Actively Recruiting
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-12
60
Participants Needed
7
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential treatments (given one after another)-combined with local therapies (which treat cancer in a specific part of the body) and treatments that prevent cancer from spreading to the central nervous system (CNS; including the brain and spinal cord) can result in long-lasting remission and possibly cure some participants with HER2+ metastatic breast cancer.
CONDITIONS
Official Title
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with unresectable locally advanced or metastatic breast cancer (stage IV at diagnosis)
- HER2 IHC test results of 3+
- Life expectancy of at least 12 weeks
- Medically fit for surgery or potentially operable if responding to induction therapy
- Measurable disease according to PERCIST 1.0 criteria
- Provide written informed consent
- ECOG performance status of 0 to 1
- Adequate organ function based on defined laboratory values within 14 days prior to study start
- Female participants must not be pregnant or breastfeeding and must meet specific contraception requirements during the study
- Male participants must agree to use contraception or remain abstinent during and for 7 days after therapy
- Participants with controlled Hepatitis B or C infection meeting specific criteria
You will not qualify if you...
- HER2 IHC results of 1-2+ with positive FISH or ISH instead of 3+
- Prior anti-HER2 or systemic anti-cancer treatment for breast cancer
- Participation in another investigational study or use of investigational device within 2 weeks before study
- Immunodeficiency or recent systemic steroid or immunosuppressive therapy
- Active additional malignancy requiring treatment within past 3 years (except certain skin or bladder cancers)
- Known central nervous system metastases or leptomeningeal carcinomatosis
- History or current active pneumonitis or interstitial lung disease requiring steroids
- Grade 3 or higher neuropathy
- Active infection requiring antibiotics
- Known HIV infection
- Inability to swallow capsules or tablets
- Conditions or disorders interfering with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or expecting to conceive during study
- History of allogenic tissue or solid organ transplant
- Significant cardiovascular issues within 12 months prior to study
- Left ventricular ejection fraction below institutional normal range
- Intolerance to study drugs or excipients
- Major surgery within 3 weeks prior to first dose without adequate wound healing
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
P
Pedram Razavi, MD, PhD
CONTACT
A
Atif Khan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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