Clinical Research Directory

Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...

Background: \- Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer cells. This study has two components. In the phase 1 component of the study, researchers want to investigate how well participants tolerate the combination of these drugs in treating advanced solid tumors, and in the phase 2 part of this study, researchers want to study if the combination treatments are effective in ovarian cancer. Objectives: \- Phase 2 part of the study: To determine how effective this combination is in treating ovarian cancer. Eligibility: \- Phase 2 part of the study: Adults age 18 or older with advanced or recurrent ovarian cancer that has no standard treatment. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. They will have CT or MRI scans. For these, they will lie in a machine that takes pictures of their bodies. * Phase 2 part of the study requests the participants to have tumor samples removed. * Participants will get Durvalumab through an IV. A small plastic tube will be inserted into a vein. The drug will be given every 4 weeks until disease progression. * Participants will take olaparib or cediranib by mouth every day. * Every 28 days will be 1 cycle. For cycle 1, participants will have 2 study visits. All other cycles, they will have 1 visit. At these visits, they will repeat the screening procedures. * Patients will keep a drug and diarrhea diary. * Patients on cediranib will monitor their blood pressure and keep a blood pressure diary. * Participants who can become pregnant, or have a partner who can become pregnant, must practice an effective form of birth control. * After 12 cycles, participants will have 1-3 months of follow-up.

Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer

This is a single-arm, open-label, phase 2 clinical trial using a stratified Simon minimax two-stage design. The study aims to evaluate the efficacy and safety of low-dose apatinib (250 mg daily) combined with physician-selected single-agent chemotherapy (TPC, capecitabine preferred) in patients with HER2-positive or HER2-low advanced/metastatic breast cancer who progressed after prior ADC therapy (T-DXd or SHR-A1811). Patients are stratified by HER2 status, HR status, lines of prior ADC therapy, and metastasis sites. Approximately 56 patients will be enrolled. The primary endpoint is objective response rate (ORR). Secondary endpoints include PFS1, PFS2, TTP, safety, and OS.

Carolina Breast Cancer Study Phase 4

The Carolina Breast Cancer Study, Phase 4 (CBCS4) is a prospective, single-arm observational study examining interactions between tumor biology, health access, and patient behavior study. CBCS4 builds on prior phases that examined molecular and epidemiologic differences in breast cancer types and outcomes. Previous findings showed that certain breast cancer subtypes and genetic factors are linked to higher risks. While prior research uncovered subtype-specific risks and relevant genetic loci, persistent disparities especially among African American (AA) and American Indian/Alaska Native (AIAN) women suggest that tumor biology alone does not fully explain outcome differences. Other important factors, like access to healthcare, treatment adherence, and patient engagement must also be evaluated. Participants will complete a structured, in-person baseline interview covering breast cancer risk factors, quality of life, comorbidities, and initial treatment. Blood and/or saliva samples will be collected. Participants will provide consent for medical record abstraction and retrieval of tumor blocks. Medical record abstraction will be performed to confirm diagnoses through pathology reports and to collect clinical data, including TNM stage, ER/PR/HER2 status, and treatment history. Diagnostic tissue blocks will be requested from referring pathologists. Blood or saliva samples will be collected for DNA extraction, storage, and genotyping of breast cancer susceptibility genes. Tumor tissue blocks will be used for tissue microarray (TMA) construction, with up to nine cores obtained from each specimen. Central pathology review will be conducted to confirm diagnoses through evaluation of H\&E slides. TMAs will be analyzed by immunohistochemistry (IHC) to classify tumors into molecular subtypes, and a subset of samples will undergo RNA-based qtrs.-PCR for molecular subtype validation. Participants will be recontacted every 9 to 12 months for up to 10 years to update medical history, treatment information, and patient-reported outcomes. Longitudinal follow-up data will be used to assess treatment disparities, particularly among patients with aggressive tumor subtypes, evaluate quality of life and barriers to care using validated assessment tools, and support survivorship through the provision of educational updates and care navigation resources

ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer

This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.

A Study of LY4337713 in Participants With FAP-Positive Solid Tumors

This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.

Multimodal Respiratory Physiotherapy in Women Receiving Radiotherapy for Breast Cancer (RESPIRA-BC)

Radiotherapy is an important treatment for breast cancer, but it may affect lung function and physical ability, making everyday activities more difficult. Breathing exercises may help women recover after treatment, although more research is needed. The main aim of this pilot study was to assess whether a four-week respiratory physiotherapy programme was practical and safe for women treated for breast cancer with radiotherapy. The study also explored its potential benefits for lung function, physical ability, physical activity, fatigue and quality of life. Participants were randomly assigned to two groups. Both groups received patient education and an individualised exercise programme. In addition, one group performed breathing exercises at home using two devices: one to encourage deep breathing (incentive spirometry) and another to provide resistance when breathing out (positive expiratory pressure). The study compared both groups to explore whether adding these breathing exercises provided additional benefits.

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.

Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are: Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Parts B1-B7), Safety and tolerability (Parts B-8, B-9 and C), and characterization of the pharmacokinetics (Part D).

