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Participants with TNBC (triple negative breast cancer) for Breast Cancer

N/A
Recruiting
Led By Kamran A Ahmed, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
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 up to 6 months
Awards & highlights

Summary

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of Brain Metastasis
Secondary study objectives
Brain Metastasis Specific Survival
Number of Brain Metastases
Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation
+2 more

Side effects data

From 2022 Phase 3 trial • 53 Patients • NCT00033293
19%
87900-Vomiting(targeted toxicity)
15%
11400-Agitation
8%
58700-Nystagmus
8%
16800-Bladder infection
8%
11600-Alanine aminotransferase increased
8%
44800-Infections and infestations - Other specify
4%
58300-Neutrophil count decreased
4%
41400-Hyperglycemia(targeted toxicity)
4%
69700-Rash maculo-papular(targeted toxicity)
4%
33900-Fever
4%
33300-Febrile neutropenia
4%
20500-Catheter related infection
4%
42600-Hypoalbuminemia
4%
43100-Hypokalemia
4%
88500-White blood cell decreased
4%
41300-Hypercalcemia
4%
42700-Hypocalcemia
4%
15300-Ataxia
4%
64400-Personality change
4%
13200-Anemia
4%
57600-Nausea(targeted toxicity)
4%
13500-Anorexia
4%
15000-Aspartate aminotransferase increased
4%
25700-Diarrhea
4%
41600-Hyperkalemia
4%
41500-Hyperhidrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Chemotherapy, Immunoglobulin Therapy)
Arm II (Chemotherapy, Observation)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Participants with TNBC (triple negative breast cancer)Experimental Treatment1 Intervention
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
Group II: Participants with Human Epidermal Growth Factor Receptor 2 (HER2) + Breast CancerExperimental Treatment1 Intervention
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
Group III: Participants with Hormone Receptor (HR) +Breast CancerExperimental Treatment1 Intervention
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

Florida Breast Cancer FoundationUNKNOWN
2 Previous Clinical Trials
67 Total Patients Enrolled
1 Trials studying Breast Cancer
27 Patients Enrolled for Breast Cancer
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
558 Previous Clinical Trials
144,440 Total Patients Enrolled
42 Trials studying Breast Cancer
5,796 Patients Enrolled for Breast Cancer
Kamran A Ahmed, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
31 Total Patients Enrolled
~8 spots leftby Jan 2025
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