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Arm 1: Advanced ER-positive and HER2-negative Breast Cancer for Breast Cancer

N/A
Recruiting
Research Sponsored by BioCorteX Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, week 2, week 4, week 6
Awards & highlights

Study Summary

The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer to see how the bacteria in the body affect cancer and how well it responds to treatment. By comparing samples and data from multiple participants with breast cancer, it may be possible to identify how a person's gut health and tumor microenvironment affects how they respond to certain cancer treatments.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, week 2, week 4, week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, week 2, week 4, week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interaction between the gut microbiome, tumor microbiome and serum immune profile for patients with early stage (II-III), locally advanced or advanced ER-positive and HER2-negative breast cancer.

Side effects data

From 2016 Phase 3 trial • 356 Patients • NCT00048997
31%
Fatigue (lethargy, malaise, asthenia)
23%
Alopecia
17%
Late RT Toxicity: Other: NOS
11%
Nausea
10%
Anorexia
9%
Late RT Toxicity: Brain: NOS
9%
Headache
7%
Late RT Toxicity: Skin: NOS
6%
Memory loss
1%
Dyspnea (shortness of breath)
1%
Mood alteration-depression
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1: Advanced ER-positive and HER2-negative Breast CancerExperimental Treatment1 Intervention
Advanced ER+ and HER2- breast cancer participants due to receive standard of care CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) in combination with endocrine therapy.

Find a Location

Who is running the clinical trial?

Tempus LabsIndustry Sponsor
16 Previous Clinical Trials
18,015 Total Patients Enrolled
1 Trials studying Breast Cancer
1,000 Patients Enrolled for Breast Cancer
Tempus AIIndustry Sponsor
16 Previous Clinical Trials
17,515 Total Patients Enrolled
1 Trials studying Breast Cancer
1,000 Patients Enrolled for Breast Cancer
BioCorteX IncLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
2023. "Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06126003.
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~14 spots leftby Dec 2024
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