Is NCT03723928 recruiting in Fairbanks, AK?

Yes, NCT03723928 is currently recruiting participants at its Fairbanks, AK location. This anatomic stage iv breast cancer ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Fairbanks 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.

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial in Fairbanks, AK

Q: How do I join the anatomic stage iv breast cancer ajcc v8 clinical trial in Fairbanks?

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

About This Anatomic Stage IV Breast Cancer AJCC v8 Study in Fairbanks

This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.

Sponsor: SWOG Cancer Research Network

Who Can Participate

Inclusion Criteria

STEP 1 REGISTRATION

Patients must have a diagnosis of hormone receptor positive (estrogen receptor positive \[ER+\] and/or progesterone receptor positive \[PR+\]), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease. (Systemic treatment is any treatment meant to treat the whole body such as endocrine therapy +/- targeted therapy +/- chemotherapy).

NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and/or recurrent breast cancer from an earlier stage that is now metastatic

Patients must be registered to step 1 between 14 days prior to and 60 days after start of first-line systemic treatment for metastatic disease

Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within +/-14 days of initiation of first-line systemic treatment for metastatic disease:

CEA (must be tested)

CA 15-3 or CA 27.29 (at least one of these must be tested)

At least one of the tested STMs must have been \>= 1.5 x the institutional upper limit of normal at this time. Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.

Patients must have systemic radiographic imaging prior to initiation of systemic therapy or within 30 days of initiation of treatment for metastatic breast cancer and prior to step 1 registration. Modality of imaging is at the discretion of the treating physician.

Note: the treating physician can order additional imaging tests at any point prior to randomization at their discretion

Patients must be willing to obtain disease monitoring (imaging and/or serum tumor markers) from a consistent facility in which the registering site has access to the results for the duration of the study intervention (312 weeks after step 2 randomization). Imaging and STMs do not need to be completed at the same facility.

Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels

Patients with known brain leptomeningeal metastases are not eligible as they may require regular radiographic monitoring to assess treatment response

Patients must not be currently enrolled or plan to participate in a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule

Patients who are able to complete questionnaires in English or Spanish must participate in patient-reported outcome (PRO) assessments

Patients must not be pregnant due to the potential harm to the fetus from radiation exposure from radiographic imaging

Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed with the following exceptions:

Adequately treated basal (or squamous cell) skin cancer

Any cancer from which the patient has been disease free for five years

Prior Stage 0 or pre-cancerous lesions that have been removed with clear margins

Patients must not have received prior systemic therapy for metastatic breast cancer, except for their current line of therapy.

Patients must have decision making capacity and be able to provide informed consent

Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; use of legally-authorized representative is not permissible for this study. Remote consent is allowed with adequate documentation.

As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

STEP 2 RANDOMIZATION

Patients must be tested for the breast cancer specific STMs that were tested prior to STEP 1 Registration between 56 and 140 days after initiation of first-line systemic therapy for metastatic disease:

CEA (must be tested)

CA 15-3 or CA 27.29 (whichever was tested prior to Step 1) Testing all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.

At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by \>= 10% at this time.

Patients must not have known progression since registration to step 1

Patients must be registered to step 2 randomization between 56 days and 140 days after the initiation of first-line systemic therapy for metastatic disease; This window is inclusive; patients may be registered to Step 2 on day 56 or Day 140. Patients must have been eligible for Step 1 in order to be eligible for Step 2 Randomization

Baseline questionnaires must be completed within 28 days prior to step 2 randomization; (Note: Those patients who cannot complete the PRO questionnaires in English or Spanish can be registered to step 2 without contributing to PRO research)

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 Fairbanks?

Yes, this clinical trial (NCT03723928) has an active research site in Fairbanks, AK 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.

Anatomic Stage IV Breast Cancer AJCC v8 Treatment Options in Fairbanks, AK

If you're searching for anatomic stage iv breast cancer ajcc v8 treatment options in Fairbanks, AK, this clinical trial (NCT03723928) 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 Fairbanks research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anatomic stage iv breast cancer ajcc v8 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 anatomic stage iv breast cancer ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Anatomic Stage IV Breast Cancer AJCC v8 Clinical Trial in Fairbanks, AK

Expert Care in Fairbanks

IRB Approved

No-Cost Care

Apply for This Fairbanks Location

Why Participate?

Simple Process