Breast Cancer Clinical Trials in Baltimore, MD

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers. Read Less

This is a first-in-human phase I/II study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers. Read Less

The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available. The secondary objectives are to characterize the PK of LP-184 and its metabolites in plasma and assess clinical activity of LP-184. Participants will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, PK, and clinical activity Read Less

The goal of this research study is to determine if the investigators can predict which participants will respond to endocrine therapy and a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor for metastatic breast cancer and which participants will not. Investigators will use information from the tumor tissue and serial blood samples. Investigators hope that a deeper understanding of which participants will respond to this combination and how resistance emerges will allow the investigators to better tailor therapies for metastatic breast cancer. Subjects will have archived tissue or new biopsy collected at study enrollment. This tissue will undergo special molecular testing. Subjects will also have blood collected at study enrollment and periodically thereafter. This blood will also undergo special molecular testing. Information from this testing will not be available to subjects or their treating physicians as the investigators do not know how this information should impact treatment. The investigators will collect information about which treatment the subjects receive and how their cancer responds. Any man or woman being seen at Johns Hopkins for treatment of newly diagnosed estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) metastatic breast cancer may be eligible. Read Less

The key hypothesis for this study is that collection of the PRO surveys via the Outcomes4Me app is feasible, as measured by survey completion rates. In addition to informing feasibility, this study will provide information about symptom trajectories, symptom management interventions, and early endocrine therapy adherence and persistence. Patients with risk factors for adjuvant endocrine therapy non-adherence or early discontinuation will complete patient-reported outcome (PRO) surveys via smart phone app at baseline and 2, 4, 8 and 12 weeks after adjuvant endocrine therapy initiation. Since symptoms and side effects are a key driver of adjuvant endocrine therapy non-adherence and non-persistence, the investigators anticipate that enhanced detection of symptoms via use of PRO surveys will result in improved symptom management and, could thereby support treatment adherence and persistence. This pilot study will assess the feasibility of the PRO survey intervention. In this pilot study, feedback about the intervention will be obtained from patients and from members of the study teams and clinical teams caring for the patients who participate. Read Less

The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months. Read Less

This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy. Read Less

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Read Less

Traditional clinical trials in patients with breast cancer leptomeningeal disease (LMD) are challenging as patients often have a rapidly progressive course and prognosis is poor, making meeting standard eligibility difficult. Furthermore, there is limited information about the biology of LMD. The investigators thus propose a study that is as inclusive as possible, which will allow the investigators to collect biospecimens and clinical outcomes to learn more about LMD biology, but still potentially provide benefit for patients, by providing patients rapid diagnostics and multi-disciplinary treatment recommendations. Read Less

The GammaPod machine was made by Xcision Medical Systems and is already FDA cleared to deliver focused radiation within the breast. Unlike current radiation machines, the GammaPod was designed specifically for treating breast cancer. The GammaPod can pinpoint radiation to the tumor bed in the breast which lowers the amount of radiation to nearby tissues. The machine uses a breast cup system to hold the breast in place for the treatment. This breast cup system was tested at MSGCCC (Marlene Stewart Greenebaum Comprehensive Cancer Center). Patients reported this system was more comfortable than an MRI or mammogram. The cup system was able to securely position the breast for treatment in the correct location. Receiving radiation before surgery is not a new concept in cancer management. Preoperative radiation has proven to result in improved disease free survival in certain types of cancer. With this study treatment, the participants will receive a dose of breast radiation therapy before the lumpectomy surgery. The lumpectomy surgery is where they remove the participant's tumor. The purpose of this research study is to determine a safe and effective dose of pre-operative radiation to treat early stage breast cancer. The pre-operative radiation is delivered using the FDA approved, GammaPod machine. The study will also determine the cosmesis of pre-operative radiation at different doses. Cosmesis is another word for looking at skin changes. The research team will use questionnaires for patient and physicians to assess adverse cosmesis changes as accurately as possible. In addition, the investigators are going to assess radiation related changes using photo software analysis tools and patients quality of life. Read Less

Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4 cycles of neoadjuvant paclitaxel/carboplatin/pembrolizumab. A PET scan will be performed at baseline and after 1 cycle of therapy. A breast MRI will be performed after treatment completion. Patients with complete clinical response will proceed to surgery. Patients with clinical residual disease will complete neoadjuvant rescue with 4 cycles of doxorubicin/cyclophosphamide prior to surgery. If residual disease identified after surgery, adjuvant therapy to be determined by the treating oncologist (may include doxorubicin/cyclophosphamide/pembrolizumab, capecitabine etc). Read Less

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened. Read Less