PENN-Surveillance Markers for Breast Cancer Recurrence
This study is looking for women who have completed treatment for primary breast cancer within the last five years and are at higher risk for their cancer returning. The study aims to find markers in your blood and bone marrow that could predict if breast cancer will come back. You would have blood collected multiple times for biomarker analyses (looking at circulating tumor material and immune cells). The main goal is to see how often and how many disseminated tumor cells (DTCs – cancer cells that have spread from the original tumor but are not yet forming new tumors) are found over five years. If DTCs are found, you might be offered the chance to join another study testing treatments for these cells. This study is currently unclear on its recruitment status and plans to enroll 600 participants.
- Study design
- This is a single-center study that will look at 600 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would have multiple tubes of blood collected for research. You would also undergo a screening bone marrow aspirate to check for disseminated tumor cells.
- Compensation
- Not stated in the trial record.
- Follow-up
- Disseminated tumor cells will be checked annually for up to 5 years from your primary diagnosis date.
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NCT02732171
PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer
Recruiting
NAAges 18+InterventionalScreeningAbramson Cancer Center at Penn MedicineInvestigator-initiated
~600 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Research Blood Collection
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and frequency of disseminated tumor cells
Measured over DTCs will be assessed annually up to 5 years from date of primary diagnosis
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Angela DeMichele, MD · PRINCIPAL_INVESTIGATOR · Abramson Cancer Center at Penn Medicine
Who to contact
Pauleen Sanchez
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically-confirmed primary invasive breast cancer within 5 years of study entry
Qualifying risk status, at diagnosis utilizing receptor testing by ASCO/CAP guidelines, meeting at least one of the following:
Pathologically-confirmed invasive breast cancer in axillary lymph nodes, regardless of receptors
Primary tumor with triple negative subtype: estrogen receptor (ER) \< 10%, progesterone receptor (PR) \< 10% and negative Her2-overexpression by ASCO-CAP guidelines
Primary tumor that is ER+/Her2 negative/Lymph node negative with a Breast Cancer Recurrence Score of ≥ 25 per the Genomic Health Oncotype DX breast cancer test and/or HighRisk MammaPrint
Evidence of residual disease in the breast on pathologic assessment after neoadjuvant chemotherapy
Completed all primary therapy (surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry. Concurrent receipt of adjuvant endocrine therapy and bone modifying agents is allowed per standard of care. However, tamoxifen is not allowed on recurrence prevention trials that use Hydroxychloroquine. Patients on tamoxifen may still be enrolled on Penn-Surmount as long as the treating physician is aware and tamoxifen can be stopped if patient is DTC positive.
No evidence of local or distant recurrent disease by physical examination, blood tests (CBC, LFTs, Alk Phos), or symptom-directed imaging, per NCCN guidelines.
Adequate bone marrow function as shown by: ANC \>/= 1.5x10\^9/L, Platelets \>/= 100x10\^9/L, Hb \> 9 g/dL
Adequate liver function as shown by: Serum bilirubin \</= 1.5 x ULN, ALT and AST \</= 2.5 x ULN, and INR \</= 1.5
Normal coagulation studies: PT and PTT ≤ 1.5 x upper limit of normal per institutional laboratory range
Anti-coagulation is allowed if target INR \</= 1.5 on a stable dose of warfarin or on a stable dose of anticoagulant for \>2 weeks at time of enrollment. For patients on therapeutic anti-coagulants, medication must be clinically held peri-procedure (bone marrow aspirate) per standard clinical management.
Adequate renal function: serum creatinine \</= 1.5 x ULN
Willing to undergo bone marrow aspiration and blood specimen collection per protocol specifications
Age 18 or over and able to give informed consent
Exclusion
Concurrent enrollment on another investigational therapy
Patients receiving chronic, high dose systemic treatment with corticosteroids defined as: chronic use of cortisone \>50mg; hydrocortisone \>40mg, prednisone \>10mg, methylprednisone \>8mg or dexamethasone \>1.5mg; or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
EKG demonstrating QTC \> 480 ms
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
History or evidence of increased cardiovascular risk including any of the following: (i) current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation, (ii) History of acute coronary syndromes (including myocardial infarction and unstable angina, coronary angioplasty, or stenting within 6 months prior to enrollment, (iii) Current \>/= Class II congestive heart failure as defined by New York Heart Association
History of pneumonitis/interstitial lung disease or severely impaired lung function with a previously documented spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
Uncontrolled diabetes
Active (acute or chronic) or uncontrolled severe infections
Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
A known history of HIV seropositivity as reported by the patient
History of major surgical resection involving the stomach or small bowel, or pre-existing impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, Crohn's disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
Patients with an active, bleeding diathesis
History of retinopathy or retinal vein occlusion
Female patients who are pregnant or breast feeding. Women of childbearing potential must have a negative urine or serum pregnancy test.
Patients who have received prior treatment with a CDK4/6 inhibitor
Patients with a known hypersensitivity to Hydroxychloroquine or any of its derivatives
Patients with prior hydroxychloroquine exposure for a duration of \> 1 month since the completion of the patient's primary therapy (definitive surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and/or Her2-directed therapy) for the index malignancy
Patients who have initiated bone modifying agents within 3 months prior to study enrollment
A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.
What this trial measures
- Incidence and frequency of disseminated tumor cellsDTCs will be assessed annually up to 5 years from date of primary diagnosis
Bone marrow sample is evaluated for DTCs by a standard immunohistochemistry assay (DTC-IHC)