Actively Recruiting
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Led by Natera, Inc. · Updated on 2026-04-08
725
Participants Needed
39
Research Sites
614 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with intermediate-risk HR+/HER2- early-stage breast cancer. Based on ctDNA test results, participants will either start CDK4/6 inhibitor therapy in addition to hormone therapy or continue hormone therapy with ongoing ctDNA surveillance. This study will compare outcomes to historical controls from the NataLEE trial to determine whether ctDNA-guided timing maintains efficacy while reducing unnecessary treatment. Participants will be followed for up to 9 years with regular blood draws, hormone therapy, imaging as needed, and quality-of-life assessments.
CONDITIONS
Official Title
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form before any trial procedures
- Age 18 years or older at consent
- Female with known menopausal status or male
- Histologically confirmed unilateral and unifocal primary invasive breast adenocarcinoma before starting adjuvant chemotherapy or within 6 months of starting adjuvant endocrine therapy if no chemotherapy
- Breast cancer positive for estrogen receptor and/or progesterone receptor
- HER2-negative breast cancer confirmed by local lab testing
- Available archival tumor tissue for Signatera testing unless already done
- Completed surgical removal of tumor with negative margins
- Anatomic Stage II breast cancer with N1 or, if N0, T2 or T3 with grade 2-3 and/or Ki67 �320% (Ki67 testing not mandatory), excluding grade 1
- No contraindication to adjuvant endocrine therapy and planned to receive endocrine therapy for 5 years or more
- Agreement to start CDK4/6 inhibitors only if ctDNA is detected
- May have received up to 6 months of standard adjuvant endocrine therapy and any neoadjuvant endocrine therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- No clinical contraindication to ribociclib or abemaciclib
- Willing and able to comply with visits, treatment, labs, and procedures
- Women of childbearing potential must have negative serum pregnancy test within 14 days before enrollment
- Women of reproductive potential advised to use effective contraception during CDK4/6 inhibitor therapy
You will not qualify if you...
- Prior exposure to a CDK4/6 inhibitor
- Concurrent use of hormone replacement therapy
- Known contraindication or allergy to ribociclib or abemaciclib
- Multicentric, multifocal, or synchronous contralateral breast cancer
- Distant breast cancer metastases beyond regional lymph nodes or recurrence after curative surgery
- Concurrent invasive malignancy or prior invasive malignancy treated within 5 years
- Other severe or uncontrolled medical conditions posing safety risks or limiting compliance
- Participation in another interventional study with investigational product within 30 days or 5 half-lives before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
3
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
Not Yet Recruiting
4
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Not Yet Recruiting
5
Adventist Health/AIS Cancer Center
Bakersfield, California, United States, 93301
Not Yet Recruiting
6
Marin Cancer Care
Greenbrae, California, United States, 94904
Not Yet Recruiting
7
Loma Linda University
Loma Linda, California, United States, 92354
Not Yet Recruiting
8
UCLA David Geffen School of Medicine
Santa Monica, California, United States, 90404
Not Yet Recruiting
9
Stockton Hematology Oncology Medical Group
Stockton, California, United States, 95204
Actively Recruiting
10
Kaiser Permanente NorCal
Vallejo, California, United States, 94589
Not Yet Recruiting
11
Hartford Healthcare Institute
Hartford, Connecticut, United States, 06102
Not Yet Recruiting
12
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Not Yet Recruiting
13
Baptist MD Anderson
Jacksonville, Florida, United States, 32207
Not Yet Recruiting
14
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
15
Jupiter Medical Cancer
Jupiter, Florida, United States, 33458
Not Yet Recruiting
16
Miami Cancer Institute
Miami, Florida, United States, 33176
Not Yet Recruiting
17
Ocala Oncology
Ocala, Florida, United States, 34474
Not Yet Recruiting
18
Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
19
Northwest Cancer Center
Dyer, Indiana, United States, 46311
Actively Recruiting
20
New England Cancer Specialists
Westbrook, Maine, United States, 04092
Not Yet Recruiting
21
Karmanos Cancer Center - Wayne State University
Detroit, Michigan, United States, 48201
Not Yet Recruiting
22
Cancer & Hematology Centers
Grand Rapids, Michigan, United States, 49504
Not Yet Recruiting
23
Munson Medical Center Cowell Family Cancer Center
Traverse City, Michigan, United States, 49684
Not Yet Recruiting
24
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
25
Mercy Health - Sindelar Cancer Center
St Louis, Missouri, United States, 63128
Not Yet Recruiting
26
Mercy Health - Pratt Cancer Center
St Louis, Missouri, United States, 63141
Not Yet Recruiting
27
Cooper Health
Camden, New Jersey, United States, 08103
Not Yet Recruiting
28
Rutgers
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
29
New York Cancer and Blood Specialists
Babylon, New York, United States, 11702
Not Yet Recruiting
30
Atrium Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
31
Allegheny (AHN)
Pittsburgh, Pennsylvania, United States, 15212
Not Yet Recruiting
32
Sanford Health
Sioux Falls, South Dakota, United States, 57104
Not Yet Recruiting
33
West Cancer Center
Germantown, Tennessee, United States, 38138
Not Yet Recruiting
34
Vanderbilt
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
35
Houston Methodist Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
36
Northwest Medical Specialties, PLLC
Puyallup, Washington, United States, 98373
Not Yet Recruiting
37
Fred Hutch Cancer Center
Seattle, Washington, United States, 98109
Not Yet Recruiting
38
MultiCare Cancer Institute
Tacoma, Washington, United States, 98405
Not Yet Recruiting
39
West Virginia University
Morgantown, West Virginia, United States, 26506
Not Yet Recruiting
Research Team
K
Kayla Gelow, MS
CONTACT
J
Jessica Reyes, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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