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Abemaciclib and Letrozole to Treat Endometrial Cancer

Primary Purpose

Endometrial Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abemaciclib
Letrozole
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient must have advanced (FIGO 2014 Stage III or IV), persistent, or recurrent endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy. Histologic confirmation of recurrent disease is required. For cases of persistent disease, histologic confirmation of the primary disease with radiologic evidence of progression is required.
  2. Patients must have endometrioid histology (all grades allowed) based on hysterectomy or biopsy specimen (Hormone receptor status is not required for enrollment).

    Sites are required to report results of previous MMR, MSI, and ER/PR status testing in Medidata Rave if available.

  3. All patients must have measurable disease. Measurable disease is defined by RECIST version 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15mm in short axis when measured by CT or MRI.

    Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.

  4. Prior chemotherapy in the adjuvant setting for Stage I, II, or III is permitted. Prior chemoradiotherapy for a pelvic recurrence is permitted.

    Note: Chemotherapy in the setting of Stage IV disease is permitted but the patient must be without evidence of disease at the completion of chemotherapy and have at least six months of progression-free survival since the completion of chemotherapy before detection of the recurrent cancer for which she is receiving treatment on this protocol.

    Prior immunotherapy and/or targeted therapy is allowed in addition to, in combination with, in lieu of, or subsequent to prior chemotherapy.

    Regardless of circumstances, no more than one prior chemotherapy regimen (including chemo-radiotherapy) is permitted, and no more than one additional systemic therapy is permitted. Hence, eligible patient may have received 0, 1, or 2 prior lines of systemic therapy and for women who received two prior lines of therapy, only one of them may have included chemotherapy.

    Patients who received prior chemotherapy, immunotherapy or targeted therapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last systemic therapy dose and initiation of therapy.

    Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and initiation of therapy.

  5. Patient must be able to swallow oral medications.
  6. Patient must have an ECOG performance status of 0 to 1.
  7. Patients must have adequate organ and marrow function as defined below NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN

    Bone marrow function:

    • Absolute neutrophil count (ANC) greater than or equal to 1500/mcl
    • Platelets greater than or equal to 100,000 cells/mcl
    • Hemoglobin greater than or equal to 8 g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after erythrocyte transfusion).

    Renal function:

    • Creatinine less than or equal to 1.5 x ULN

    Hepatic function:

    • Bilirubin less than or equal to 1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2 times ULN and direct bilirubin within normal limits are permitted).
    • ALT (alanine aminotransferase) and AST (aspartate aminotransferase) less than or equal to 3 x ULN
    • Alkaline phosphatase less than or equal to 2.5 x ULN
    • Albumin greater than or equal to 2.8 g/dL
  8. Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  9. Patients must be at least 18 years of age.
  10. Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing a highly effective form of contraception during the study treatment and for 8 weeks after stopping the treatment.

Highly effective contraception methods include combination of any of the following (NOTE: Estrogen containing contraceptives are prohibited):

  • Use of oral, injected, or implanted hormonal methods of contraception or;
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS);
  • Barrier methods of contraception: condom or occlusive cap (diaphgram or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository;
  • Total abstinence or;
  • Male/female sterilization. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.

Exclusion criteria

  1. Patients who have previously received any CDK4/6 inhibitor.
  2. Patients with clear cell, serous, carcinosarcoma, mixed histology endometrial cancers, or uterine sarcomas.
  3. Known intolerance or hypersensitivity to abemaciclib or letrozole.
  4. Patients who have previously received hormonal therapy for endometrial cancer.
  5. Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.
  6. Patients receiving chronic treatment with systemic steroids or another immunosuppressive agent.
  7. Patients with active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]). Screening is not required for enrollment.
  8. Patients with a serious pre-existing medical condition(s) that would preclude participation in this study (for example: interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (i.e. estimated creatinine clearance <30ml/min), history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or pre-existing chronic condition resulting in baseline grade 2 or higher diarrhea).
  9. Patients with a known history of cardiac disease. This includes:

