SRS & Abemaciclib w/wo Imlunestrant in the Management of HR+/HER2- Breast CA Brain Metastases
Phase I/II Study of Stereotactic Radiation and Abemaciclib With or Without Imlunestrant in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases (STRONG Trial)
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
- All sexes
- 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 abemaciclib and hormone therapy with stereotactic radiosurgery (SRS), a focused radiation treatment. It is for people whose breast cancer has spread to the brain and is HR-positive (uses hormones to grow) and HER2-negative (does not have high levels of the HER2 protein).
This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer 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
- Have HR-positive, HER2-negative breast cancer confirmed by tumor testing.
- Have 15 or fewer brain tumors that can be treated with focused radiation. The largest tumor must be 4 cm across or smaller.
- Have a brain tumor or space left after tumor surgery that measures at least 0.5 cm and is eligible for focused radiation.
- If you had focused brain radiation before, the active brain disease being measured must not have been treated with radiation.
- Be able to care for yourself and be up and about at least half of your waking hours. Your organs must work well enough under the study rules.
- Be able to swallow medicines, follow study steps, and take part for the full study.
- Provide a tumor sample for testing if available. You may still join if attempts to get stored tissue fail.
- If you could become pregnant, have a negative blood pregnancy test within 7 days before starting abemaciclib. Follow birth control instructions during treatment and for 3 weeks after the last abemaciclib dose.
Who can't join
- Have cancer in the lining around the brain or spinal cord, or have had radiation to the whole brain.
- Have taken abemaciclib while you had brain tumors, or within the past 6 months for cancer that has spread.
- Still have more than mild side effects from past cancer treatment, unless they meet the study's exceptions. Have an allergy to a study drug or its ingredients.
- Are pregnant or breastfeeding, or are a prisoner or being held against your will.
- Have a serious or uncontrolled illness that makes joining unsafe, certain active infections, or a history of heart-related fainting, certain dangerous heart rhythms, or sudden cardiac arrest.
- Had another cancer within the past 2 years, unless it has a very low risk of spreading or causing death or the lead study doctor allows it.
- Have not recovered from major surgery or a serious injury by 14 days before starting the study drug.
- Have taken part in a study of an experimental drug or device within 2 weeks before the first study treatment dose.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * HR+ breast cancer to fulfill the requirement of HR+ disease, a breast cancer must express (≥ 1%), by immunohistochemistry (IHC), at least 1 of the hormone receptors (estrogen receptor \[ER\] or progesterone receptor \[PR\]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines * To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines * ≤ 15 brain metastases eligible for stereotactic radiation * Able to swallow oral medications * Willing to comply with all study procedures and available for duration of the study * Measurable brain disease per RANO-BM criteria that can be measured in at least one dimension as ≥ 0.5 cm for both intact brain metastases and post-operative cavities * Eligible for SRS to brain metastases or to the post-operative bed following surgical resection * Maximum diameter of the largest intact brain metastases ≤ 4 cm * Eastern Cooperative Oncology Group performance status 0 to 2 * A formalin-fixed, paraffin-embedded tumor tissue block or 10 unstained slides of intracranial/extracranial tumor sample (archival or recent) for biomarker evaluation should be made available and submitted to the central lab for correlative studies. If attempts to obtain archival tissue are unsuccessful the patient may be enrolled. * Individuals with prior SRS/fractioned stereotactic radiotherapy (FSRT) treatment will be allowed if active measurable disease has not previously been treated with radiation therapy * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 7 days of the first dose of abemaciclib * WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s), and for three weeks following the last dose of abemaciclib * Adequate organ function as defined in protocol Exclusion Criteria: * Presence of leptomeningeal disease * Prior receipt of whole brain radiation therapy * Prior receipt of abemaciclib in the setting of brain metastases or in the past 6 months for the treatment of metastatic disease. * All toxicities attributed to prior anticancer therapy must have been resolved to Grade 1 (NCI CTCAE Version 5) or baseline before administration of study drug(s) other than: a. Toxicities attributed to prior anticancer therapy that either are not expected to resolve and/or result in long-lasting sequelae, such as neuropathy after platinum-based therapy b. Toxicities that are not expected to interfere with study treatment, such as fatigue, alopecia, or grade 2 hematologic toxicity * Women who are pregnant or breastfeeding * The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \<30ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea) * The patient has active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment * The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest * History of prior malignancy within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \>90%), such as but not limited to, non-melanoma skin carcinoma, or stage I endometriod uterine cancer, and others at the discretion of the PI. * Major surgery or significant traumatic injury that has not been recovered from by 14 days before the initiation of study drug * Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of first dose of study treatment * History of allergy or hypersensitivity to any of the study drugs or study drug components * Prisoners or individuals who are involuntarily incarcerated
Study sites (2)
FL
- Moffitt Cancer Center · Tampa, FL 33612More trials in Tampa
OH
- Ohio State University Comprehensive Cancer Center · Columbus, OH 43210Sasha Beyer, MD, PhD · Principal investigatorMore trials in Columbus