CER San Juan | San Juan, Argentina
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About
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.
Enrollment
Sex
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Volunteers
Inclusion criteria
Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
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.
Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence:
The participant must be randomized within 16 months from the time of definitive breast cancer surgery.
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.
Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
The participant has adequate organ function.
The participant is able to swallow oral medications.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
5,637 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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