsored by Megan Kruse, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior Therapy requirements: For estrogen receptor positive (ER+) participants: prior endocrine therapy with a CDK4/6 inhibitor and at least 1 chemotherapy or antibody drug conjugate in the metastatic setting. For estrogen receptor negative (ER-) participants: at least 2 prior lines of chemotherapy or antibody drug conjugate received in the metastatic setting

Presence of CDH1 mutation as confirmed by any commercially available next generation sequencing (NGS) testing on tumor tissue or liquid biopsy specimens

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after the final dose of the study drug

Awards & highlights

Study Summary

This trial is testing a drug called talectrectinib to see if it is safe and well-tolerated in treating a specific type of breast cancer called Stage IV ILC with CDH1

Who is the study for?

This trial is for individuals with Stage IV invasive lobular breast cancer that has a CDH1 mutation. Participants should have previously undergone treatment without success.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a medication called Taletrectinib in treating advanced breast cancer with specific genetic changes.See study design

What are the potential side effects?

While the side effects of Taletrectinib will be closely monitored, they may include typical drug reactions such as nausea, fatigue, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has a CDH1 mutation confirmed by a specific test.

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I am 18 years old or older.

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I have a confirmed diagnosis of invasive lobular carcinoma and my breast cancer has spread.

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My cancer is HER2 negative based on specific tests.

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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after the final dose of the study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after the final dose of the study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after the final dose of the study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR) as measured by RECIST v1

Secondary outcome measures

Clinical Benefit Rate

Duration Of Response(DOR)

Overall Quality Of Life(QOL) with EORTC QLQ-C30 assessments

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TaletrectinibExperimental Treatment1 Intervention

Taletrectinib 600mg will be given po daily every day within 2 hours of meals on days 1-21, on a 21-day cycle. Study drug will be given until intolerance, consent withdrawal, progression per RECIST 1.1, or death (i.e., no maximum number of cycles).

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Megan Kruse, MDLead Sponsor

AnHeart Therapeutics Inc.Industry Sponsor

10 Previous Clinical Trials

747 Total Patients Enrolled

Megan KrusePrincipal InvestigatorCleveland Clinic Foundation, Case Comprehensive Cancer Center

Frequently Asked Questions

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

Has taletrectinib received the official endorsement of the Food and Drug Administration (FDA)?

"Based on our assessment at Power, the safety of Taletrectinib is rated as 2. This evaluation reflects the fact that this trial is currently in Phase 2, with available data demonstrating some level of safety but no evidence yet supporting efficacy."

Answered by AI

Are patients currently eligible to participate in this ongoing clinical trial?

"Based on the information provided by clinicaltrials.gov, this particular study is currently not seeking participants. The trial was first posted on April 1st, 2024 and its most recent update occurred on January 10th, 2024. However, it's worth noting that there are presently 2620 other ongoing clinical trials actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC)

Megan Kruse, MD 2024. "Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06214793.