Bone marrow tests may spot breast Cancer's hidden seeds
NCT ID NCT02732171
First seen Jul 27, 2026 · Last updated Aug 20, 2026 · Updated 3 times
Summary
This study looks at whether testing bone marrow for hidden cancer cells can help predict breast cancer recurrence in women who have completed treatment within the past five years. Researchers will collect blood and bone marrow samples from 600 women at increased risk of relapse. The goal is to see if these 'disseminated tumor cells' are linked to future recurrence, which could lead to earlier detection and prevention strategies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this approach could help identify women at high risk of breast cancer recurrence and guide early treatment to prevent relapse.
- What could go wrong
- This is an early-stage observational study, not a treatment trial. The bone marrow test may not reliably predict recurrence, and even if it does, it is unclear whether targeting those cells will improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Apr 2016
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Abramson Cancer Center of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Email: •••••@•••••
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