Physician

Lee Riley, MD

Study Coordinator

Helen McGunnigle
484-658-5044
Helen.McGunnigle@sluhn.org

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Treatment Agent: N/A

Synopsis: You have been asked to consider taking part in this registry because you are being treated for stage I, stage II,or stage III breast cancer. If you participate, your doctor will receive the results of the Agendia Breast Cancer Suite (MammaPrint and BluePrint). 

The purpose of this registry is to create a large-scale, population-based database. This database will match health information to genome information to look at the Agendia Breast Cancer suite and new gene associations. The Agendia Breast Cancer Suite includes MammaPrint® and BluePrint™, which are tests that help your doctor analyze and profile your breast cancer tumor. DiscoverPrint is for research purposes only and the results will not be made available for use in your current breast cancer management.

• MammaPrint, an FDA cleared test, is used clinically to determine your risk for distant metastasis.
• BluePrint provides physicians with more information about their patient’s unique tumor biology.
• DiscoverPrint will allow the study of new gene associations and additional biomarkers that may be found to be relevant to breast cancer therapy and diagnosis.
• Breast cancer with different biological properties may respond different to certain therapies.

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• Is ≥18 years of age, at the time of signing the informed consent
• Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female) - New primary lesion - Eligible for chemo and endocrine therapy

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Physician

Neil Belman, DO

Study Coordinator

Angela Rankin
484-658-1792
Angela.Rankin@sluhn.org

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This is a Phase 2 study evaluating the efficacy of a CDK, PI3K, or NTRK/ROS1 inhibitor in patients with progressive brain metastases from solid tumors harboring the alterations predicting sensitivity to each of these inhibitors.

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• Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor

• Tissue must be available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If extracranial tissue is not available or there is no evidence of extracrania disease, brain metastasis tissue is sufficient for eligibility

• Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy

• Patients must be able to undergo MRI with contrast

• Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review

• For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting

• For TNBC, patients must have had at least one chemotherpy in the metastatic setting

• For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting

• For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease

• For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease

• No known current diffuse leptomeningeal involvement

• No surgery within 2 weeks prior to or after registration

• No chemotherapy within 14 days prior to registration

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Physician

Nicholas Taylor, MD

Study Coordinator

Janine Schippang
484-658-1790
JanineL.Schippang@sluhn.org

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A Phase 3 Radomized Placebo Controlled Double Blind Study of Romiplostim for the treatment of Chemotherapy- induced Thrombocytopenia in Patients receiving chemotherapy for treatment Non-small cell lung cancer (NSCLC), Ovarian Cancer, or Breast cancer.

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• Is ≥18 years of age, at the time of signing the informed consent
• Stage I, II, III, or IV locally advanced NSCLC, Breast cancer, or ovarian cancer or any stage recurrent disease.
• Patients must have platelet count less than 85 x 10^9/L on day 1 of the study
• Patients must be receiving cancer treatment with 21 – or 28- day cycles using one of the following carboplatin- based combination chemotherapy regimens: carboplatin/ gemcitabine based, carboplatin/ premextred based, carboplatin/ liposomal doxorubicin based, or carboplatin/ taxane based (which includes either paclitaxel, nab- paclitaxel, or docetaxel)
• Patients must have at least 3 remaining planned cycles of chemotherapy at study enrollment
• No previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor, eltromobag, recombinant human TPO, any other TPO receptor antagonist, or any investigational platelet producing agent

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Physician

Eleanor Harris, MD

Study Coordinator

Helen McGunnigle
484-658-5044
Helen.McGunnigle@sluhn.org

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This study is being conducted to evaluate whether treatment with surgery and hormonal therapy for low-risk Stage I hormone sensitive, HER2-negative, breast cancer is as good as the usual treatment of surgery, radiation and hormonal therapy. In this study all participants must will take hormonal therapy for 5 years, some will receive radiation therapy in addition to the hormonal therapy.

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• Stage I, pT1N0M0 (≤ 2cm), HER2-negative, ER and/or PgR- positive breast cancer
• Unilateral invasive adenocarcinoma of the breast on histologic examination
• Patients must have undergone a lumpectomy and the margins must be histologically free of invasive tumor and DCIS (mastectomy is not allowed)
• Oncotype-DX recurrence score ≤ 18
• Patients with a T1a tumor (≤ 0.5 cm) do not have an Oncotype DX recurrence score previously documented, a tissue sample will be sent to the central lab for results prior to randomization
• Interval between last surgery for breast cancer and study entry must be no more than 70 days
• Bilateral mammogram or MRI required within 6 months prior to study entry
• Patients must be intending to take endocrine therapy for a minimum of 5 years (tamoxifen or AI), but CANNOT start endocrine therapy until AFTER enrollment on study

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