S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jul 15, 2027
  • participants needed
    1320
  • sponsor
    Southwest Oncology Group
Updated on 3 March 2021

Summary

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.

Description

PRIMARY OBJECTIVES:

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 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.

TERTIARY 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.

Details
Condition Estrogen Receptor Positive, Progesterone Receptor Positive, Anatomic Stage IV Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Elevated CA15-3, Elevated CEA, Elevated Serum CA 27-29 Tumor Antigen Levels, HER2/Neu Negative, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29, HER2/Neu Negative, Elevated CA15-3 or CEA or CA27-29
Treatment quality-of-life assessment, Usual care disease monitoring, Serum Tumor Marker directed disease monitoring, Anxiety Questionnaire Administration
Clinical Study IdentifierNCT03723928
SponsorSouthwest Oncology Group
Last Modified on3 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: HER2/Neu Negative or Elevated CA15-3 or CEA or CA27-29 or Prognostic Stage IV Breast Cancer AJCC v8 or Anatomic Stage IV Breast Cancer AJCC v8 or Estr...?
Do you have any of these conditions: Elevated CA15-3 or Elevated CA15-3 or CEA or CA27-29 or Estrogen Receptor Positive or Prognostic Stage IV Breast Cancer AJCC v8 or HER2/Neu Negative o...?
Do you have any of these conditions: Prognostic Stage IV Breast Cancer AJCC v8 or Elevated CA15-3 or Estrogen Receptor Positive or Elevated Serum CA 27-29 Tumor Antigen Levels or HER2/Neu...?
Do you have any of these conditions: Elevated Serum CA 27-29 Tumor Antigen Levels or Elevated CA15-3 or CEA or CA27-29 or Progesterone Receptor Positive or Prognostic Stage IV Breast Canc...?
Do you have any of these conditions: Elevated Serum CA 27-29 Tumor Antigen Levels or Elevated CA15-3 or CEA or CA27-29 or Estrogen Receptor Positive or Elevated CEA or Anatomic Stage IV B...?
Do you have any of these conditions: Elevated Serum CA 27-29 Tumor Antigen Levels or Elevated CA15-3 or Elevated CA15-3 or CEA or CA27-29 or HER2/Neu Negative or Progesterone Receptor Pos...?
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 >= 2 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 except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for five years
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
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)
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