PENN-Surveillance Markers of Utility for Recurrence After (Neo)Adjuvant Therapy for Breast Cancer
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).
• 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