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

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ClinicalTrials.gov Identifier: NCT03723928
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief 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.

Condition or disease Intervention/treatment Phase
Anatomic Stage IV Breast Cancer AJCC v8 Estrogen Receptor Positive HER2/Neu Negative Progesterone Receptor Positive Prognostic Stage IV Breast Cancer AJCC v8 Elevated CA15-3 or CEA or CA27-29 Other: Usual care disease monitoring Other: Serum Tumor Marker directed disease monitoring Other: Quality-of-Life Assessment Other: Anxiety Questionnaire Administration Not Applicable

Detailed 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 6 weeks. Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : July 15, 2027
Estimated Study Completion Date : July 15, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm I (usual care)
Patients will have imaging studies (modality and frequency per treating physician, however at a minimum frequency of every 12 weeks) alone or in conjunction with STMs (frequency determined by treating physician). Patients will continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression.
Other: Usual care disease monitoring
Imaging and serum tumor markers are at the discretion of the treating physician (however imaging must be performed at least every 12 weeks).

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Anxiety Questionnaire Administration
Ancillary studies

Experimental: Arm II (serum tumor directed disease monitoring)
Patients undergo disease specific serum tumor marker evaluation (CA 15-3, CA 27.29 and CEA) every 6 weeks without imaging until an elevation of at least one disease specific STM. In the event of an elevated STM, the patient will have imaging within 4 weeks to evaluate for disease progression. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.
Other: Serum Tumor Marker directed disease monitoring
Serum tumor markers every 6 weeks without imaging
Other Name: STMDDM

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Anxiety Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care [ Time Frame: Up to 312 weeks after randomization ]
    The assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care will be based on multivariable Cox regression, adjusting for intervention assignment (intention-to-treat) and the stratification factor (bone only versus visceral disease). If at the time of final analysis the study shows notably fewer events than anticipated, extended follow-up will be examined for its potential to allow examination of the primary endpoint with full power.


Secondary Outcome Measures :
  1. Cumulative direct healthcare costs of patients monitored with STMDDM versus usual care [ Time Frame: Up to 48 weeks after randomization ]
    The comparison of direct healthcare costs by arm will be based on a multivariable linear regression, adjusting for patient and tumor characteristics.

  2. Assessment of anxiety of patients monitored with STMDDM compared to patients monitored with usual care [ Time Frame: Up to 102 weeks after randomization ]
    Patient anxiety will be measured at baseline and at 12, 24, 36, 48, and 102 after randomization using the State-Trait Anxiety inventory Scale (STAI-S). Differences in anxiety by arm will be evaluated using a mixed-effects model for repeated measures controlling for the baseline score and stratification factor as covariates. No direction of effect will be assumed, implying two-sided testing.

  3. Assessment of quality of life of patients monitored with STMDDM versus patients monitored with usual care [ Time Frame: Up to 102 weeks after randomization ]
    Patient quality of life (QOL) will be measured at baseline and at weeks 12, 24, 36, 48, and 102 after randomization using the PROMIS-29. Differences in QOL by arm will be evaluated using a mixed-effects model for repeated measures, controlling for the baseline score and stratification factor as covariates. No direction of effect will be assumed, implying two-sided testing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

    • 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 28 days after start of first-line systemic treatment for metastatic disease
  • Patients must have been tested for all of 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:

    • CA 15-3
    • CA 27.29
    • CEA
    • At least one of these STMs must have been >= 2 x the institutional upper limit of normal at this time
  • Patients must have systemic radiographic imaging prior to initiation of systemic therapy for treatment of metastatic breast cancer and prior to step 1 registration with either:

    • A computed tomography (CT) scan of the chest and abdomen with or without CT pelvis, and with or without bone scan or
    • A positron emission tomography (PET) scan with or without CT
    • 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) at their current center for the duration of the study intervention (312 weeks after step 2 randomization)
  • 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 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 treatment regimen initiated no more than 28 days prior to registration
  • 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 all of the following breast cancer specific STMs between 56 and 112 days after initiation of first-line systemic therapy for metastatic disease:

    • CA 15-3
    • CA 27.29
    • CEA
  • At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by >= 25% 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 112 days after the initiation of first-line systemic therapy for metastatic disease; 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723928


  Show 495 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Melissa Accordino Southwest Oncology Group

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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT03723928     History of Changes
Other Study ID Numbers: S1703
NCI-2018-00090 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1703 ( Other Identifier: SWOG )
SWOG-S1703 ( Other Identifier: DCP )
S1703 ( Other Identifier: CTEP )
UG1CA189974 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs