A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

NCT06678269 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 24-138
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Metastatic Breast Cancer; Stage IV Breast Cancer; Breast Cancer; Breast Cancer Stage IV; Breast Cancer Metastatic; HER2-negative Breast Cancer; HER2 Negative Breast Carcinoma; Hormone-receptor-positive Breast Cancer

Keywords

Metastatic Breast Cancer; Stage IV Breast Cancer; Breast Cancer; Breast Cancer Stage IV; Breast Cancer Metastatic; HER2-negative Breast Cancer; HER2 Negative Breast Carcinoma; Hormone-receptor-positive Breast Cancer; Memorial Sloan Kettering Cancer Center; 24-138

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose/MTD of abemaciclib

  The primary endpoint of the study is defining the MTD of abemaciclib in combination with Radiation Therapy/RT

  up to 1 year

Study Arms (1)

Participants with HR+, HER2- metastatic breast cancer

EXPERIMENTAL

Participants will have a diagnosis of HR+, HER2- metastatic breast cancer. Abemaciclib, orally every 12 (± 2) hours beginning on the day of simulation thru the final day of radiotherapy for a maximum 28-day course. Radiation therapy, 27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation.

Drug: Abemaciclib; Radiation: Radiation Therapy

Interventions

Abemaciclib DRUG

The dose escalation portion of the study, a 3+3 design will be used. Once the MTD of Abemaciclib is reached, the phase Ib expansion portion will enroll up to 10 additional patients also requiring palliation to bone metastases

Participants with HR+, HER2- metastatic breast cancer

Radiation Therapy RADIATION

27Gy in 3 daily fractions or 30Gy in 5 daily fractions completed entirely within 28 days of simulation via stereotactic body radiotherapy (SBRT).

Participants with HR+, HER2- metastatic breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Bone lesions in the calvarium are not eligible for the dose-finding or expansion portions of the study.
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: collaborator
• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lior Braunstein, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Braunstein, MD

CONTACT

201-775-7446; braunstl@mskcc.org

Rui Wang, MD, PhD

CONTACT

201-775-7445; wangr5@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (7)