Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
juillet 2025
juillet 2033
17 juin 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 09/06/2026 08:05:34 | Contacter | ||
Critères
Tous
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