A Phase II Study of Ribociclib And Endocrine Treatment of Physician s Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Locoregional Recurrent, Resected Hormone Receptor Positive Her2 Negative Breast Cancer
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Age: Between 18 Year(s) - 100 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
(1) Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. (2) ECOG Performance Status of 0-1 within 28 days prior to registration. (3) If patient is receiving tamoxifen or toremifene, a washout period of 28 days prior to registration is required. (4) Patients must enroll within 6 months of the last local treatment, surgery or radiation, whichever occurred last.
You may not be eligible for this study if the following are true:
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(1) Patient with a known hypersensitivity to any of the excipients of ribociclib. (2) Patient who has received prior CDK4/6 inhibitor for recurrent disease. (3) Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects. (4) Pregnant or breastfeeding or planning to become pregnant during the trial. (5) Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.