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New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT03723928
What this study is testing
- What it's testing
- 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.
- Time commitment: about 312 weeks
- Which group you join is decided by chance.
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
- STEP 1 REGISTRATION
- Patients must have a diagnosis of hormone receptor positive (estrogen receptor positive [ER+] and/or progesterone receptor positive [PR+]), HER-2...
- 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...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Fairbanks, Alaska, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fort Smith, Arkansas, United States
- Hot Springs, Arkansas, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Arroyo Grande, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Burbank, California, United States
- Cameron Park, California, United States
- Carmichael, California, United States
- Dublin, California, United States
- Elk Grove, California, United States
- Emeryville, California, United States
- Fontana, California, United States
+ 448 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 312 weeks 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 Anchorage, Alaska, United States; Fairbanks, Alaska, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Fort Smith, Arkansas, United States and 462 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.