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New treatment option for Breast Neoplasms
Official title Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
ClinicalTrials.gov ID: NCT07214532
What this study is testing
- What it's testing
- 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.
- Time commitment: about 9 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specific screening procedure.
- Patient is ≥ 18 years-old at the time of ICF signature.
- Patient is female with known menopausal status at the time of initiation of adjuvant endocrine therapy (ET), or male.
- Patient with histologically confirmed unilateral and unifocal primary invasive adenocarcinoma of the breast prior to initiating adjuvant...
- Patient has breast cancer that is positive for ER and/or PR according to the local laboratory as determined on the most recently analyzed tissue...
You likely can't join if
- Patient has had prior exposure to a CDK4/6 inhibitor.
- Patient is concurrently using hormone replacement therapy.
- Patient with a known contraindication or hypersensitivity to ribociclib or abemaciclib as per the FDA indication label.
- Patients with a multicentric and/or multifocal and synchronous contralateral breast cancer are ineligible.
- Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence...
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 5 years before ICF signature. Note...
See the full eligibility criteria
Who can join
- Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specific screening procedure.
- Patient is ≥ 18 years-old at the time of ICF signature.
- Patient is female with known menopausal status at the time of initiation of adjuvant endocrine therapy (ET), or male.
- Patient with histologically confirmed unilateral and unifocal primary invasive adenocarcinoma of the breast prior to initiating adjuvant chemotherapy, if indicated, or within 6 months of initiating adjuvant endocrine...
- Patient has breast cancer that is positive for ER and/or PR according to the local laboratory as determined on the most recently analyzed tissue sample.
- Patient has HER2-negative breast cancer defined as a negative in situ hybridization test (FISH, CISH, or SISH) or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (ISH)...
- Patient has available archival tumor tissue from the diagnostic biopsy or surgical specimen, for submission to a central laboratory for Signatera testing (unless Signatera Genome clinical testing has already been...
- Patient after surgical resection where tumor was removed completely (i.e., negative microscopic margins on final pathology) and have Anatomic Stage II that is either:
- N1 or,
- If N0, T2 or T3 with G2-3 and/or Ki67≥20% (testing for Ki67 not mandatory), excluding G1. Notes:
- Patients who received neoadjuvant treatment must meet the criteria for stage, grade, Ki67 in any presurgical staging/sample and/or in the surgical specimen.
- Categorization into the AJCC 8th edition Anatomic Stage Groups requires determination of the T, N and M categories. ALND can be omitted.
- Patient has no contraindication to adjuvant ET and is planned to be treated with ET for 5 years (since enrollment date) or more.
- Provider and patient must be agreeable to initiate CDK4/6 inhibitors only upon ctDNA detection.
- Patient may have received up to 6 months of standard adjuvant ET at the time of enrollment and any amount of neoadjuvant endocrine therapy.
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Patient must not have a clinical contraindication to ribociclib or abemaciclib.
- Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
- Women of childbearing potential (CBP) must have a confirmed negative serum pregnancy test within 14 days prior to enrollment.
- Women of reproductive potential should be advised of the potential risk of CDK4/6 inhibitors to a fetus, and use effective contraception during CDK 4/6 inhibitor therapy.
What rules you out
- Patient has had prior exposure to a CDK4/6 inhibitor.
- Patient is concurrently using hormone replacement therapy.
- Patient with a known contraindication or hypersensitivity to ribociclib or abemaciclib as per the FDA indication label.
- Patients with a multicentric and/or multifocal and synchronous contralateral breast cancer are ineligible.
- Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 5 years before ICF signature. Note: Patients with prior or concurrent in situ malignancies are eligible...
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or...
- Patient participated in another treatment study and received treatment with an investigational product (or used an investigational device) within 30 days prior to enrollment or within 5 half-lives of the investigational...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Bakersfield, California, United States
- Greenbrae, California, United States
- Loma Linda, California, United States
- Santa Monica, California, United States
- Stockton, California, United States
- Vallejo, California, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Jupiter, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- Chicago, Illinois, United States
- Dyer, Indiana, United States
- Westbrook, Maine, United States
- Detroit, Michigan, United States
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 9 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; Bakersfield, California, United States; Greenbrae, California, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.