Asciminib in HER2+ Breast Cancer Brain Metastases
A Single Arm, Open-label Phase Ib/II Study of Asciminib in HER2+ Breast Cancer Brain Metastases (ASCENdANT)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests asciminib with trastuzumab to see how well they shrink cancer in the brain. It is for adults with HER2-positive breast cancer that has spread to the brain and has new or growing brain tumors. HER2-positive means the cancer has extra HER2 protein.
The purpose of this study is to evaluate the intracranial response rate of a combination of asciminib/trastuzumab for the treatment of patients with metastatic HER2+ breast cancer with brain metastases.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, with at least one new or growing brain tumor larger than 5 mm. Cancer outside the brain is not required.
- Have had at least one standard treatment for breast cancer that has spread. You must have had T-DXd and tucatinib, unless allergies or side effects kept you from taking them.
- Wait the required time after surgery, radiation, or cancer medicines before joining. Hormone therapy must stop before study treatment; treatment to stop the ovaries from making hormones may continue with your doctor's approval.
- Have blood counts and liver and kidney tests that meet study limits. Your heart must pump out at least 50% of the blood in its main pumping chamber with each beat.
- Be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
- If you can become pregnant, have a negative pregnancy test. Participants must agree to highly effective birth control or avoid sex that could cause pregnancy.
- A small area of cancer in the tissue covering the brain or spinal cord may be allowed if the study doctor agrees.
- Sign forms agreeing to join the study and allowing use of your health information.
Who can't join
- Brain bleeding, dangerous brain pressure, a need for urgent brain treatment, or a need for increasing steroid doses. You also cannot need more than 2 mg of dexamethasone daily, or a similar steroid dose, for brain symptoms.
- Widespread cancer in the tissue covering the brain or spinal cord, cancer cells in spinal fluid, poorly controlled seizures, or inability to have a brain MRI scan.
- Moderate or worse nerve damage, such as numbness or tingling in the hands or feet.
- Certain heart rhythm problems, heart failure, uncontrolled high blood pressure, serious heart or lung disease, or inflammation of the pancreas within the past 6 months.
- A serious active infection needing treatment, including treatment through a vein. Some people with past or controlled hepatitis B, hepatitis C, or HIV may still qualify.
- Recent use of certain medicines that interact with study treatment, inability to avoid those medicines, or use of an experimental drug within 30 days before enrollment.
- Being pregnant or breastfeeding. Breast milk cannot be saved during study treatment for later use.
- Another cancer within the past 5 years that the doctor thinks could affect study safety or the ability to judge treatment results.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Age ≥18 years at the time of consent * Patients with HER2+ metastatic breast cancer with at least one progressive or new brain metastasis measuring \>5mm; prior local therapy to other intracranial lesions allowed * At least 1 prior standard of care therapy for metastatic disease * Must have previously received T-DXd and Tucatinib. If a patient has not received T-DXd or Tucatinib as part of standard early line therapy due to allergies or intolerability, the requirement of prior T-DXd and Tucatinib treatment is waived. * Participants must have adequate treatment washout period when applicable before enrollment, defined as: * \>4 weeks from any major surgery * \>1 week from any cranial radiation treatment * For cytotoxic containing agents, 5 half-lives or at least 21 days (whichever is shorter) * For weekly chemotherapy regimens, \>2 weeks from chemotherapy; for every 3 weekly regimens, \>3 weeks from chemotherapy. At least 2 weeks from other systemic or targeted or investigational therapies (other than endocrine therapy) for breast cancer. No washout is required for endocrine therapy (e.g. aromatase inhibitors, tamoxifen, fulvestrant) but patients should discontinue prior to start of protocol therapy. * Patients on ovarian suppression are allowed (but not required) to continue ovarian suppression at the discretion of their treating provider. * Adequate organ function and bone marrow reserve as determined by the investigator * Adequate hepatic and renal function and hematologic parameters: * Absolute neutrophil count (ANC) ≥ 1.0 × 109/L * Platelets ≥ 100 × 109/L * Hemoglobin ≥ 9 g/dL * Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present) * Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as calculated using the Cockcroft-Gault (CG) equation * Left ventricular ejection fraction (LVEF) ≥ 50%. * Females of childbearing potential must have a negative pregnancy test (serum or urine) at screening. If a pregnancy test using either method is positive or cannot be confirmed as negative, a second testing using the other method will be required for confirmation. * Females of childbearing potential and males must be willing to abstain from heterosexual intercourse or to use highly effective contraception * Can enroll with intracranial disease only; extracranial disease can be absent or non-measurable * Focal leptomeningeal disease allowed at investigator discretion * Performance status by Eastern Cooperative Oncology Group (ECOG) 0-2 (appendix 1) * Written informed consent and HIPAA authorization for release of personal health information prior to enrollment. NOTE: HIPAA authorization may be included in the informed consent or obtained separately Exclusion Criteria: * No evidence of hemorrhage or impending herniation or need for immediate local therapy to intracranial disease or escalating dosing of steroids * No grade 2 or greater peripheral neuropathy * Diffuse and symptomatic leptomeningeal carcinomatosis * Prolonged Qtc (QTcF\>450), CHF or uncontrolled HTN * Clinically significant cardiopulmonary disease. * Acute or chronic pancreatitis within 6 months prior to first day of study treatment * Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including: * tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice), * hepatitis B (known positive HBV surface antigen (HBsAg) result) , * hepatitis C (note: hepatitis C testing at screening will only be performed on those at high risk or with known history), or * human immunodeficiency virus (positive HIV 1/2 antibodies) (note: HIV testing at screening will only be performed on those at high risk or with known history) * NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed if they are stable and have been on treatment for ≥ 4 weeks prior to first dose of study drug(s). Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy. Testing not required. * Unable for any reason to undergo MRI of the brain. * Use of a strong cytochrome P450 (CYP)3A4 inhibitor within 5 half-lives of study treatment. .. Unable to avoid certain CYP3A4 or CYP2C9 substrates which cannot be co-administered with study treatment given altered substrate concentrations. * Central nervous system exclusion - Based on screening brain MRI, patients must not have any of the following: * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \> 2 mg of dexamethasone (or equivalent) * Diffuse leptomeningeal disease or positive CSF cytology; however, discreet dural-based metastases are allowed * Poorly controlled seizures. Defined as seizures that continue to occur despite optimal anticonvulsant medications based on investigator discretion. * Active infection requiring intravenous systemic therapy. * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). * Patients with a prior or concurrent malignancy within last 5 years whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial. * Treatment with any investigational drug within 30 days prior to enrollment (Day 1 of study drug).
Study sites (1)
NC
- Duke University · Durham, NC 27710Carey Anders, MD · Study contact · 919-471-8344 · carey.anders@duke.eduBreast Clinic · Study contact · 919-660-1278 · breastcl@dm.duke.eduMore trials in Durham