Abemaciclib With Letrozole in Recurrent or Persistent Endometrial Cancer

Principal Investigator: Panagiotis Konstantininopoulos, MD, Dana-Farber Cancer Institute, Boston, Massachusetts.

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Description: This phase 2, single-arm trial seeks to examine the role of a combination of targeted therapies — aromatase inhibitor (AI) letrozole and abemaciclib, a small-molecule inhibitor of cyclin-dependent kinase (CDK) inhibitor 4/6 (CDK4/6) — in advanced endometrial cancer.

Patients enrolled into the experimental arm of the trial will receive both of the medications by mouth twice daily.

Eligible participants are aged 18 years and older with ER-positive disease who have cytologically or histologically confirmed endometrial cancer that is recurrent or metastatic and/or is resistant to standard therapies.

Although there is no required washout period for hormonal therapy, participants will be excluded from enrollment if they have received chemotherapy, immune therapy, other investigational therapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study medication.

Some other exclusions include: participants who have had tyrosine kinase inhibitor (TKI) therapy within 5 half-lives of study entry, have had radiation therapy within 2 weeks of the first dose of study medication, have received previous treatment with CDK4/6 inhibitors, those with known brain metastases, and those with a history of atrial fibrillation or uncontrolled hypertension.

To read the full list of participant criteria please refer to the original study.

Status: This study is ongoing and recruiting patients as of September 18, 2018.

This study is sponsored by Dana-Farber Cancer Institute in collaboration with Eli Lilly and Company.


Clinicaltrials.gov. Abemaciclib With Letrozole in Recurrent or Persistent Endometrial Cancer. NCT03675893. https://clinicaltrials.gov/ct2/show/NCT03675893. Accessed October 26, 2020.