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Serum Tumor Marker Directed Disease Monitoring in Monitoring Patients with Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Health services research
NCT ID
NCT03723928
Protocol IDs
S1703 (primary)
S1703
SWOG-S1703
NCI-2018-00090
Study Sponsor
SWOG

Summary

This 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 (metastatic). Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.

Objectives

PRIMARY OBJECTIVE:
I. To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care.

SECONDARY OBJECTIVES:
I. To compare cumulative direct healthcare costs (in the United States) through 48 weeks among patients monitored with STMDDM versus those monitored with usual care in this patient population.
II. To assess whether the patient-reported outcomes (PROs) of anxiety and quality of life (QOL) are different among patients who are monitored with STMDDM compared with patients who are monitored with usual care in this patient population.

OTHER OBJECTIVES:
I. To assess modality and frequency of disease monitoring testing in the usual care cohort.
II. To assess the association of PROs and patient preferences for disease monitoring testing.
III. To evaluate predictors of physician preferences for disease monitoring testing.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients undergo imaging studies at a minimum frequency of every 12 weeks and continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression.

ARM II: Patients undergo disease specific serum tumor marker (STM) evaluation every 4-8 weeks. Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.

Eligibility

  1. STEP 1 REGISTRATION
  2. 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
  3. 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
  4. 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 these 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
  5. 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
  6. 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
  7. Patients who are able to complete questionnaires in English or Spanish must participate in patient-reported outcome (PRO) assessments
  8. Patients must have decision making capacity and be able to provide informed consent
  9. 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
  10. 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
  11. STEP 2 RANDOMIZATION
  12. 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
  13. At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by >= 10% at this time
  14. 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 on day 140. Patients must have been eligible for step 1 in order to be eligible for step 2 randomization.
  15. 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)
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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