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Monoclonal Antibodies

Valemetostat + Trastuzumab Deruxtecan for Breast Cancer

Phase 1

Recruiting

Led By Naoto Ueno, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Is willing to provide fresh tumor tissue via tumor biopsy if safely accessible

Has been treated with at least 1 prior line of chemotherapy in the metastatic or locally progressive setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 2-3 years.

Awards & highlights

Study Summary

This trial will help find the right dose of a drug to treat metastatic breast cancer with low-to-no HER2 expression.

Who is the study for?

This trial is for adults with metastatic breast cancer that expresses low levels of HER2 and who have already tried at least one chemotherapy. They must be in good physical condition, not planning to become pregnant, willing to use birth control if necessary, and able to provide a tumor tissue sample. People with serious health issues, brain metastases requiring steroids, uncontrolled infections or diseases like HIV/hepatitis B/C, or those who've had certain treatments are excluded.Check my eligibility

What is being tested?

The study aims to determine the safe dosage when combining valemetostat with trastuzumab deruxtecan in patients whose breast cancer has low HER2 expression. It's an early-phase trial focusing on finding the right balance of these two drugs for effective treatment.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related responses similar to allergic reactions, fatigue from treatment burden on the body's resources, digestive disturbances due to drug interactions with gut flora or mucosa irritation.

Eligibility Criteria

Inclusion Criteria

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

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I am willing to undergo a biopsy for my cancer if it's safe.

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I have received at least one chemotherapy treatment for my cancer after it spread or got worse.

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My breast cancer is HER2 low according to the Ventana test.

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My breast cancer cannot be removed by surgery.

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I am fully active or can carry out light work.

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I have taken a pregnancy test in the last 72 hours and it was negative.

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My hormone-positive cancer has not improved with hormone therapy.

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My organ functions are within normal ranges according to recent tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 2-3 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 2-3 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 2-3 years. 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 Overall Response Rate (ORR)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

Participants will only receive 1 dose level of valemetostat.

Group II: Group 1Experimental Treatment2 Interventions

Participants will receive the same drugs at the same schedule, and the same dose of trastuzumab deruxtecan

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab deruxtecan

2022

Completed Phase 2

~400

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor

392 Previous Clinical Trials

416,189 Total Patients Enrolled

25 Trials studying Breast Cancer

17,590 Patients Enrolled for Breast Cancer

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,359 Total Patients Enrolled

147 Trials studying Breast Cancer

63,249 Patients Enrolled for Breast Cancer

Daiichi Sankyo, Inc.Industry Sponsor

389 Previous Clinical Trials

420,121 Total Patients Enrolled

27 Trials studying Breast Cancer

19,565 Patients Enrolled for Breast Cancer

Media Library

Trastuzumab deruxtecan (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05633979 — Phase 1

Breast Cancer Research Study Groups: Group 1, Group 2

Breast Cancer Clinical Trial 2023: Trastuzumab deruxtecan Highlights & Side Effects. Trial Name: NCT05633979 — Phase 1

Trastuzumab deruxtecan (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633979 — Phase 1

Frequently Asked Questions

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

How reliable is Group 1 when it comes to human safety?

"Our risk assessment of Group 1 yielded a score of 1, as this is an early-phase trial with minimal supporting evidence for safety and efficacy."

Answered by AI

Is this research endeavor accepting new participants at present?

"As per the information present on clinicaltrials.gov, this clinical trial is no longer enrolling participants; it was initially posted on May 31st of 2023 and last updated November 21st 2022. Although this particular experiment has come to a close, there are still 2,604 other trials looking for candidates at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer

2023. "Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05633979.