QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
New trial seeks to improve treatment for HER2-low metastatic breast cancer
Plain English Summary
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer is a Not Applicable clinical trial sponsored by Abramson Cancer Center at Penn Medicine studying HER2-positive Metastatic Breast Cancer. This study tests a new method to measure HER2 protein levels in metastatic breast cancer to better predict treatment response. It is for patients with HER2-low metastatic breast cancer who are about to start or have recently started treatment with a specific drug called T-DXd (Enhertu). Participation involves providing leftover tumor tissue from a biopsy for advanced testing. There are no direct alternative treatments being tested in this study; it focuses on improving the selection of existing treatments. The trial aims to enroll 200 participants.
Official Summary
This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults (18 years or older) with metastatic breast cancer that has a low level of HER2 expression (1+ by IHC). Patients must have measurable disease and be starting or have recently started T-DXd (Enhertu) treatment. Patients with bone-only disease or active brain metastases may be eligible. Individuals with concurrent HER2-overexpressing breast cancer (3+ or 2+ with FISH amplified) are not eligible. This trial is studying HER2-positive Metastatic Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how many patients with HER2-low metastatic breast cancer respond to T-DXd treatment, indicating the effectiveness of the drug in this specific patient group. The specific primary outcome measures are: Real-World Objective Response Rate (from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to refine how we identify patients who will benefit most from T-DXd, a targeted therapy for breast cancer, addressing a gap in accurately classifying HER2-low tumors This research targets HER2-positive Metastatic Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial focuses on optimizing the use of T-DXd, a drug with significant market potential in breast cancer, by improving patient selection for HER2-low disease, potentially increasing its efficacy a
Is This Trial Right for Me?
Ask your doctor if your breast cancer is considered HER2-low and if you might be a candidate for this study. Participation requires providing a small sample of leftover tumor tissue from a recent biopsy. The study involves advanced testing of your tumor tissue to measure HER2 levels. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 200 participants
Interventions
- DIAGNOSTIC_TEST: CE-10-IVD — Leftover tumor tissue from a routine biopsy will be sent for analysis.
Primary Outcomes
- Real-World Objective Response Rate (from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months)
Secondary Outcomes
- Real-World Progression Free Survival (from date of first dose of T-DXd to date of last dose of T-DXd for each.Up to 100 months)
- Real-World Progression Free Survival and Objective Response Rate by estrogen receptor expression (from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months)
- Threshold for HER2 QIF and/or mRNA levels (from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months)
- Association between combined mRNA + QIF and real-world Objective Response Rate (from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months)
Full Eligibility Criteria
Inclusion Criteria: * Women and men age \> 18 years * Metastatic breast cancer, histologically- confirmed. Any estrogen receptor (ER) status is allowed. ER status will be determined by local laboratory assessment utilizing ASCO/CAP guidelines. * Primary and/or metastatic tumor with 1+ level of expression of HER2 by immunohistochemistry as determined by local laboratory assessment utilizing ASCO/CAP guidelines. * Measurable disease by cross-sectional imaging at the start of treatment. Patients with measurable bone-only disease or active brain metastases are eligible. * Archival tissue available for biomarker assessment. One specimen should be the most recent metastatic biopsy. If HER2 1+ status was determined on a different specimen (either primary or metastatic tissue), that specimen is also required. Samples obtained from bone metastases that were processed via decalcification methods are not eligible. * Intention to initiate therapy with T-DXd (Enhertu) at FDA-approved dose and schedule as next line of therapy. If T-DXd was already initiated, patients must be registered within 30 days of initiation. * Ability to provide informed consent Exclusion Criteria: * Concurrent Her2-overexpressing metastatic breast cancer (as confirmed by a metastatic biopsy with IHC 3+ or IHC 2+ with FISH amplified as per standard ASCO/CAP guidelines)
Trial Locations
- University of California San Francisco Medical Center, San Francisco, California, United States
- Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States
- Smilow Cancer Hospital Care Center, Fairfield, Connecticut, United States
- Smilow Cancer Hospital at Glastonbury, Glastonbury, Connecticut, United States
- Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, United States
- Smilow Cancer Hospital Care Center, Guilford, Connecticut, United States
- Smilow Cancer Hospital at Saint Francis, Hartford, Connecticut, United States
- Yale-New Haven Hospital North Haven Medical Center, New Haven, Connecticut, United States
- Yale Cancer Center, New Haven, Connecticut, United States
- Smilow Cancer Hospital Care Center at Long Ridge, Stamford, Connecticut, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06551116?
NCT06551116 is a Not Applicable OBSERVATIONAL study titled "QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer." It is currently recruiting and is sponsored by Abramson Cancer Center at Penn Medicine. The trial targets enrollment of 200 participants.
What conditions does NCT06551116 study?
This trial investigates treatments for HER2-positive Metastatic Breast Cancer. The primary condition under study is HER2-positive Metastatic Breast Cancer.
What treatments are being tested in NCT06551116?
The interventions being studied include: CE-10-IVD (DIAGNOSTIC_TEST). Leftover tumor tissue from a routine biopsy will be sent for analysis.
What does Not Applicable mean for NCT06551116?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06551116?
This trial is currently "Recruiting." It started on 2024-10-10. The estimated completion date is 2029-09-01.
Who is sponsoring NCT06551116?
NCT06551116 is sponsored by Abramson Cancer Center at Penn Medicine. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06551116?
The trial aims to enroll 200 participants. The trial is currently recruiting and accepting new participants.
How is NCT06551116 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06551116?
The primary outcome measures are: Real-World Objective Response Rate (from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06551116 being conducted?
This trial is being conducted at 20 sites, including San Francisco, California; Derby, Connecticut; Fairfield, Connecticut; Glastonbury, Connecticut and 16 more sites (United States).
Where can I find official information about NCT06551116?
The official record for NCT06551116 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06551116. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06551116 testing in simple terms?
This study tests a new method to measure HER2 protein levels in metastatic breast cancer to better predict treatment response. It is for patients with HER2-low metastatic breast cancer who are about to start or have recently started treatment with a specific drug called T-DXd (Enhertu).
Why is this trial significant?
This trial matters because it aims to refine how we identify patients who will benefit most from T-DXd, a targeted therapy for breast cancer, addressing a gap in accurately classifying HER2-low tumors
What are the potential risks of participating in NCT06551116?
The main risk is related to the biopsy procedure itself, which carries standard risks like bleeding or infection. Potential side effects are primarily related to the T-DXd treatment, which can include fatigue, nausea, hair loss, and low blood counts. The tissue testing is considered low risk, but there's a small chance the sample may not be sufficient for analysis. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06551116?
Ask your doctor if your breast cancer is considered HER2-low and if you might be a candidate for this study. Participation requires providing a small sample of leftover tumor tissue from a recent biopsy. The study involves advanced testing of your tumor tissue to measure HER2 levels. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06551116 signal from an investment perspective?
This trial focuses on optimizing the use of T-DXd, a drug with significant market potential in breast cancer, by improving patient selection for HER2-low disease, potentially increasing its efficacy a This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing leftover tumor tissue from a biopsy for advanced testing. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.