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
25 octobre 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 | 24/09/2026 13:15:04 | 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 time of diagnosis of locally
advanced unresectable or metastatic breast cancer. A new biopsy obtained after
progression of the most recent line of therapy is preferred
- 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) interstitial lung disease (ILD) or pneumonitis
irrespective of steroid use, or has current ILD or suspected ILD, or ILD 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