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1 Study Matches

A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE).

This is a drug study that will examine the drug Ribociclib with endocrine therapy versus just endocrine therapy in patients with early breast cancer.
Kathleen Rizzo at
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization
Patient has breast cancer that is positive for ER and/or PgR
Patient has HER2-negative breast cancer defined as a negative
Patient has available archival tumor tissue from the surgical specimen, for submission to a central laboratory.
If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
Exclusion Criteria:
Patient has received any CDK4/6 inhibitor
Patient has received prior treatment with tamoxifen, raloxifene or AIs
Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
h a known hypersensitivity to any of the excipients of ribociclib and/or ET (
Patient with distant metastases of breast cancer beyond regional lymph nodes
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Hershey, PA