A Multi Cohort Translational Research Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

Study investigates why breast cancer treatments stop working

NCT: NCT06274515 · Status: RECRUITING · Phase: Phase 4 · Sponsor: Hoffmann-La Roche · Started: 2024-04-02 · Est. Completion: 2026-09-30

Plain English Summary

A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies is a Phase 4 clinical trial sponsored by Hoffmann-La Roche studying Breast Cancer. This study looks at how breast cancer becomes resistant to common treatments. It is for patients with HER2-positive, hormone-receptor-positive, or triple-negative breast cancer. Participation involves providing tumor tissue and blood samples. There are no alternative treatments offered within this study; it focuses on understanding resistance. The trial aims to enroll 320 participants.

Official Summary

This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have HER2-positive, hormone-receptor-positive, or triple-negative breast cancer that is growing. You must be willing to have a biopsy or surgery to get a tumor sample and a blood draw. You cannot join if you have bleeding disorders or other serious medical conditions that would make the procedure unsafe. You cannot have started a new cancer treatment recently. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study will measure changes in specific proteins and genes in your tumor and blood to understand how resistance develops, helping doctors find new ways to overcome it. The specific primary outcome measures are: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) (At least 6 months); Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2) (At least 6 months); Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) (At least 6 months); Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3) (Less than 6 months); Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3) (Less than 6 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 is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial is important because it aims to uncover why some breast cancers stop responding to treatment, which could lead to better therapies for patients. This research targets Breast Cancer, where improved treatment options are needed.

Investor Insight

This study by Roche focuses on a critical unmet need in breast cancer treatment, potentially leading to new drug development and a significant market opportunity. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor if this study is right for you and what risks are involved with a biopsy or surgery. You will need to provide tumor tissue (from a biopsy or surgery) and blood samples. Your doctor will monitor your cancer's progress to see if it's growing or changing. 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

Interventions

Primary Outcomes

Full Eligibility Criteria

General Inclusion Criteria:

* Willingness to undergo a procedure to obtain tumor tissue (e.g. biopsy) and blood draw
* Diagnosis of HER2+, HR+ (for cohort R1) or triple negative breast cancer (for cohort T1) as per local assessment
* Availability of an archival tumor tissue (most recent pre-treatment tumor tissue is preferred)
* Unequivocally growing tumor lesion (progressive lesion) that is accessible for resection, excision or core needle biopsy
* Discontinuation of prior anti-cancer treatment outlined below should not be longer than 4 weeks from participation in this study

Inclusion criteria for participants in the cohorts studying acquired resistance

* Participant had undergone regular monitoring for disease progression as per local practice (preferably every 3-6 months) while on most recent breast cancer therapy
* Accessible tumor lesion that newly appeared or a lesion that started to regrow while the participant was at least 6 months on therapy

Inclusion criteria for participants in the cohort studying primary resistance

* Accessible tumor lesion that continued to increase in size or a newly appearing lesion (as confirmed by routine tumor assessment) while treated for at least 4 weeks but less than 6 months on therapy

Exclusion Criteria:

* Any risks factors that increase the risk of complications associated with the procedure to obtain tumor tissue (e.g. bleeding disorders)
* Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
* Participant has started treatment with subsequent anti-cancer therapy
* Participants whose progressive tumor lesion that is targeted for biopsy/resection is in the bone
* Discontinuation of treatment was due to a reason other than disease progression

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06274515?

NCT06274515 is a Phase 4 INTERVENTIONAL study titled "A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies." It is currently recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 320 participants.

What conditions does NCT06274515 study?

This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.

What treatments are being tested in NCT06274515?

The interventions being studied include: Tumor Tissue and Blood Draw (PROCEDURE). Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.

What does Phase 4 mean for NCT06274515?

Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.

What is the current status of NCT06274515?

This trial is currently "Recruiting." It started on 2024-04-02. The estimated completion date is 2026-09-30.

Who is sponsoring NCT06274515?

NCT06274515 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06274515?

The trial aims to enroll 320 participants. The trial is currently recruiting and accepting new participants.

How is NCT06274515 designed?

This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06274515?

The primary outcome measures are: Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) (At least 6 months); Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2) (At least 6 months); Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) (At least 6 months); Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3) (Less than 6 months); Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3) (Less than 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06274515 being conducted?

This trial is being conducted at 20 sites, including Anderlecht; Brasschaat; Liège; Roeselare and 16 more sites (Belgium, Denmark, Finland).

Where can I find official information about NCT06274515?

The official record for NCT06274515 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06274515. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06274515 testing in simple terms?

This study looks at how breast cancer becomes resistant to common treatments. It is for patients with HER2-positive, hormone-receptor-positive, or triple-negative breast cancer.

Why is this trial significant?

This trial is important because it aims to uncover why some breast cancers stop responding to treatment, which could lead to better therapies for patients.

What are the potential risks of participating in NCT06274515?

The main risks involve complications from a biopsy or surgery, such as bleeding or infection. There's a small risk that the procedure might not get enough tissue for analysis. The study itself does not involve new treatments, so the risks are primarily related to the sample collection. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06274515?

Ask your doctor if this study is right for you and what risks are involved with a biopsy or surgery. You will need to provide tumor tissue (from a biopsy or surgery) and blood samples. Your doctor will monitor your cancer's progress to see if it's growing or changing. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06274515 signal from an investment perspective?

This study by Roche focuses on a critical unmet need in breast cancer treatment, potentially leading to new drug development and a significant market opportunity. This is a Phase 4 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves providing tumor tissue and blood samples. 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.

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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.