NCT04250818

Brief Summary

Recent progress in immunotherapy (IT) has shifted treatment paradigms for multiple malignancies including breast cancer. It has been shown that levels of certain cytokines were correlated with increased response to immunotherapy in patients with metastatic breast cancer. In this study investigators will perform cytokine profiling among patients diagnosed with metastatic triple-negative breast cancer at different time points during the treatment.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
suspended

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

July 2, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

December 18, 2019

Last Update Submit

May 17, 2021

Conditions

Metastatic Triple-Negative Breast Cancer

Keywords

cytokine, breast cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    12 months

Study Arms (2)

Control Group

Patients with mTNBC who receive chemotherapy only

Experimental Group

patients with mTNBC who receive a combination of chemotherapy and Immunotherapy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe majority of the patients with triple negative breast cancer are women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women diagnosed with triple negative breast cancer

You may qualify if:

  • Diagnosis of metastatic triple negative breast cancer
  • years of age or older

You may not qualify if:

  • Younger than 18
  • Unwilling to participate or unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University HSC El Paso

El Paso, Texas, 79905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and whole blood cells

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 18, 2019

First Posted

January 31, 2020

Study Start

July 2, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

May 19, 2021

Record last verified: 2021-05

Locations

US(1)