    • Uncontrolled hypertension, defined as systolic greater than 150mm Hg or diastolic greater than 90mm Hg despite antihypertensive medications
    • Myocardial infarction or unstable angina within 6 months prior to registration.
    • New York Heart Association (NYHA) Class II or greater congestive heart failure.
    • History of serious ventricular arrhythmia (i.e. ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication, syncope of cardiovascular etiology or sudden cardiac arrest. This does not include asymptomatic atrial fibrillation with controlled ventricular rate.
    • Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months prior to the first date of study therapy.
  10. Patients who are pregnant or breast-feeding.
  11. Patients with known central nervous system metastases.
  12. Patients with known human immunodeficiency virus (HIV) infection.
  13. Patients with an impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of abemaciclib (i.e. ulcerative disease; uncontrolled nausea, vomiting and/or diarrhea; malabsorption syndrome; clinical signs and symptoms of gastrointestinal obstruction; and/or patients who require parenteral hydration and/or nutrition).
  14. Patients who plan to receive live attenuated vaccines within 1 week of start of abemaciclib and during the study. Patients should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines.
  15. Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder or coagulopathy.
  16. Patients with history of unprovoked venous thrombosis unless taking anticoagulation treatment for duration of trial.
  17. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days prior to dosing.

Sites / Locations

  • University of South Alabama Mitchell Cancer CenterRecruiting
  • Alaska Women's Cancer CareRecruiting
  • Smillow Cancer Care at GreenwichRecruiting
  • Yale UniversityRecruiting
  • Yale UniversityRecruiting
  • Sylvester Comprehensive Cancer Center-Lennar Foundation Medical CenterRecruiting
  • Sylevester Comprehensive Cancer Center-Deerfield BeachRecruiting
  • UF Health Cancer CenterRecruiting
  • University of Miami - Sylvester Cancer CenterRecruiting
  • UT Health TowerRecruiting
  • Advent Health - OrlandoRecruiting
  • Sylvester Comprehensive Cancer Center-PlantationRecruiting
  • Cleveland Clinic FloridaRecruiting
  • Lewis Cancer & Research PavilionRecruiting
  • University of ChicagoRecruiting
  • Baptist Healthcare SystemRecruiting
  • Tufts Medical CenterRecruiting
  • University of MassachusettsRecruiting
  • St. Joseph Mercy HospitalRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Holy Name Medical CenterRecruiting
  • Columbia University Medical CenterRecruiting
  • SUNY Upstate Medical UniversityRecruiting
  • Oklahoma Cancer Specialists and Research InstituteRecruiting
  • Reading Hospital-McGlinn Cancer InstituteRecruiting
  • Abington Memorial HospitalRecruiting
  • Baptist Health Center LexingtonRecruiting
  • Huntsman Cancer InstituteRecruiting
  • University of VirginiaRecruiting
  • West Virginia UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abemaciclib and Letrozole

Arm Description

Study treatment will consist of abemaciclib 150mg orally twice a day and letrozole 2.5mg orally once a day.

Outcomes

Primary Outcome Measures

Progression-free survival
To evaluate the efficacy in terms of the probability of surviving progression free for at least 6 months (PFS at 6 mo)

Secondary Outcome Measures

Response rate
To determine the proportion responding by RECIST v1.1 in patients with advanced, persistent, or recurrent endometrioid endometrial cancer
Time to disease progression or death
To estimate the time to disease progression or death (PFS and OS endpoints).
Toxicity Assessment of Adverse Events
To describe the toxicities in patients receiving combination therapy with letrozole and abemaciclib

