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New treatment option for Breast Neoplasms
Official title Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
ClinicalTrials.gov ID: NCT06686394
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 want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body).
- Phase 2: a mid-size study of how well it works
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 histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer
- Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and...
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
You likely can't join if
- The main exclusion criteria include but are not limited to the following:
- Uncontrolled or significant cardiovascular disease
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease
- Has clinically severe respiratory compromise
- Has any history of or evidence of any current leptomeningeal disease
- Has clinically significant corneal disease
See the full eligibility criteria
- The main include but are not limited to the following:
- Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer
- Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention Arm 1:
- Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting
- Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment Arm 2: -Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting Arm 3: -Has...
- The main exclusion criteria include but are not limited to the following:
- Uncontrolled or significant cardiovascular disease
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease
- Has clinically severe respiratory compromise
- Has any history of or evidence of any current leptomeningeal disease
- Has clinically significant corneal disease
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
- HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Evidence of spinal cord compression or brain metastases
- Has an active infection requiring systemic therapy
- Concurrent active HBV and HCV infection
- Has had major surgical procedure (excluding placement of vascular access) less than 28 days Arm 3 ONLY \- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted...
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
- New Brunswick, New Jersey, United States
- Greenville, South Carolina, United States
- Fairfax, Virginia, United States
- Kingston, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Haifa, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- Nagoya, Aichi-ken, Japan
- Seoul, South Korea
- London, Camden, United Kingdom
- Glasgow, Glasgow City, United Kingdom
- London, London, City of, United Kingdom
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 Aurora, Colorado, United States; Boston, Massachusetts, United States; New Brunswick, New Jersey, United States; Greenville, South Carolina, United States; Fairfax, Virginia, United States; Kingston, Ontario, Canada and 10 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.