← Back to Search

Monoclonal Antibodies

Cohort 4: HR-positive, HER2 IHC 0 for Breast Cancer

Q: What is the current number of participants being recruited for this clinical investigation?

Indeed, the information found on clinicaltrials.gov indicates that this trial is actively seeking participants. The initial posting was made on December 30th, 2023 and the most recent update occurred on January 2nd, 2024. In total, the trial aims to recruit 250 individuals from a single site.

Q: Are prospective patients still eligible to participate in this ongoing medical study?

According to the information provided on clinicaltrials.gov, this study is actively seeking participants. The trial was initially posted on December 30th, 2023 and recently updated on January 2nd, 2024.

Q: Has the FDA officially authorized the use of Cohort 4, which consists of HR-positive patients with HER2 IHC 0?

Since this trial is in Phase 3, our team at Power rates the safety of Cohort 4 (HR-positive, HER2 IHC 0) as a score of 3. This rating indicates that there is evidence supporting both efficacy and multiple rounds of data confirming its safety.

Phase 3

Recruiting

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

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

Must have

Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above.

Is hormone receptor-negative or hormone receptor-positive.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 24 months

Awards & highlights

Study Summary

This trial is testing a new treatment called trastuzumab deruxtecan (T-DXd) in people with a specific type of breast cancer. The goal is to see if this treatment

Who is the study for?

This trial is for adults with unresectable/metastatic breast cancer that's either hormone receptor-negative or -positive but HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 IHC 0. Participants must not have been previously treated with anti-HER2 therapy in the metastatic setting and should have had one to two prior lines of therapy for their metastatic disease.Check my eligibility

What is being tested?

The study tests Trastuzumab Deruxtecan (T-DXd) on patients with specific types of breast cancer. It aims to assess how safe and effective T-DXd is in treating those whose tumors are low in a protein called HER2, which can affect cancer growth.See study design

What are the potential side effects?

While the side effects of T-DXd will be monitored during the trial, they may include nausea, fatigue, hair loss, lowered blood cell counts leading to increased infection risk, potential heart issues, and possible lung problems.

Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer is confirmed as HER2-low or HER2-negative.

Select...

My cancer may or may not respond to hormones.

Select...

My breast cancer cannot be removed by surgery and/or has spread.

Select...

My cancer was never previously tested positive for HER2.

Select...

I have received 1 or 2 treatments for my cancer after it spread.

Select...

I have never had anti-HER2 therapy for cancer that has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT)

Secondary outcome measures

Mean Change From Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Index Score

Mean Change From Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)

Mean Change from Baseline in EuroQol Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L)

+11 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4: HR-positive, HER2 IHC 0Experimental Treatment1 Intervention

Participants with HR-positive HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.

Group II: Cohort 3: HR-positive, HER2-lowExperimental Treatment1 Intervention

Participants with HR-positive HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd. Participants must also have recurrent disease <2 years from the initiation of adjuvant ET or have disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor or have disease progression within the first 12 months of CDK4/6 in the first line metastatic setting.

Group III: Cohort 2: HR-negative, HER2 IHC 0Experimental Treatment1 Intervention

Participants with HR-negative HER2 IHC 0 unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.

Group IV: Cohort 1: HR-negative, HER2-lowExperimental Treatment1 Intervention

Participants with HR-negative HER2-low unresectable and/or metastatic breast cancer who have received at least one and at most two prior lines of therapy in the metastatic setting will receive T-DXd.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab Deruxtecan

2021

Completed Phase 3

~510

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daiichi SankyoLead Sponsor

393 Previous Clinical Trials

416,051 Total Patients Enrolled

25 Trials studying Breast Cancer

17,377 Patients Enrolled for Breast Cancer

Daiichi Sankyo, Inc.Lead Sponsor

389 Previous Clinical Trials

419,908 Total Patients Enrolled

27 Trials studying Breast Cancer

19,352 Patients Enrolled for Breast Cancer

AstraZenecaIndustry Sponsor

4,272 Previous Clinical Trials

288,612,425 Total Patients Enrolled

173 Trials studying Breast Cancer

1,246,089 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

What is the current number of participants being recruited for this clinical investigation?

"Indeed, the information found on clinicaltrials.gov indicates that this trial is actively seeking participants. The initial posting was made on December 30th, 2023 and the most recent update occurred on January 2nd, 2024. In total, the trial aims to recruit 250 individuals from a single site."

Answered by AI

Are prospective patients still eligible to participate in this ongoing medical study?

"According to the information provided on clinicaltrials.gov, this study is actively seeking participants. The trial was initially posted on December 30th, 2023 and recently updated on January 2nd, 2024."

Answered by AI

Has the FDA officially authorized the use of Cohort 4, which consists of HR-positive patients with HER2 IHC 0?

"Since this trial is in Phase 3, our team at Power rates the safety of Cohort 4 (HR-positive, HER2 IHC 0) as a score of 3. This rating indicates that there is evidence supporting both efficacy and multiple rounds of data confirming its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

2023. "Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05950945.