Full Information

First Posted
May 11, 2020
Last Updated
March 16, 2023
Sponsor
Gynecologic Oncology Group
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04393285
Brief Title
Abemaciclib and Letrozole to Treat Endometrial Cancer
Official Title
A Phase II Study of Abemaciclib in Combination With Letrozole in Advanced, Recurrent or Metastatic Endometroid Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase II single arm trial to determine the percentage of patients without evidence of disease progression on abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer at 6 months. Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abemaciclib and Letrozole
Arm Type
Experimental
Arm Description
Study treatment will consist of abemaciclib 150mg orally twice a day and letrozole 2.5mg orally once a day.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Intervention Description
Abemaciclib 150mg orally twice a day
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Letrozole 2.5mg orally once a day
Primary Outcome Measure Information:
Title
Progression-free survival
Description
To evaluate the efficacy in terms of the probability of surviving progression free for at least 6 months (PFS at 6 mo)
Time Frame
From date of protocol entry to date of first documented progression up to 6 months
Secondary Outcome Measure Information:
Title
Response rate
Description
To determine the proportion responding by RECIST v1.1 in patients with advanced, persistent, or recurrent endometrioid endometrial cancer
Time Frame
From date of protocol entry to date of first response assessed up to 5 years
Title
Time to disease progression or death
Description
To estimate the time to disease progression or death (PFS and OS endpoints).
Time Frame
From date of protocol entry to date of progression or death assessed up to 5 years
Title
Toxicity Assessment of Adverse Events
Description
To describe the toxicities in patients receiving combination therapy with letrozole and abemaciclib
Time Frame
Every 4 weeks assessed up to 5 years
Other Pre-specified Outcome Measures:
Title
Protein expression analysis of Cyclin D and E Pathway
Description
Perform multiplexed protein expression analysis at a single cell level using imaging mass cytometry (IMC), exploring the relationship to response, and assessing for longitudinal changes upon progression/relapse. Cyclin D and E Pathway: Protein expression of CCND1, CDK4, CDK6, RB1, phospho-RB1, CDKN2A, CCNE1, CCNE2, CDK2, CCND3
Time Frame
At time of primary and secondary outcome analysis up to 5 years
Title
Protein expression analysis of Immune Cell Infiltration and activity
Description
Perform multiplexed protein expression analysis at a single cell level using imaging mass cytometry (IMC), exploring the relationship to response, and assessing for longitudinal changes upon progression/relapse. Immune cell infiltration and activity: CD45, CD3, CD8, CD4, FoxP3, PD-1, Tim-3, CTLA-4, CD25, Ki67.
Time Frame
At time of primary and secondary outcome analysis up to 5 years
Title
Protein expression analysis of sex hormone/insulin/IGF pathway
Description
Perform multiplexed protein expression analysis at a single cell level using imaging mass cytometry (IMC), exploring the relationship to response, and assessing for longitudinal changes upon progression/relapse. Sex hormone/insulin/IGF pathway: Protein expression of ER (ESR1), PR, IR, IGF1R, and phospho-IGF1R/IR
Time Frame
At time of primary and secondary outcome analysis up to 5 years
Title
Cyclin D1 3'UTR mutations
Description
Determine the frequency of Cyclin D1 3'UTR mutations and correlatioin with response.
Time Frame
At time of primary and secondary outcome analysis up to 5 years
Title
Estradiol levels
Description
Compare the pre- and post-treatment circulating estradiol levels, and association with response.
Time Frame
At time of primary and secondary outcome analysis up to 5 years
Title
Insulin levels
Description
Compare the pre- and post-treatment circulating insulin levels, and association with response.
Time Frame
At time of primary and secondary outcome analysis up to 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must have advanced (FIGO 2014 Stage III or IV), persistent, or recurrent endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy. Histologic confirmation of recurrent disease is required. For cases of persistent disease, histologic confirmation of the primary disease with radiologic evidence of progression is required. Patients must have endometrioid histology (all grades allowed) based on hysterectomy or biopsy specimen (Hormone receptor status is not required for enrollment). Sites are required to report results of previous MMR, MSI, and ER/PR status testing in Medidata Rave if available. All patients must have measurable disease. Measurable disease is defined by RECIST version 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15mm in short axis when measured by CT or MRI. Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy. Prior chemotherapy in the adjuvant setting for Stage I, II, or III is permitted. Prior chemoradiotherapy for a pelvic recurrence is permitted. Note: Chemotherapy in the setting of Stage IV disease is permitted but the patient must be without evidence of disease at the completion of chemotherapy and have at least six months of progression-free survival since the completion of chemotherapy before detection of the recurrent cancer for which she is receiving treatment on this protocol. Prior immunotherapy and/or targeted therapy is allowed in addition to, in combination with, in lieu of, or subsequent to prior chemotherapy. Regardless of circumstances, no more than one prior chemotherapy regimen (including chemo-radiotherapy) is permitted, and no more than one additional systemic therapy is permitted. Hence, eligible patient may have received 0, 1, or 2 prior lines of systemic therapy and for women who received two prior lines of therapy, only one of them may have included chemotherapy. Patients who received prior chemotherapy, immunotherapy or targeted therapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last systemic therapy dose and initiation of therapy. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and initiation of therapy. Patient must be able to swallow oral medications. Patient must have an ECOG performance status of 0 to 1. Patients must have adequate organ and marrow function as defined below NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1500/mcl Platelets greater than or equal to 100,000 cells/mcl Hemoglobin greater than or equal to 8 g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after erythrocyte transfusion). Renal function: • Creatinine less than or equal to 1.5 x ULN Hepatic function: Bilirubin less than or equal to 1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2 times ULN and direct bilirubin within normal limits are permitted). ALT (alanine aminotransferase) and AST (aspartate aminotransferase) less than or equal to 3 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN Albumin greater than or equal to 2.8 g/dL Patients must have signed an approved informed consent and authorization permitting release of personal health information. Patients must be at least 18 years of age. Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing a highly effective form of contraception during the study treatment and for 8 weeks after stopping the treatment. Highly effective contraception methods include combination of any of the following (NOTE: Estrogen containing contraceptives are prohibited): Use of oral, injected, or implanted hormonal methods of contraception or; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Barrier methods of contraception: condom or occlusive cap (diaphgram or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; Total abstinence or; Male/female sterilization. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential. Exclusion criteria Patients who have previously received any CDK4/6 inhibitor. Patients with clear cell, serous, carcinosarcoma, mixed histology endometrial cancers, or uterine sarcomas. Known intolerance or hypersensitivity to abemaciclib or letrozole. Patients who have previously received hormonal therapy for endometrial cancer. Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol. Patients receiving chronic treatment with systemic steroids or another immunosuppressive agent. Patients with active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]). Screening is not required for enrollment. Patients with a serious pre-existing medical condition(s) that would preclude participation in this study (for example: interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (i.e. estimated creatinine clearance <30ml/min), history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or pre-existing chronic condition resulting in baseline grade 2 or higher diarrhea). Patients with a known history of cardiac disease. This includes: Uncontrolled hypertension, defined as systolic greater than 150mm Hg or diastolic greater than 90mm Hg despite antihypertensive medications Myocardial infarction or unstable angina within 6 months prior to registration. New York Heart Association (NYHA) Class II or greater congestive heart failure. History of serious ventricular arrhythmia (i.e. ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication, syncope of cardiovascular etiology or sudden cardiac arrest. This does not include asymptomatic atrial fibrillation with controlled ventricular rate. Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months prior to the first date of study therapy. Patients who are pregnant or breast-feeding. Patients with known central nervous system metastases. Patients with known human immunodeficiency virus (HIV) infection. Patients with an impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of abemaciclib (i.e. ulcerative disease; uncontrolled nausea, vomiting and/or diarrhea; malabsorption syndrome; clinical signs and symptoms of gastrointestinal obstruction; and/or patients who require parenteral hydration and/or nutrition). Patients who plan to receive live attenuated vaccines within 1 week of start of abemaciclib and during the study. Patients should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines. Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder or coagulopathy. Patients with history of unprovoked venous thrombosis unless taking anticoagulation treatment for duration of trial. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days prior to dosing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Klein, MEd
Phone
2158540770
Email
jklein@gog.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn Huang, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
University of South Alabama Mitchell Cancer Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanie Broemmelsiek
Email
jbroemmelsiek@health.southalabama.edu
