Physician

Neil Belman, DO

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

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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
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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This study is being done to compare the usual treatment alone to the usual treatment plus Herceptin Hylecta or PHESGO. The addition of trastuzumab / Herceptin Hylecta or trastuzumab / pertuzumab / PHESGO to the usual treatment could prevent your cancer from returning or shrink your cancer. This study will help the study doctors find out if the different approach is better, the same or worse than the usual approach. The usual approach is chemotherapy with two agents called paclitaxel and carboplatin.

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Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

• Treatment naïve (not previously treated) stage IA-IVB endometrial serous carcinoma or endometrial carcinosarcoma
• All patients must have tumors that are HER2 positive (ex. 3+ by IHC, 2+ by ISH)
• Patients may have measurable disease, non-measurable disease, or no measurable disease on CT or MRI imaging
• For patients with uterine-confined (stage I) disease, the tumor must be invasive into the myometrium
• Patients may not have received prior chemotherapy, biologic therapy, or targeted therapy for treatment of endometrial carcinoma
• Patients may not have received prior radiation therapy for treatment of endometrial carcinoma
• Vaginal brachytherapy for treatment of endometrial cancer is permitted during study treatment but must be determined at time of study registration

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