Is NCT02732171 recruiting in Philadelphia, PA?

Yes, NCT02732171 is currently recruiting participants at its Philadelphia, PA location. This breast cancer clinical trial is actively enrolling qualified participants.

How do I join the breast cancer clinical trial in Philadelphia?

To join this clinical trial in Philadelphia, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Philadelphia clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Breast Cancer Clinical Trial in Philadelphia, PA

About This Breast Cancer Study in Philadelphia

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).

Sponsor: Abramson Cancer Center at Penn Medicine

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT02732171) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Breast Cancer Treatment Options in Philadelphia, PA

If you're searching for breast cancer treatment options in Philadelphia, PA, this clinical trial (NCT02732171) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all breast cancer clinical trials near you to find additional studies recruiting in your area.

Breast Cancer Clinical Trial in Philadelphia, PA

Expert Care in Philadelphia

IRB Approved

No-Cost Care

Apply for This Philadelphia Location

Why Participate?

Simple Process