First Name & Middle Initial & Last Name & Degree
Rodney Rocconi, MD
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Fulcher
Email
christina.fulcher@providence.org
First Name & Middle Initial & Last Name & Degree
Melissa Hardesty, MD
Facility Name
Smillow Cancer Care at Greenwich
City
Greenwich
State/Province
Connecticut
ZIP/Postal Code
06830
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Baker
Email
lisa.baker@yale.edu
First Name & Middle Initial & Last Name & Degree
Gloria Huang, MD
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Baker
Email
lisa.baker@yale.edu
First Name & Middle Initial & Last Name & Degree
Gloria Huang, MD
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Baker
Email
lisa.baker@yale.edu
First Name & Middle Initial & Last Name & Degree
Gloira Huang, MD
Facility Name
Sylvester Comprehensive Cancer Center-Lennar Foundation Medical Center
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Calvo
Email
mxc2641@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Marilyn Huang, MD
Facility Name
Sylevester Comprehensive Cancer Center-Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Calvo
Email
mxc2641@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Marilyn Huang, MD
Facility Name
UF Health Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Geckler
Email
d.geckler@ufl.edu
First Name & Middle Initial & Last Name & Degree
Martina Murphy, MD
Facility Name
University of Miami - Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Garcia
Email
rxg1051@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Aaron Wolfson, MD
Facility Name
UT Health Tower
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica M Calvo
Email
mxc2641@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Marilyn Huang, MD
Facility Name
Advent Health - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Coakley
Email
susan.coakley@adventhealth.com
First Name & Middle Initial & Last Name & Degree
Robert Holloway, MD
Facility Name
Sylvester Comprehensive Cancer Center-Plantation
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica M Calvo
Email
mxc2641@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Marilyn Huang, MD
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Dimayuga
Email
dimayum@ccf.org
First Name & Middle Initial & Last Name & Degree
Timmy Nguyen, MD
Facility Name
Lewis Cancer & Research Pavilion
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joni Shortt
Email
SHORTTJ@sjchs.org
First Name & Middle Initial & Last Name & Degree
Sarah Gill, MD
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penny Dolan
Email
pdolan@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
John Moroney, MD
Facility Name
Baptist Healthcare System
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Higgins
Email
mailto:Lauren.Higgins@bhsi.com
First Name & Middle Initial & Last Name & Degree
Monica Vetter, MD
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Carney
Email
mcarney@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Sarah Paraghamian, MD
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Allen
Email
indsey.allen@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Susan Zweizig, MD
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Velfling
Email
Christina.Velfling@stjoeshealth.org
First Name & Middle Initial & Last Name & Degree
Rebecca Liu, MD
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Bicomong
Email
mb1444@cinj.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Aliza Leiser, MD
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patty Kiledjian
Email
pkiledjian@holyname.org
Email
pkiledjian@holyname.org
First Name & Middle Initial & Last Name & Degree
Sharon Lewin, MD
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reena Vattakalam
Email
rmv2110@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Jason Wright, MD
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Bingham
Email
binghame@upstate.edu
First Name & Middle Initial & Last Name & Degree
Mary Cunningham, MD
Facility Name
Oklahoma Cancer Specialists and Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Powell
Email
melissa.powell@ocsri.org
First Name & Middle Initial & Last Name & Degree
Michael Gold, MD
Facility Name
Reading Hospital-McGlinn Cancer Institute
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Trexler
Email
Kim.Trexler@towerhealth.org
First Name & Middle Initial & Last Name & Degree
Bernice Robinson-Bennett, MD
Facility Name
Abington Memorial Hospital
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Reilly
Email
shannon.reilly@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Mark Shahin, MD
Facility Name
Baptist Health Center Lexington
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Higgins
Email
Lauren.Higgins@bhsi.com
First Name & Middle Initial & Last Name & Degree
Monica Vetter, MD
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janna Espinosa
Email
Janna.Espinosa@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Theresa Werner, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Gabel
Email
AM7BD@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Kari Ring, MD
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Moore
Email
deborah.moore@hsc.wvu.edu
First Name & Middle Initial & Last Name & Degree
Krista Pfaendler, MD

12. IPD Sharing Statement

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Abemaciclib and Letrozole to Treat Endometrial Cancer

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