An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

New breast cancer trial tests promising drug for advanced HR+/HER2- disease

NCT: NCT07060807 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Merck Sharp & Dohme LLC · Started: 2025-07-21 · Est. Completion: 2033-07-14

Plain English Summary

A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Breast Neoplasms. This study tests a new drug called patritumab deruxtecan against standard treatments for advanced hormone-receptor-positive, HER2-negative breast cancer. It is for patients whose cancer has spread or cannot be removed by surgery and has not responded to previous treatments, including hormone therapy and CDK4/6 inhibitors. Participants will be randomly assigned to receive either patritumab deruxtecan or the treatment their doctor chooses, which could be chemotherapy or another drug. Alternative treatments include various chemotherapy drugs, hormone therapies, and targeted therapies depending on the patient's specific situation and prior treatments. The trial aims to enroll 1000 participants.

Official Summary

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with hormone-receptor-positive, HER2-negative breast cancer that has spread or cannot be surgically removed. Must have had cancer progression or recurrence after prior treatment with a CDK4/6 inhibitor and endocrine therapy. Patients must have measurable disease and be in good general health (ECOG performance status 0 or 1). Cannot have certain conditions like active brain metastases, significant heart or lung issues, or prior treatment with similar drugs. This trial is studying Breast Neoplasms, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The study will measure if patients live longer overall or if their cancer grows more slowly, meaning the new drug could help extend life or control the disease for a longer period. The specific primary outcome measures are: Progression Free Survival (PFS) (Up to approximately 45 months); Overall Survival (OS) (Up to approximately 85 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 trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for new treatments in advanced HR+/HER2- breast cancer that has become resistant to existing therapies, potentially offering a new option for patients with limited As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Breast Neoplasms, where improved treatment options are needed.

Investor Insight

This trial targets a large market of patients with advanced breast cancer, aiming to establish patritumab deruxtecan as a new standard of care, which could lead to significant commercial success if ap Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your cancer is HR+/HER2- and if you have progressed on CDK4/6 inhibitor plus endocrine therapy. Understand that you will be randomly assigned to one of two treatment groups, and you may not know which one you are receiving. Be prepared for regular clinic visits for treatment, monitoring, and potential side effects. 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

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a diagnosis of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent
* Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions)
* Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET) with one of the following:

  * Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting, or
  * Disease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor
* Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
* Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has breast cancer amenable to treatment with curative intent
* Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator
* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option
* Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications
* Has any of the following: a pulse oximeter reading \<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has ≥Grade 2 peripheral neuropathy.
* Has clinically significant corneal disease
* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
* Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy
* Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered
* Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening
* Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients
* Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07060807?

NCT07060807 is a Phase 3 INTERVENTIONAL study titled "A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 1000 participants.

What conditions does NCT07060807 study?

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

What treatments are being tested in NCT07060807?

The interventions being studied include: Patritumab deruxtecan (BIOLOGICAL), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Capecitabine (DRUG), Liposomal doxorubicin (DRUG). Administered via intravenous (IV) infusion

What does Phase 3 mean for NCT07060807?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT07060807?

This trial is currently "Recruiting." It started on 2025-07-21. The estimated completion date is 2033-07-14.

Who is sponsoring NCT07060807?

NCT07060807 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07060807?

The trial aims to enroll 1000 participants. The trial is currently recruiting and accepting new participants.

How is NCT07060807 designed?

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

What are the primary outcomes being measured in NCT07060807?

The primary outcome measures are: Progression Free Survival (PFS) (Up to approximately 45 months); Overall Survival (OS) (Up to approximately 85 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07060807 being conducted?

This trial is being conducted at 20 sites, including Daphne, Alabama; Tucson, Arizona; Los Angeles, California; Newport Beach, California and 16 more sites (United States).

Where can I find official information about NCT07060807?

The official record for NCT07060807 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07060807. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07060807 testing in simple terms?

This study tests a new drug called patritumab deruxtecan against standard treatments for advanced hormone-receptor-positive, HER2-negative breast cancer. It is for patients whose cancer has spread or cannot be removed by surgery and has not responded to previous treatments, including hormone therapy and CDK4/6 inhibitors.

Why is this trial significant?

This trial addresses a critical need for new treatments in advanced HR+/HER2- breast cancer that has become resistant to existing therapies, potentially offering a new option for patients with limited As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT07060807?

Common side effects may include low blood cell counts, nausea, vomiting, diarrhea, and fatigue. There is a risk of lung problems (pneumonitis) and eye problems, which require prompt medical attention. Skin reactions, mouth sores, and hair loss can also occur. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07060807?

Ask your doctor if your cancer is HR+/HER2- and if you have progressed on CDK4/6 inhibitor plus endocrine therapy. Understand that you will be randomly assigned to one of two treatment groups, and you may not know which one you are receiving. Be prepared for regular clinic visits for treatment, monitoring, and potential side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07060807 signal from an investment perspective?

This trial targets a large market of patients with advanced breast cancer, aiming to establish patritumab deruxtecan as a new standard of care, which could lead to significant commercial success if ap This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

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

Participants will be randomly assigned to receive either patritumab deruxtecan or the treatment their doctor chooses, which could be chemotherapy or another drug. 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.