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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

Must not have

History of pneumonitis/interstitial lung disease or severely impaired lung function

Uncontrolled diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up dtcs will be assessed annually up to 5 years from date of primary diagnosis

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My cancer has not returned after treatment.

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I am 18 years or older and can legally consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had lung inflammation or severe lung problems.

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My diabetes is not under control.

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I do not have any severe infections that are currently active or uncontrolled.

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I have tested positive for HIV.

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I have a history of heart problems or am at high risk for them.

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I have a chronic liver condition.

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I have a condition that causes me to bleed easily.

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I have had retinopathy or a blockage in my retina's blood vessels.

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I am not pregnant or breastfeeding.

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I have been treated with a CDK4/6 inhibitor before.

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I am on long-term, high dose steroid medication.

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I have had major surgery on my stomach or small bowel, or I have a pre-existing stomach or bowel condition.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and dtcs will be assessed annually up to 5 years from date of primary diagnosis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and frequency of disseminated tumor cells

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: 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.

0 / 14Eligibility criteria met