Serum Tumor Marker directed disease monitoring for Stage IV Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
IHA Hematology Oncology Consultants-Ann Arbor, Ypsilanti, MIStage IV Breast Cancer+5 MoreSerum Tumor Marker directed disease monitoring - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial studies how well using markers to prompt when scans should be ordered works in monitoring patients with hormone receptor positive Her2 negative breast cancer.

Eligible Conditions
  • Stage IV Breast Cancer
  • Elevated Tumor Markers
  • HER2/Neu Negative Breast Cancer
  • Estrogen Receptor Positive
  • Progesterone Receptor Positive

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 48 weeks after randomization

Week 102
Assessment of anxiety of patients monitored with STMDDM compared to patients monitored with usual care
Assessment of quality of life of patients monitored with STMDDM versus patients monitored with usual care
Week 312
Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care
Week 48
Cumulative direct healthcare costs (in the United States) of patients monitored with STMDDM versus usual care

Trial Safety

Trial Design

2 Treatment Groups

Arm I (usual care)
1 of 2
Arm II (serum tumor directed disease monitoring)
1 of 2

Active Control

Experimental Treatment

1320 Total Participants · 2 Treatment Groups

Primary Treatment: Serum Tumor Marker directed disease monitoring · No Placebo Group · N/A

Arm II (serum tumor directed disease monitoring)Experimental Group · 3 Interventions: Serum Tumor Marker directed disease monitoring, Quality-of-Life Assessment, Anxiety Questionnaire Administration · Intervention Types: Other, Other, Other
Arm I (usual care)ActiveComparator Group · 3 Interventions: Usual care disease monitoring, Quality-of-Life Assessment, Anxiety Questionnaire Administration · Intervention Types: Other, Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 weeks after randomization

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
387 Previous Clinical Trials
261,633 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,161,866 Total Patients Enrolled
Melissa AccordinoPrincipal InvestigatorSouthwest Oncology Group

Eligibility Criteria

Age 18+ · All Participants · 21 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have breast cancer that has spread to other parts of your body, either as a new diagnosis or as a recurrence of breast cancer that had been treated earlier.

Who else is applying?

What state do they live in?
Kentucky100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Commonwealth Cancer Center-Corbin100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

How many participants are currently enrolling in this clinical research?

"Indeed, the data accessible from clinicaltrials.gov indicates that this investigation is in search of participants at present. It was first listed on July 16th 2018 and has most recently been revised on March 8th 2022. A total of 1320 patients need to be enrolled across 100 unique sites." - Anonymous Online Contributor

Unverified Answer

How many medical facilities are currently conducting this research project?

"This research project is being conducted at 100 different medical centres, which include Sewell, Orland Park and Louisville. In order to better facilitate participant involvement, it is advisable that individuals select the closest clinic location in their vicinity." - Anonymous Online Contributor

Unverified Answer

Are there remaining vacancies in this medical research endeavor?

"As per information available on clinicaltrials.gov, this medical experiment is currently recruiting individuals. The trial was first posted on July 16th 2018 and underwent its most recent update in March of 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.