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Study record managers: refer to the Data Element Definitions if submitting registration or information. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning up to noon.

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Study record managers: refer to the Data Element Definitions if submitting registration or information. Endocrine therapy physicians' choice standard-of-care was administered according to package label until discontinuation criteria were met. Drug: Abemaciclib Administered orally.

Endocrine Therapy Endocrine therapy physicians' choice standard-of-care was administered according to package label until discontinuation criteria were met. Talk with your doctor and family members or friends about deciding to a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

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For general information, Learn About Clinical Studies. Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms.

Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. First Posted : April 9, Last Update Posted : April 9, Study Description. MedlinePlus related topics: Breast Cancer. Drug Information available for: Abemaciclib.

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FDA Resources. Arms and Interventions. Outcome Measures. Primary Outcome Measures : Invasive Disease Free Survival IDFS [ Time Frame: Baseline to Recurrence or Death from Any Cause Up to 32 Months ] IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.

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Distant relapse-free survival is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first. Outcome data will be provided after the study is completed. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. The participant must have undergone definitive surgery of the primary breast tumor.

The participant must have tumor tissue from breast preferred or lymph node for exploratory biomarker analysis available prior to randomization. The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy surgery, chemotherapy, or radiation whichever is last. Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.

The participant has adequate organ function. The participant is able to swallow oral medications. Exclusion Criteria: Metastatic disease including contralateral axillary lymph nodes or node-negative disease. Participants with inflammatory breast cancer. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible.

Participants with a history of any other cancer except non-melanoma skin cancer or carcinoma in situ of the cervixunless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded. Females who are pregnant or lactating. The participant is receiving concurrent exogenous reproductive hormone therapy for example, birth control pills, hormone replacement therapy, or megestrol acetate.

The participant has ly received endocrine therapy for breast cancer prevention tamoxifen or aromatase inhibitors or raloxifene. The participant has serious preexisting medical condition s that, in the judgment of the investigator, would preclude participation in this study. The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism VTE. The participant has active systemic infections or viral load.

The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using poltava contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. Anargyroi N. PCK Sp. Jasnorzewska S. Radiology Therapeutic Center S. Agen of Health St. Petersburg, Russian Federation, St-Petersburg scientifical practical cente spec medical dating St. More Information. J Clin Oncol. Epub Sep National Library of Medicine U. National Institutes of Health U. Department of Health and Cary Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Breast Cancer. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :.

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Actual Primary Completion Date :. Estimated Study Completion Date :.

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Los Angeles, California, United States, California Cancer Associates in Research and Excellence. Lebanon, New Hampshire, United States, Hendersonville, North Carolina, United States, Philadelphia, Pennsylvania, United States, Greenville, South Carolina, United States, Spartanburg, South Carolina, United States, Texas Oncology-Baylor Charles A. Sammons Cancer Center. Hematology Oncology Associates of Fredericksburg Inc. Centros de Investigaciones Cli-nicas. Clinica Viedma. Centro Polivalente de Asistencia e Inv. Centro para la Atencion Integral del Paciente Oncologico.

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