RecruitingPhase 2

Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.

A Phase IIA Trial Assessing the Tolerability of Abemaciclib in Combination With Endocrine Therapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer Who Have Progressed on or After Prior CDK 4/6 Inhibition

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
70 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

  • Time periods mentioned: 2 years
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To describe the results of Was It Worth It (WIWI) and Overall Treatment Utility (OTU) questionnaires."
  • "After completion of study treatment, patients are followed up at 30 days, then every 6 months for 2 years."
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 the side effects of abemaciclib used alone. It is for people age 70 and older whose breast cancer uses hormones to grow, is HER2-negative, and has spread to other parts of the body. HER2 is a protein that can help cancer grow.

This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.

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 70 or older and expected to live more than 6 months.
  • Give written consent and be able to read and understand English or Spanish.
  • Have tests showing hormone receptor-positive, HER2-negative breast cancer, with scans showing it has spread.
  • Have cancer that got worse after hormone treatment, palbociclib, ribociclib, or chemotherapy.
  • After chemotherapy, wait at least 21 days and recover from most side effects. After radiation, wait at least 14 days and fully recover from its short-term effects.
  • Have no cancer in the brain or spinal cord, unless it meets special rules. Treated brain cancer must be stable, with treatment finished at least 4 weeks earlier and no steroids or certain seizure medicines for it.
  • Have no interstitial lung disease or pneumonitis, which cause lung damage or swelling.
  • Meet the study's blood cell count, liver test, and kidney function limits.

Who can't join

  • Had major surgery within 14 days before starting the study drug, or have not recovered from major side effects.
  • Take medicines or herbal products that are not allowed and cannot stop them 7 days before treatment, or have an allergy to ingredients in abemaciclib.
  • Have an active bacterial infection needing antibiotics through a vein, a fungal infection, or a detectable viral infection, such as HIV or active hepatitis B or C.
  • Cannot swallow pills, or have stomach or bowel problems that could keep the body from taking in the drug.
  • Have a history of heart-related fainting, certain dangerous heart rhythms, or sudden cardiac arrest.
  • Have another serious or uncontrolled illness that makes the study unsafe or hard to follow. Examples include severe breathing or kidney problems and ongoing diarrhea.
  • Have a history of not following medical treatment instructions.
  • Had another cancer diagnosed within the past 2 years that is still present. Some treated skin cancers and cervical cancer removed by surgery are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Documented informed consent of the participant * Age \>= 70 years * Life expectancy \> 6 months * Ability to read and understand English or Spanish * Measurable or non-measurable disease * Histologically or cytologically confirmed diagnosis of: * Estrogen-receptor positive and/or progesterone receptor positive breast cancer determined by immunohistochemistry (IHC) methods according to the local institution standard protocol * HER2-negative breast cancer defined as negative if the IHC status is 0 or 1+, or if IHC is 2+ and in situ hybridization assay is negative per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines * Radiographically confirmed metastatic breast cancer * Progressed on prior endocrine therapy or palbociclib or ribociclib or chemotherapy * Patients who received chemotherapy recovered from the acute side effects to prior cancer therapy (except alopecia or residual grade 2 peripheral neuropathy) to =\< grade 1 or baseline. A washout period of at least 21 days is required between last chemotherapy dose and randomization (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 randomization * Absence of central nervous system (CNS) involvement unless they meet ONE of the following criteria: * Untreated brain metastases (e.g., lesions \< 1 cm) not needing immediate local therapy * Previously treated brain metastases not needing immediate local therapy * At least 4 weeks from the last date of prior therapy completion (including radiation and/or surgery) to starting the study treatment * Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases * Absence of interstitial lung disease/pneumonitis * Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L * Platelets \>= 100 x 10\^9/L * Hemoglobin \>= 8 g/dL * (Patients 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) * In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3.0 x upper limit of normal (ULN) * If the patient has liver metastases, ALT and AST \< 5 x ULN * In patients without Gilbert's syndrome, total bilirubin =\< 1.5 x ULN; In patients with Gilbert's syndrome, total bilirubin =\< 2.0 x ULN or direct bilirubin within normal limits (WLN) * Creatinine clearance of \>= 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula Exclusion Criteria: * Major surgery within 14 days prior to receiving study drug or has not recovered from major side effect * Patient is currently receiving any of the prohibited medications detailed below and cannot be discontinued 7 days prior to starting study drug * Other investigational therapy should be given to participants * Anticancer agents other than the study medications administered as part of this study protocol should be given to participants. If such agents are required for a participant then the participant must first be withdrawn from the study * Co-medication that may interfere with study results; e.g. immune-suppressive agents other than corticosteroids, such as systemic cyclosporine and tacrolimus are prohibited during the treatment phase of the study, unless discussed with principal investigator felt to be of low clinical risk to the participant * Use of herbal medications may have unknown interactions with the metabolism of the study agents, and therefore are prohibited from use during the treatment phase of the trial * Known hypersensitivity to any of the excipients of abemaciclib * 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 * Impairment of gastrointestinal (GI) function or GI disease that in the investigator's opinion may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) * 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 * Patient has any other concurrent severe or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis) * Inability to swallow oral medications * Serious 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 \[e.g. estimated creatinine clearance \< 30 ml/min\], 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) * History of non-compliance to medical regimen * Patients with a prior malignancy diagnosed within 2 years and with evidence of disease (except adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer

Study sites (6)

CA

MA

NY