Breast Cancer Clinical Trial

Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases

Summary

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.

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Full Description

The study is designed as a prospective, single-arm, nonrandomized, open-label, phase I/II trial of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases. Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation to sites of brain metastases or post-operative cavities with continued abemaciclib. Safety will be monitored initially by a 3+3 design. This will be followed by a phase 2 study to evaluate intracranial progression free survival (PFS). If unexpected neurologic toxicities are noted, the dose of radiation therapy will be modified.

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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> 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
Patients with prior history of nonbreast cancer malignancies should have no evidence of disease ≥ 2 years
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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT04923542

Recruitment Status:

Recruiting

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There is 1 Location for this study

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Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Michelle DeJesus
Contact
813-745-6911
[email protected]
Avan Armaghani, MD
Sub-Investigator
John Arrington, MD
Sub-Investigator
Ricardo Costa, MD, MSc
Sub-Investigator
Arnold Etame, MD, PhD
Sub-Investigator
Peter Forsyth, MD
Sub-Investigator
Hung Khong, MD
Sub-Investigator
James Liu, MD
Sub-Investigator
Daniel Oliver, MD
Sub-Investigator
Marilin Rosa, MD
Sub-Investigator
Hatem Soliman, MD
Sub-Investigator
Aixa Soyano Muller, MD
Sub-Investigator
Nam Tran, MD, PhD
Sub-Investigator
Michael Vogelbaum, MD, PhD
Sub-Investigator
Michael Yu, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT04923542

Recruitment Status:

Recruiting

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

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