Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04049227|
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Endometrioid Adenocarcinoma||Drug: Abemaciclib Drug: Letrozole Procedure: Therapeutic Conventional Surgery||Early Phase 1|
I. To determine whether there are changes in Ki-67 expression from the pretreatment specimen (e.g. biopsy or dilation and curettage [D&C]) to the post-treatment hysterectomy specimen following treatment with letrozole and abemaciclib.
I. To determine the proportion of tumors with complete cell cycle arrest (CCCA) response as measured by Ki-67 expression between the pre-treatment tumor and the posttreatment tumor.
II. To identify biological characteristics of tumors (e.g. mismatch repair [MMR] status, PTEN mutational status, etc.) correlating with decreased Ki-67 expression induced by the letrozole and abemaciclib combination.
III. To determine the frequency of adverse events associated with use of abemaciclib and letrozole.
I. To evaluate the correlation of the expression of Ki-67 with that of cyclin D1, p16, pRB, and PTEN as well as with MMR deficiency.
Patients receive letrozole orally (PO) once daily (QD) and abemaciclib PO twice daily (BID) on days 1-14. Patients then undergo standard of care hysterectomy on day 15.
After completion of study treatment, patients are followed up at 30 days and at 2 and 6 weeks after surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot, Multicenter, Single Arm, Open Label, Surgical Window of Opportunity Study of Abemaciclib and Letrozole for Endometrioid Adenocarcinoma of the Endometrium|
|Actual Study Start Date :||August 12, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2023|
Experimental: Treatment (letrozole, abemaciclib)
Patients receive letrozole PO QD and abemaciclib PO BID on days 1-14. Patients then undergo standard of care hysterectomy on day 15.
Procedure: Therapeutic Conventional Surgery
Undergo standard of care hysterectomy
- Changes in Ki-67 expression [ Time Frame: Baseline up to 6 weeks ]
- Proportion of tumors with complete cell cycle arrest (CCCA) response [ Time Frame: At day 15 ]
Will be measured by Ki-67 between the pre-treatment tumor and the post-treatment tumor. CCCA response is defined as less than 3% of tumor cells staining positive for Ki-67 from specimens obtained at time of hysterectomy. Baseline biomarker levels will be compared between patients who do vs.
do not achieve complete CCCA using a two-sample t-test.
- Biological characteristics of tumors: MMR status [ Time Frame: Up to 6 weeks ]Will be measured to correlate with decreased Ki-67 expression induced by the letrozole and abemaciclib combination.
- Biological characteristics of tumors: PTEN mutational status [ Time Frame: Up to 6 weeks ]Will be measured to correlate with decreased Ki-67 expression induced by the letrozole and abemaciclib combination.
- Biological characteristics of tumors: expression of cyclin D1 [ Time Frame: Up to 6 weeks ]Will be measured to correlate with decreased Ki-67 expression induced by the letrozole and abemaciclib combination.
- Biological characteristics of tumors: p16 [ Time Frame: Up to 6 weeks ]
- Biological characteristics of tumors: pRB [ Time Frame: Up to 6 weeks ]
- Incidence of adverse events associated with abemaciclib and letrozole [ Time Frame: Up to 6 weeks ]Categorized and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049227
|Contact: Study Coordinator||(312)email@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Emma Barber, MD, MS 312-472-4684|
|Principal Investigator: Emma Barber, MD, MS|
|University of Chicago Comprehensive Cancer Center||Not yet recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: John W. Moroney 773-702-6118 firstname.lastname@example.org|
|Principal Investigator: John W. Moroney|
|Principal Investigator:||Emma Barber, MD, MS||Northwestern University|