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Metastatic Breast Cancer patients for Breast Cancer

N/A
Waitlist Available
Led By Ana Lohmann, MD, PhD
Research Sponsored by Lawson Health 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 its a single visit study and study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
Awards & highlights
No Placebo-Only Group

Summary

Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. It may also provide information on tumor markers (hormone receptors, HER2) that can guide treatment decisions. The goal of this study is to determine whether blood tests (which require less-invasive procedures) can be used to confirm diagnosis of suspected recurrent breast cancer (as compared to tissue biopsy). Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood), circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood), as well as other biomarkers. Investigators will conduct this study in 120 participants who present with suspected breast cancer recurrence and symptoms of cancer that has spread to other areas in the body. Participants will be asked for blood collection within 30 days before tissue biopsy. The tissue will be analysed locally to determine the presence of cancer and the tumor markers listed above. The blood will be processed and stored for analysis of CTCs and ctDNA. If these blood tests show concordance with tissue based tests (presence of cancer cells, hormone receptors \& HER2 status), these tests could be used in future studies to confirm diagnosis using a non-invasive procedure. Also, investigators believe that the results of this study can influence other research of early-stage recurrent breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~its a single visit study and the study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and its a single visit study and the study investigators try to have a blood draw from patients within 30 days prior to tissue biopsy. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concordance between liquid and tissue biopsy in terms of presence or absence of Cancer
Secondary study objectives
Classification of tissue biopsy results
Concordance between liquid and tissue biopsy in terms of hormone and HER2 status
Exploratory analysis

Side effects data

From 2017 Phase 2 trial • 14 Patients • NCT01437488
64%
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%
Tinnitus
7%
Bloating
7%
Blood in Bilirubin increased
7%
Decreased Appetite
7%
Dry Skin
7%
Sacral Edema
7%
Acid Reflux
7%
INR increased
7%
Embolic stroke
7%
Pulmonary Embolism
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
7%
PTT prolonged
7%
Pyelonephritis
7%
Rash
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

1Treatment groups
Experimental Treatment
Group I: Metastatic Breast Cancer patientsExperimental Treatment1 Intervention
Investigators plan to enroll patients who are undergoing biopsy for potential metastatic Breast Cancer any subtype ER/PgR+ and HER2, triple negative or HER2+ at least 6 months before suspected metastases were identified. The suspected metastases in these patients must be outside the ipsilateral breast, axilla infra/supraclavicular areas. In those with suspected metastases in contralateral axilla, infra/supraclavicular areas only a new contralateral breast primary must be excluded by physical exam, mammogram and MRI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Draw
2014
Completed Phase 4
~2350

Find a Location

Who is running the clinical trial?

Epic SciencesIndustry Sponsor
6 Previous Clinical Trials
6,541 Total Patients Enrolled
2 Trials studying Breast Cancer
647 Patients Enrolled for Breast Cancer
Lawson Health Research InstituteLead Sponsor
676 Previous Clinical Trials
416,523 Total Patients Enrolled
7 Trials studying Breast Cancer
260 Patients Enrolled for Breast Cancer
Toronto Sunnybrook Regional Cancer CentreOTHER
9 Previous Clinical Trials
833 Total Patients Enrolled
2 Trials studying Breast Cancer
54 Patients Enrolled for Breast Cancer
~23 spots leftby Oct 2025