Breast Cancer Clinical Trials in Houston, TX

This is a phase 1/2, open-label, multi-center, first-in-human, two-stage (Part 1: dose escalation and Part 2: dose expansion) study evaluating multiple doses and schedules of intravenously (IV) administered HMBD-002, with or without pembrolizumab, in patients with advanced solid tumors (i.e., locally advanced and unresectable, or metastatic). Read Less

The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed. Read Less

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Read Less

This will be a Phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors with or without brain metastases. The study will consist of three phases: Phase 1a (dose escalation with ZN-A-1041 monotherapy), Phase 1b (dose escalation with ZN-A-1041 combination therapy) and Phase 1c (dose expansion with ZN-A-1041 combination therapy). Read Less

The purpose of this study is to determine how well participants with stage II-III HER2-positive breast cancer respond to pre-operative treatment using one of two different combinations of drugs. Drugs and Combinations used: Paclitaxel, Pertzumab and Margetuximab (Margenza) Paclitaxel, Pertzumab and Trastuzumab (Herceptin) Read Less

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab Learn more about the side effects of BT5528 Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. Learn more about BT5528 therapy alone and in combination with nivolumab. Read Less

Cancer survivors have unique healthcare needs including risk for serious late effects, ongoing surveillance, lifestyle modifications to reduce second cancer risk, and psychosocial support. Nearly 70% have at least one comorbid chronic condition in addition to cancer. Comorbidities pose significant challenges to the delivery of quality cancer care because they adversely affect and are affected by cancer treatment. Medically underserved patients have the highest burden of multiple chronic conditions and are at increased risk for poor outcomes during and after cancer treatment. As medically underserved cancer patients may lack healthcare knowledge and access to supportive care, their health outcomes and care transitions might be improved by enhancing communication and collaboration between their oncologists and primary care providers (PCPs). This study tests and evaluates a novel shared care model for cancer survivors with chronic comorbidities, called OPTIMISE (Oncology-Primary Care Partnership to Improve Comprehensive Survivorship Care) in the largest safety-net healthcare system in Houston, Texas. Three-hundred newly diagnosed breast, GI, and hematological cancer patients who are being treated with curative intent and who have comorbidities requiring ongoing management during cancer treatment will complete baseline surveys and be randomized to either OPTIMISE or Usual Medical Care (UMC). Patients receiving UMC will receive their cancer treatment, as directed by their oncologist, a survivorship care plan (SCP) at the end of active treatment, and surveillance visits with their oncologist based on national guidelines. Patients in OPTIMISE will 1) have an oncology nurse navigator assigned to their care team at diagnosis to facilitate oncologist-PCP communication and continuity of care; 2) receive coordinated care between their oncologist and PCP throughout cancer treatment and surveillance facilitated by a structured communication and referral process; 3) receive a survivorship care plan (SCP) at the end of treatment that incorporates comorbidity management; and, 4) receive a risk-stratified shared care model of post-treatment surveillance where one or more routine oncologist follow-up visits is replaced by a PCP visit. Aim 1a evaluates the impact of OPTIMISE on patient chronic disease self-management (primary outcome) and quality of life (secondary outcome). Aim 1b explores the effects of OPTIMISE on healthcare use and patient unmet needs during and after active cancer treatment. Aim 2 examines the effects of OPTIMISE on oncologist and PCP attitudes and coordination of care. Aim 3 seeks to elucidate patient- and system-level factors that may influence implementation outcomes. OPTIMISE shifts the timing of thinking about survivorship to point of diagnosis and seeks to develop a clinical infrastructure to support continuity of care from cancer diagnosis through post-treatment survivorship. If found effective, OPTIMISE could be expanded to other cancers, igniting a potentially rich area of research. It may also have significant downstream impact in other medical settings by enhancing care transitions from specialty to primary care. Read Less

This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer. Read Less

This is a phase 1, multicenter, open-label, first-in-human study of YL202 conducted in the United States and China. The study will evaluate the safety and tolerability of YL202 in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC or hormone receptor (HR)-positive and HER2-negative BC, which have been heavily treated by standard treatment. Read Less

This phase IIb trial studies the combined effect of prolonged nightly fasting and metformin hydrochloride extended release in decreasing breast tumor cell proliferation and other biomarkers of breast cancer. Preventing invasive breast cancer or DCIS. Metformin is widely used to treat type II diabetes and is associated with a decreased risk of cancer and death in diabetic individuals. Intermittent fasting may protect cancer patients from the toxic effects of chemotherapy agents without causing chronic weight loss. The combination of intermittent fasting and metformin may reduce breast cancer growth and may be used in women at risk for breast cancer or other cancers associated with being overweight. Read Less

This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study. The primary purpose of the parts are: Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors This study is expected to last approximately 6 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: they withdraw their disease gets worse they experience unacceptable side effects. The primary purpose of the sub-study is to compare the effectiveness of steroid versus non-steroid mouthwash as prophylaxis against oral mucositis/stomatitis in participants receiving DS-1062a. The sub-study is a randomized study that will include approximately 76 participants enrolling into the Dose Expansion part. Read Less

To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers. Read Less