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CT Scan for Breast Cancer
Tampa, FL
Phase 2
Recruiting
Led By Kamran Ahmed
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
Node positive HER2+ and triple negative breast cancer (ypN+) following neoadjuvant chemotherapy
Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
Must not have
Prior diagnosis of systemic metastases
Chronic kidney disease stage IV or V or end stage renal disease (CrCl <30 ml/min)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find out how often breast cancer spreads to other parts of the body after chemotherapy and surgery. Participants will be monitored for about 6 months and will have CT scans of their chest,
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Who is the study for?
This trial is for individuals with breast cancer who have positive lymph nodes after chemotherapy and surgery. They must be scheduled for adjuvant radiation therapy and willing to undergo CT scans of the thorax, abdomen, and pelvis at the start of the study and again at 6 months if initial scans are negative.Check my eligibility
What is being tested?
The study aims to find out how often systemic metastasis occurs in node-positive breast cancer patients by using CT scans before and after adjuvant radiation therapy over a period of about 6 months.See study design
What are the potential side effects?
CT scans are generally safe but may include exposure to low levels of radiation which carries a very small risk of potential long-term effects such as cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is HER2+ or triple negative and spread to lymph nodes after initial chemo.
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Select...
My breast cancer's ER/PR/HER2 status is documented.
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Select...
My breast cancer is hormone receptor positive, HER2 positive, or triple negative.
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Select...
My breast cancer is HR+ /HER2- and was classified as stage ypN2 or ypN3 after initial treatment.
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Select...
I've completed at least 8 weeks of initial chemo for HER2+ cancer.
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I can perform daily activities with little to no assistance.
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I am 18 years old or older.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to other parts of my body.
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Select...
My kidney function is very low (stage IV, V, or end-stage).
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Systemic Metastasis
Secondary study objectives
Metastasis Frequency
Metastasis Treatment
Side effects data
From 2017 Phase 2 trial • 14 Patients • NCT0143748864%
Fatigue
43%
Diarrhea
36%
Constipation
36%
Anemia
36%
Nausea
21%
Creatinine Increased
21%
Lightheadedness
21%
Vomiting
21%
Hypokalemia
14%
Abdominal Pain
14%
Back Pain
14%
Dizziness
14%
Fever
14%
Flu-Like symptoms
14%
Hypomagnesia
14%
Pinching sensation around port
14%
Shortness of Breath
14%
URI
14%
Abdominal cramping
14%
Insomnia
14%
Thrombocytopenia
7%
Tearing
7%
Pulmonary Embolism
7%
Sacral Edema
7%
Tinnitus
7%
Embolic stroke
7%
Bloating
7%
PTT prolonged
7%
Acid Reflux
7%
Blood in Bilirubin increased
7%
Decreased Appetite
7%
Dry Skin
7%
INR increased
7%
Pyelonephritis
7%
Rash
7%
Anorexia
7%
Anxiety
7%
Dyspnea
7%
Dysuria
7%
Fall
7%
Flatulence
7%
Foot Pain
7%
Hematoma
7%
Leg pain
7%
Loose Stools
7%
mild-mod Congestion
7%
Neutrophil count decreased
7%
Neuropathy
7%
Rib pain
7%
Throat discomfort
7%
Urinary incontinence
7%
Urinary Tract Obstruction
7%
Worsening pain
7%
Vision changes
7%
Hypoxia
7%
Abdominal distention
7%
Alkalosis
7%
Bladder Spasm
7%
Blurred Vision
7%
Bone Pain
7%
Cabazitaxel Infusion reaction
7%
Change in Taste
7%
Epigastric Pain
7%
Hematuria
7%
Hypophosphatemia
7%
Hypertension
7%
Pain in Pelvis
7%
Paresthesia bilateral feet
7%
Perioral numbness
7%
Peripheral Neuropathy
7%
Weakness
7%
Weight loss
7%
Tachycardia
7%
Bleeding Gums
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabazitaxel
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Triple negativeExperimental Treatment1 Intervention
Participants diagnosed with triple negative breast cancer.
Group II: Hormone receptor (HR)+Experimental Treatment1 Intervention
Participants diagnosed with hormone receptor (HR)+ breast cancer.
Group III: HER2+Experimental Treatment1 Intervention
Participants diagnosed with HER2+ breast cancer.
Find a Location
Closest Location:Moffitt Cancer Center· Tampa, FL· 1119 miles
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
575 Previous Clinical Trials
144,905 Total Patients Enrolled
41 Trials studying Breast Cancer
4,096 Patients Enrolled for Breast Cancer
Florida Breast Cancer FoundationOTHER
3 Previous Clinical Trials
185 Total Patients Enrolled
1 Trials studying Breast Cancer
27 Patients Enrolled for Breast Cancer
Kamran AhmedPrincipal InvestigatorMoffitt Cancer Center
Matthew MillsPrincipal InvestigatorMoffitt Cancer Center