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Biomarker Monitoring for Breast Cancer Recurrence Risk
N/A
Recruiting
Led By Angela DeMichele, MD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of local or distant recurrent disease
Age 18 or over and able to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dtcs will be assessed annually up to 5 years from date of primary diagnosis
Awards & highlights
Study Summary
This trial is for women who have completed therapy for breast cancer within 5 years of diagnosis and are at increased risk for relapse. Patients will have a bone marrow aspirate to test for presence of disseminated tumor cells (DTCs). If they have DTCs, they will be offered enrollment into a clinical trial of therapy targeting DTCs to prevent recurrence.
Who is the study for?
This trial is for women who finished breast cancer treatment within the last 5 years, have no signs of recurrence, and are at high risk of relapse. They must be willing to undergo bone marrow aspiration and blood tests, meet specific receptor criteria, and have good organ function. It's not for those with severe health issues, on other trials or certain medications, with cardiovascular risks or a history of lung disease.Check my eligibility
What is being tested?
The study involves collecting blood samples from participants to check for disseminated tumor cells (DTCs) in the bone marrow. Women found to have DTCs may join further trials targeting these cells to prevent cancer recurrence.See study design
What are the potential side effects?
Since this trial primarily involves research blood collection and bone marrow aspirate testing rather than drug interventions, side effects are minimal but may include discomfort or bruising at the needle site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not returned after treatment.
Select...
I am 18 years or older and can legally consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ dtcs will be assessed annually up to 5 years from date of primary diagnosis
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dtcs will be assessed annually up to 5 years from date of primary diagnosis
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and frequency of disseminated tumor cells
Trial Design
1Treatment groups
Experimental Treatment
Group I: Screening Bone Marrow AspirateExperimental Treatment1 Intervention
All patients will undergo screening bone marrow aspirate to test for disseminated tumor cells (DTCs) by immunohistochemistry. The bone marrow sample is also used for other research tests.
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,095 Total Patients Enrolled
44 Trials studying Breast Cancer
60,249 Patients Enrolled for Breast Cancer
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
104,495 Total Patients Enrolled
41 Trials studying Breast Cancer
34,733 Patients Enrolled for Breast Cancer
Angela DeMichele, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
8 Previous Clinical Trials
10,592 Total Patients Enrolled
6 Trials studying Breast Cancer
9,938 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung inflammation or severe lung problems.My diabetes is not under control.I do not have any severe infections that are currently active or uncontrolled.I have tested positive for HIV.My hepatitis B/C history and risk factors have been reviewed.I was diagnosed with invasive breast cancer in the last 5 years.Your EKG shows that your heart's QTC is longer than 480 milliseconds.I have a history of heart problems or am at high risk for them.I have a chronic liver condition.I have a condition that causes me to bleed easily.I have had retinopathy or a blockage in my retina's blood vessels.I am not pregnant or breastfeeding.I have been treated with a CDK4/6 inhibitor before.You are allergic to hydroxychloroquine or any similar medications.I am on long-term, high dose steroid medication.I have had major surgery on my stomach or small bowel, or I have a pre-existing stomach or bowel condition.I have taken hydroxychloroquine for more than a month after my main treatment.I started taking medication for bone health within the last 3 months.I finished my main cancer treatment at least 4 weeks ago.My cancer has not returned after treatment.My blood, liver, and kidney tests are within normal ranges.I am willing to have bone marrow and blood tests as required.My cancer meets specific risk criteria based on receptor tests.I am 18 years or older and can legally consent.
Research Study Groups:
This trial has the following groups:- Group 1: Screening Bone Marrow Aspirate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are engaging in this clinical trial?
"Indeed, the information on clinicaltrials.gov affirms that this research is currently recruiting participants. This experiment was initially posted in April 2016 and latest updated September 2022. 600 patients need to be recruited from a single medical centre for this study to progress forward."
Answered by AI
Is enrollment for this trial still open to participants?
"Affirmative. Clinicaltrials.gov has published evidence indicating this medical research project is at present recruiting participants - the original posting was dated April 1st, 2016, and it was most recently updated on September 9th 2022. This clinical trial necessitates 600 patients from one site to participate in the study."
Answered by AI
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