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Trial record 1 of 10 for:    Bagegni
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Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing

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ClinicalTrials.gov Identifier: NCT04968964
Recruitment Status : Not yet recruiting
First Posted : July 20, 2021
Last Update Posted : December 22, 2021
Sponsor:
Collaborator:
Biovica
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems.

The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.


Condition or disease Intervention/treatment Phase
Breast Cancer Cancer of the Breast Device: DiviTum® TKa assay Other: Study Care Plans Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: TK IMPACT: Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing: Physician Decision Impact Study
Estimated Study Start Date : January 31, 2022
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Cohort 1: Scheduled to receive first line therapy
  • Scheduled to receive 1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor
  • Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient & review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes
Device: DiviTum® TKa assay
-Determines serum enzymatic activity of TK1

Experimental: Cohort 2: Currently receiving first line therapy
  • 1st line therapy with endocrine therapy + any FDA-approved CDK 4/6 inhibitor for ≤ 24 months with stable disease
  • Serum samples (analyzed using DiviTum® TKa) at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months. Treating physician will evaluate the patient & review any updated results of the institutional standard of care monitoring tests. Following receipt of DiviTum® TKa value, the treating physician will review the preceding locked Study Care Plan and record any changes
Device: DiviTum® TKa assay
-Determines serum enzymatic activity of TK1

Experimental: Medical Oncologists
-Will be completing the Study Care Forms at Baseline, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24 and every 12 weeks thereafter until disease progression or 36 months.
Other: Study Care Plans
-Study Care Plans will be completed prior to and post release of serum DiviTum® TKa value




Primary Outcome Measures :
  1. Any physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa value [ Time Frame: Within the first 48-week period of study participation ]

Secondary Outcome Measures :
  1. Progression status [ Time Frame: At first on study imaging study (at approximately 3 months) ]
  2. Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values [ Time Frame: At 12 weeks ]
  3. Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values [ Time Frame: At 24 weeks ]
  4. Number of intended versus actual surveillance imaging scans used pre to post receipt of DiviTum® TKa level [ Time Frame: Over the entire study period (estimated to be 36 months) ]
  5. Longitudinal changes in DiviTum® TKa value dynamics [ Time Frame: Over the entire study period (estimated to be 36 months) ]
    The TK trajectory of a patients will be plot against time for temporal pattern and the trajectories will be modeled via linear or non-linear mixed effects mode as appropriate. If linear mixed effects model, the longitudinal rate of change will be estimated with 95% CI to indicate growth rate of TK. If non-linear, the regression coefficients of time or time relevant terms will be estimated with 95% CI

  6. Cohort 1 only: DiviTum® TKa level [ Time Frame: At 2 weeks post CDK 4/6 inhibitor therapy initiation ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 - Patients:

  • Diagnosis of metastatic or advanced resectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Tumor assessment by radiographic imaging will be performed within 4 weeks of baseline study visit.
  • Cohort 1 only: Scheduled to initiate standard of care first-line therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for the stated diagnosis at the time of study enrollment. Type of endocrine therapy and CDK 4/6 inhibitor will be documented.
  • Cohort 2 only: Currently receiving first-line therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for no longer than 24 months with at least stable disease (no progression) on such therapy for a minimum of 12 weeks prior to enrollment as determined by radiographic studies as deemed appropriate by the treating physician. Type of endocrine therapy and CDK 4/6 inhibitor will be documented.
  • Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.
  • Cohorts 1 and 2: Prior receipt of adjuvant CDK 4/6 inhibitor therapy is permitted provided therapy completion occurred > 12 months prior to study enrollment.
  • At least 18 years of age.
  • Life expectancy > 6 months.
  • Post-menopausal status, defined as one of the following:

    • Age ≥ 60 years
    • Age < 60 with intact uterus and amenorrhea for 12 consecutive months or more
    • Status post bilateral oophorectomy, total hysterectomy
    • Pre- or peri-menopausal with suppressed ovarian function by use of GnRH agonist/antagonist or surgical bilateral oophorectomy
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria - Patients:

  • Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant setting.
  • A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
  • Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.

Eligibility Criteria - Physicians:

  • Medical Oncologist at Siteman Cancer Center
  • Treating patients with metastatic or advanced unresectable invasive breast cancer
  • Willing to complete Study Care Plans on a serial basis during participation

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): NCT04968964


Contacts
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Contact: Nusayba Bagegni, M.D. 314-273-3022 nbagegni@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Contact: Nusayba Bagegni, M.D.    314-273-3022    nbagegni@wustl.edu   
Principal Investigator: Nusayba Bagegni, M.D.         
Sub-Investigator: Foluso Ademuyiwa, M.D., MPH         
Sub-Investigator: Ron Bose, M.D.         
Sub-Investigator: Katherine Clifton, M.D.         
Sub-Investigator: Andrew Davis, M.D.         
Sub-Investigator: Ashley Frith, M.D.         
Sub-Investigator: Cynthia Ma, M.D., Ph.D.         
Sub-Investigator: Mateusz Opyrchal, M.D.         
Sub-Investigator: Lindsay Peterson, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Katherine Weilbaecher, M.D.         
Sub-Investigator: Jingqin (Rosy) Luo, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Biovica
Investigators
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Principal Investigator: Nusayba Bagegni, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04968964    
Other Study ID Numbers: 202107015
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
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