What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as trastuzumab deruxtecan, can cause side effects including nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, and anemia, with serious risks like interstitial lung disease and neutropenia. Chemotherapy often leads to hair loss, nausea, fatigue, and increased infection risk. Hormone therapies, like tamoxifen, may result in hot flashes, vaginal dryness, and a higher risk of blood clots. Aromatase inhibitors, another targeted therapy, can cause bone density loss and cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that target the HER2 receptor, similar to trastuzumab deruxtecan. Notable approvals include trastuzumab (Herceptin), pertuzumab (Perjeta), and ado-trastuzumab emtansine (T-DM1). Trastuzumab deruxtecan (T-DXd) itself is approved for HER2-positive metastatic breast cancer, showing significant efficacy in patients who have progressed on prior HER2-targeted therapies. Additionally, neratinib in combination with capecitabine and lapatinib plus capecitabine are approved for patients who have received multiple prior anti-HER2 regimens. These treatments aim to improve progression-free survival and overall survival in patients with advanced breast cancer.

What other types of research exist?

Promising novel alternatives to Valemetostat for breast cancer patients in 2024 include: 1) Elacestrant, an oral selective estrogen receptor degrader (SERD) showing efficacy in ER-positive/HER2-negative breast cancer. 2) Sacituzumab Govitecan, an antibody-drug conjugate targeting Trop-2, approved for metastatic triple-negative breast cancer. 3) Alpelisib, a PI3K inhibitor used in combination with endocrine therapy for PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. These agents represent advancements in targeted therapy and may offer enhanced efficacy in specific breast cancer subtypes.

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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

Must not have

Subjects with symptomatic brain metastases, or subjects with treated brain metastases that are no longer symptomatic but who require treatment with steroids

Has known human immunodeficiency virus (HIV) infection or active hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new drug called valemetostat with an existing drug, trastuzumab deruxtecan, for patients with a specific type of breast cancer that doesn't respond well to usual treatments. The combination aims to stop cancer cell growth and deliver chemotherapy directly to the cancer cells.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases but am not currently experiencing symptoms.

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I have HIV or active hepatitis B or C.

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I have an autoimmune or inflammatory condition affecting my lungs.

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I have or had lung inflammation treated with steroids, or it might be seen in my scans.

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I do not have an active severe infection needing IV drugs.

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I have been treated with anti-HER2 therapy before.

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My cancer has spread to my brain or spinal cord.

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I am currently taking medication that strongly affects liver enzymes.

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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I have not had any cancer, except for treatable local cancers, in the past 2 years.

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I do not have serious heart problems.

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I have had surgery to remove one entire lung.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

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

~580

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments often target specific molecular pathways to inhibit cancer cell growth and proliferation. Trastuzumab deruxtecan is an antibody-drug conjugate that combines trastuzumab, which targets the HER2 receptor on cancer cells, with a cytotoxic agent that kills these cells upon internalization. This dual mechanism enhances the specificity and efficacy of the treatment. Valemetostat, an EZH1/2 inhibitor, potentially enhances the efficacy of trastuzumab deruxtecan by sensitizing cancer cells or enhancing the therapeutic effect, making the cancer cells more susceptible to the cytotoxic action of trastuzumab deruxtecan. Understanding these mechanisms is crucial for breast cancer patients as it allows for more personalized and effective treatment strategies, potentially improving outcomes and reducing side effects.

Overcoming recurrence risk: extended adjuvant endocrine therapy.

Find a Location

Who is running the clinical trial?

Daiichi SankyoIndustry Sponsor

401 Previous Clinical Trials

447,023 Total Patients Enrolled

25 Trials studying Breast Cancer

17,627 Patients Enrolled for Breast Cancer

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,664 Total Patients Enrolled

147 Trials studying Breast Cancer

63,240 Patients Enrolled for Breast Cancer

Daiichi Sankyo, Inc.Industry Sponsor

389 Previous Clinical Trials

422,563 Total Patients Enrolled

27 Trials studying Breast Cancer

19,602 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

~25 spots leftby Dec 2030

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