A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
ConditionBreast Neoplasms
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
Qualifiers
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)
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Patritumab deruxtecan
- Paclitaxel
- Nab-paclitaxel
- Capecitabine
- Liposomal doxorubicin
- Trastuzumab deruxtecan
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
Daiichi Sankyo
Collaborator
Source ClinicalTrials.gov