NCT03665077

Brief Summary

This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 14, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

4.3 years

First QC Date

September 7, 2018

Results QC Date

April 24, 2023

Last Update Submit

August 10, 2023

Conditions

Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS)Breast Cancer

Keywords

Aromatase Inhibitor Induced Musculoskeletal SyndromeAIMSSBreast CancerBiomarkersOxylipin

Outcome Measures

Primary Outcomes (1)

  • Oxylipin Levels

    Change Oxylipin levels at Baseline, Three and Six Months

    Baseline, Three months, and Six months

Secondary Outcomes (2)

  • Tendon Stiffness

    Baseline

  • Pain Levels

    Baseline, Six months

Study Arms (1)

Participants

EXPERIMENTAL

Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.

Diagnostic Test: Initial blood drawDiagnostic Test: Initial SWE ultrasoundDiagnostic Test: Blood draw at three monthsDiagnostic Test: Blood draw at six monthsDiagnostic Test: SWE ultrasound at six months

Interventions

Initial blood drawDIAGNOSTIC_TEST

At baseline, patients will undergo a blood draw.

Participants
Initial SWE ultrasoundDIAGNOSTIC_TEST

At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.

Participants
Blood draw at three monthsDIAGNOSTIC_TEST

Blood drawn at three months to evaluate oxylipins.

Participants
Blood draw at six monthsDIAGNOSTIC_TEST

Blood drawn at six months to evaluate oxylipins.

Participants
SWE ultrasound at six monthsDIAGNOSTIC_TEST

SWE ultrasound at six months to evaluate tendon stiffness.

Participants

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPost-menopausal women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
  • Be capable of signing and providing written consent in accordance with institutional and federal guidelines
  • Have a histologically-confirmed diagnosis of breast cancer
  • Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging
  • Age ≥ 21 years
  • Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3)
  • Completed definitive therapy (surgery ± radiation)
  • Candidates for adjuvant AI therapy

You may not qualify if:

  • Have received adjuvant or neo-adjuvant chemotherapy
  • Prior endocrine therapy (AI or tamoxifen)
  • History of rheumatoid arthritis or other autoimmune arthritis
  • Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)
  • Current use of daily corticosteroids or immunosuppressive therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Pavani Chalasani
Organization
George Washington Cancer Center
pavani.chalasani@email.gwu.edu
(202)-741-2277

Study Officials

  • Pavani Chalasani

    University of Arizona

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 11, 2018

Study Start

February 28, 2018

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

August 24, 2023

Results First Posted

August 14, 2023

Record last verified: 2023-08

Locations

US(1)