View clinical trials related to Breast Neoplasms.
Filter by:This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have completed concurrent chemotherapy with pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV) and are currently receiving or will be receiving maintenance therapy with P+H IV, PH FDC SC, or trastuzumab SC in the clinic. The main objective is to enable continuity of care during the COVID-19 pandemic. This study will enroll approximately 200 patients in the United States. Participants with early or metastatic HER2+ breast cancer will be enrolled in this study. Participants with metastatic HER2+ breast cancer will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. Participants with early HER2+ breast cancer will receive PH FDC SC to complete 1 year (up to 18 cycles) of dual blockade, including the P+H IV, PH FDC SC, or trastuzumab SC they received prior to enrolling in this study, unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity, participant withdrawal of consent, or per physician's recommendation. A remote cardiac surveillance substudy will be optional for patients enrolled at select sites. The Sponsor may decide to terminate the study when the COVID-19 pandemic is no longer a risk for this patient population.
This is an expanded access program (EAP) for eligible participants designed to provide access to IMMU-132.
The purpose of this program is to provide access to tucatinib in the United States before FDA approval. Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib. All treatments will be given on a 21 day cycle. To learn more about this program, contact Seattle Genetics' Medical Information (medinfo@seagen.com).
The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
This expanded access program is an open-label, multi-center study, which will consist of a PreTreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria will be treated. The program will continue in each country until eribulin is approved, reimbursed and launched in that country, or termination of the program by the Sponsor.
This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies