Actively Recruiting
PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer
Led by Abramson Cancer Center at Penn Medicine · Updated on 2025-08-01
600
Participants Needed
1
Research Sites
730 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single center, prospective cross-sectional study of women who have completed therapy for primary breast cancer within 5 years of diagnosis and are at increased risk for relapse. Patients will undergo screening bone marrow aspirate to test for presence of disseminated tumor cells (DTCs) Patients who harbor DTCs will be offered the opportunity for enrollment into a clinical trial of therapy targeting DTCs to prevent recurrence (separate protocols).
CONDITIONS
Official Title
PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically-confirmed primary invasive breast cancer within 5 years of study entry
- Qualifying risk status at diagnosis using receptor testing by ASCO/CAP guidelines, including:
- Pathologically-confirmed invasive breast cancer in axillary lymph nodes
- Primary tumor with triple negative subtype: estrogen receptor < 10%, progesterone receptor < 10%, and negative Her2-overexpression
- Primary tumor that is ER+/Her2 negative/Lymph node negative with Breast Cancer Recurrence Score ≥ 25 or HighRisk MammaPrint
- Evidence of residual disease in the breast after neoadjuvant chemotherapy
- Completed all primary therapy for the index malignancy at least 4 weeks before study entry
- Concurrent adjuvant endocrine therapy and bone modifying agents allowed, except tamoxifen on some recurrence prevention trials
- No evidence of local or distant recurrent disease by physical exam, blood tests, or imaging
- Adequate bone marrow, liver, coagulation, and renal function per specified laboratory values
- Anti-coagulation allowed if stable and managed peri-procedure
- Willingness to undergo bone marrow aspiration and blood collection
- Age 18 or older and able to give informed consent
You will not qualify if you...
- Concurrent enrollment in another investigational therapy
- Chronic high-dose systemic corticosteroid use above specified doses
- EKG showing QTC > 480 ms
- Severe or uncontrolled medical conditions affecting study participation, including:
- Uncontrolled arrhythmias (except controlled atrial fibrillation)
- Recent acute coronary syndromes or interventions within 6 months
- Class II or higher congestive heart failure
- History of pneumonitis/interstitial lung disease or severely impaired lung function
- Uncontrolled diabetes
- Active or uncontrolled severe infections
- Liver disease such as cirrhosis or chronic hepatitis
- Known HIV infection
- Major gastrointestinal surgery or significant gastrointestinal disease
- Active bleeding disorders
- History of retinopathy or retinal vein occlusion
- Pregnant or breastfeeding women; women of childbearing potential must have negative pregnancy test
- Prior treatment with CDK4/6 inhibitors
- Known hypersensitivity to Hydroxychloroquine or derivatives
- Prior hydroxychloroquine use over 1 month since completion of primary therapy
- Initiation of bone modifying agents within 3 months prior to enrollment
- Positive Hepatitis B/C history requiring screening and testing per protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
P
Pauleen Sanchez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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