Is NCT07214532 recruiting in Loma Linda, CA?

Yes, NCT07214532 is currently recruiting participants at its Loma Linda, CA location. This breast neoplasms clinical trial is actively enrolling qualified participants.

How do I join the breast neoplasms clinical trial in Loma Linda?

To join this clinical trial in Loma Linda, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Loma Linda clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Breast Neoplasms Clinical Trial in Loma Linda, CA

About This Breast Neoplasms Study in Loma Linda

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.

Sponsor: Natera, Inc.

Who Can Participate

Inclusion Criteria

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 therapy if chemotherapy is not indicated. Patients who receive neoadjuvant endocrine therapy or chemotherapy are allowed to enroll.

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) test is required to confirm the HER2-negative status.

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 performed).

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:

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.

Exclusion Criteria

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 provided that adequate curative treatment is completed prior to enrollment.

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 compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.) or limit life expectancy to ≤5 years.

Patient participated in another interventional 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 product, whichever is longer.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Loma Linda?

Yes, this clinical trial (NCT07214532) has an active research site in Loma Linda, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Breast Neoplasms Treatment Options in Loma Linda, CA

If you're searching for breast neoplasms treatment options in Loma Linda, CA, this clinical trial (NCT07214532) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Loma Linda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast neoplasms specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all breast neoplasms clinical trials near you to find additional studies recruiting in your area.

Breast Neoplasms Clinical Trial in Loma Linda, CA

Expert Care in Loma Linda

IRB Approved

No-Cost Care

Apply for This Loma Linda Location

Why Participate?

Simple Process