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New treatment option for Breast Neoplasms
Official title A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
ClinicalTrials.gov ID: NCT07060807
What this study is testing
What is Patritumab deruxtecan?
Patritumab deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast neoplasms.
Also referred to as MK-1022, HER3-DXd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main 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...
- Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a...
- 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...
You likely can't join if
- 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)...
- 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...
- Has any of the following: a pulse oximeter reading \<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental...
See the full eligibility criteria
- The main 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...
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Daphne, Alabama, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Grand Junction, Colorado, United States
- Newark, Delaware, United States
- Altamonte Springs, Florida, United States
- St. Petersburg, Florida, United States
- Lexington, Kentucky, United States
- Hackensack, New Jersey, United States
- New Brunswick, New Jersey, United States
- Albuquerque, New Mexico, United States
- Rio Rancho, New Mexico, United States
- Jamaica, New York, United States
- Westbury, New York, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- York, Pennsylvania, United States
+ 143 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daphne, Alabama, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Newport Beach, California, United States; Grand Junction, Colorado, United States; Newark, Delaware, United States and 157 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.