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Bone marrow tests may spot breast Cancer's hidden seeds

NCT ID NCT02732171

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Apr 2016

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Abramson Cancer Center of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

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