A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer
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 different doses of abemaciclib to find the best dose to use with hormone therapy and radiation. It is for adults with hormone-sensitive, HER2-negative breast cancer that has spread, who need radiation to cancer in a bone.
The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.
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. Men and women may join.
- Have stage IV breast cancer confirmed by a tissue test. The cancer must have estrogen or progesterone receptors and test negative for HER2, a protein that helps cancer grow.
- Plan to get focused, high-dose radiation called SBRT to cancer in a bone, including the spine. Your doctor must plan to restart abemaciclib after radiation.
- Any past cancer treatment is allowed, but required breaks and recovery rules apply. These include at least 21 days after chemotherapy, 14 days after radiation, and 7 days after palbociclib or ribociclib.
- Be able to swallow pills and have blood cell counts and liver test results that meet study limits.
- Be well enough to care for yourself at least partly, as measured by the study's activity scales.
- Have a negative pregnancy test if required. Women who can become pregnant must use approved birth control through 28 days after the last study dose. Men must use barrier birth control during treatment and for 4 weeks afterward.
- You or your legal representative must give written consent, and you must follow study procedures.
Who can't join
- Need study radiation to cancer in the skull bones. Skull bone cancer not being treated in this study does not rule you out.
- Have already had radiation to the planned treatment site, or have had radiation within 14 days before starting the study drugs.
- Are in another study that conflicts with this one, or recently received an experimental treatment. The required wait is at least 30 days or longer, depending on how long the treatment stays in the body.
- Have a serious or uncontrolled illness that makes joining unsafe, such as severe lung or kidney disease, major stomach or small bowel surgery, or ongoing bowel disease with significant diarrhea.
- Are pregnant or breastfeeding.
- Have an active bacterial infection needing IV antibiotics, a fungal infection, or a detectable viral infection such as HIV or active hepatitis B or C.
- Have a history of fainting caused by a heart problem, certain dangerous heart rhythms, or sudden cardiac arrest, when the heart stops beating.
- Have cancer pressing on the spinal cord at the severity level ruled out by the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Aged ≥18 years at signing of informed consent. * Both male and female patients are allowed * Histologically confirmed metastatic breast cancer (mBC), current stage IV. * Plan for ablative radiotherapy (SBRT) to a bone metastasis. * Documented estrogen receptor (ER) positive and/or progesterone receptor (PgR) positive by immunohistochemistry. The threshold to qualify as ER or PgR positive is ≥1% per ASCO/CAP guidelines. * HER2 negative tumor status confirmed by immunohistochemistry or FISH per ASCO/CAP guidelines. * Any line of prior treatments (hormonal therapy and chemotherapy) is permitted including prior abemaciclib, palbociclib and ribociclib. * At the time of enrollment, treating physician has intent to resume abemaciclib (at any dose) following radiotherapy. * Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy). * Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment. No prior radiotherapy to the current intended target site is permitted (ie. reirradiation is excluded from this study). * The patient must be able to swallow oral medications. * The patient must have adequate organ function per the following criteria (as defined in Table 2): Table 2: Laboratory Value Guidance to Establish Adequate Organ Function Hematologic ANC: ≥1.5 x 10\^9/L Platelets: ≥100 x 10\^9/L Hemoglobin: ≥8 g/dL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion. Hepatic Total bilirubin: ≤1.5 x ULN Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted ALT and AST: ≤3 x ULN * Patient may remain on hormonal therapy and abemaciclib before enrollment. * Patients must discontinue other CDK4/6 inhibitor (palbociclib or ribociclib) for at least 7 days and recover from the acute effects of therapy (until the toxicity resolves to ≤Grade 1) except for residual alopecia and peripheral neuropathy. * Measurable or non-measurable disease is permitted as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). * Patients must have an Eastern Cooperative Oncology Group (ECOG) status of ≤2 or Karnofsky Performance Status (KPS) ≥60. * Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause. * Women of childbearing potential must agree and commit to the use of a highly effective method of contraception as determined to be acceptable by the investigator, from the time of informed consent until 28 days after the last dose of the investigational product. Men must agree and commit to use a barrier method of contraception while on treatment and for 4 weeks after last dose of investigational products. * Patients (or their legally authorized representative) must provide written, informed consent to participate in the study and follow the study procedures * At the discretion of the treating radiation oncologist, radiation to a metastatic bone lesion is indicated inclusive of bone lesions in the spinal column. Exclusion Criteria: * Treatment to bone lesions in the calvarium are not eligible for the dose-finding or expansion portions of the study. Patients who otherwise have calvarial lesions not undergoing treatment on this protocol are eligible to enroll. * Patients currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to the start of study intervention, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study. * Patients who received radiation therapy ≤14 days prior to initiation of investigational agents are excluded. * Patients are ineligible if they have 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). * Females who are pregnant or lactating. * 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. * Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 diarrhea of any etiology screening). * Malignant spinal cord compression (ESCC2 or above) * Prior radiation therapy to the current target site.
Study sites (7)
NJ
- Memorial Sloan Kettering at Basking Ridge (All protocol activities) · Basking Ridge, NJ 07920Lior Braunstein, MD · Study contact · 201-775-7446More trials in Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) · Middletown, NJ 07748Lior Braunstein, MD · Study contact · 201-775-7446More trials in Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) · Montvale, NJ 07645Lior Braunstein, MD · Study contact · 201-775-7446More trials in Montvale
NY
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities ) · Commack, NY 11725Lior Braunstein, MD · Study contact · 201-775-7446More trials in Commack
- Memorial Sloan Kettering Westchester (All Protocol Activities) · Harrison, NY 10604Lior Braunstein, MD · Study contact · 201-775-7446More trials in Harrison
- Memorial Sloan Kettering Cancer Center (All protocol activites) · New York, NY 10065Lior Braunstein, MD · Study contact · 201-775-7446More trials in New York
- Memorial Sloan Kettering Nassau (All protocol activities) · Rockville Centre, NY 11553Lior Braunstein, MD · Study contact · 201-775-7446More trials in Rockville Centre