Window of Opportunity Trial of Neoadjuvant Olaparib and Durvalumab for Triple Negative or Low ER+ Breast Cancer

Window of Opportunity Trial of Olaparib and Durvalumab (MEDI4736) before Standard Neoadjuvant Chemotherapy for Stage II/III Triple Negative or Low ER+ Breast Cancer

Safety and Effectiveness Study of Single-Port Surgical System in Breast Tumor Surgery

This is a prospective, multicenter clinical study designed to evaluate the safety and effectiveness of remote surgery using the single-port thoracoabdominal endoscopic surgical system in breast tumor surgery. Eligible patients diagnosed with breast tumors will receive robotic-assisted remote surgery. The primary endpoints include safety indicators and surgical effectiveness parameters. The study aims to provide clinical evidence for the application of this surgical system in breast cancer treatment.

Increasing Breast and Colorectal Cancer Screening in the Community

The goal of the proposed study is to conduct a pilot randomized controlled trial (RCT) of Chi gung, a community-based intervention using peer education and tailored navigation to simultaneously improve colorectal (CRC) and breast cancer (BC) screening rates.

Artificial Intelligence Integration in Breast Cancer Screening: The ANIHTA Study

The goal of this observational study is to evaluate how artificial intelligence (AI) can be integrated into an organized breast cancer screening program for women aged 50-74 years undergoing mammography screening. The main questions it aims to answer are: * Can an AI-based workflow that identifies selected mammograms for review by a third radiologist improve or maintain the cancer detection rate compared with the current AI-supported double-reading workflow? * How would this AI-based workflow affect recall rates, biopsy referrals, false-positive results, interval cancers, radiologists' workload, and the number of cases requiring third-reader review? Researchers will compare the currently used screening strategy, in which mammograms are independently read by two radiologists with AI support, with an alternative AI-based strategy reconstructed using a target trial emulation approach. In the alternative strategy, predefined AI score thresholds will be used to identify selected cases for an offline review by an independent third radiologist. Participants will not be asked to undergo additional examinations or changes to their clinical care. Researchers will use routinely collected mammography screening data, AI scores, radiologists' readings, screening outcomes, and follow-up information. The alternative AI-based screening workflow will be evaluated retrospectively and will not affect participants' screening results or clinical management.

Breast Mammogram and Tissue Study

Background: Women whose mammograms show a lot of dense areas are more likely to develop breast cancer and to have cancers that are missed by mammograms. It is unclear why some factors lead to having dense breasts and why having dense breasts increases the risk of developing breast cancer. Objectives: To determine why some women s breasts look dense on mammograms. To determine what types of cells and tissues make up dense areas of breasts and why these tissues may be more likely to become cancerous. Eligibility: Women between 40 and 65 years of age who have not had breast cancer or received medicines or radiation for any type of cancer and who are scheduled to undergo a breast biopsy. Design: This study is conducted at the University of Vermont, in collaboration with the NCI. Participants undergo the following: * Review of their medical records collected over the last 2 years by the Vermont Mammography Registry. * Participation in a short telephone interview. * Height and weight measurement. * Testing of biopsy tissue collected for diagnosis or treatment. * Future contacts regarding health status for up to 10 years, including review of additional mammograms, removed tissues, questionnaires and medical records collected by the Vermont Mammography Registry during the 10-year study. Participants may also undergo the following optional procedures: * Provide a mouthwash sample for genetic testing. * Provide a blood sample to test for markers of dense mammograms or breast cancer.

Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02)

Based on different HR status, we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 + MBC.

A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer or Malignant Peritoneal Mesothelioma

Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory at Memorial Sloan Kettering to be changed (modified) to become MSLN-targeted CAR T cells, the CAR T-cell therapy that participants will receive during the study. Participant study therapy will take about 3-4 weeks.

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer

The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.

Hypofractionated LocoRegional Radiotherapy in Breast Cancer

The primary objective of this study is to determine if hypofractionated RT delivered over 1 week to the breast or chest wall and regional nodes (26Gy in 5 daily fractions) following BCS or mastectomy, is non-inferior to conventional fractionation to the breast or chest wall and regional nodes delivered over 3 weeks (40Gy in 15 daily fractions) in patients with node-positive breast cancer.

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Pembrolizumab and Paclitaxel in Hypermutated Breast Cancer

Abbreviated Title: Pembrolizumab in hypermutated breast cancer Trial Phase: II Clinical Indication: Hormone receptor-positive metastatic breast cancer Trial Type: Interventional Type of control: None Route of administration: Intravenous Trial Blinding: None Treatment Groups: Pembrolizumab plus Paclitaxel Number of trial subjects: Approximately 200 patients will be prescreened with whole exome sequencing. Then 52 patients will be enrolled in the treatment phase. Estimated enrollment period: 12 months Estimated duration of trial: The sponsor estimates that the trial will require approximately 48 months from the time the first subject signs the informed consent until the last subject's last visit. Duration of Participation: 12 months Estimated average length of treatment per patient: 8 months

A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called disitamab vedotin) for the possible treatment of people with breast cancer that is hard to treat and has spread in the body (advanced cancer). This study is seeking participants who: * have breast cancer that is hard to treat and has spread in the body (advanced cancer) * have tumors that have HER2 on them * have received previous treatment for their advanced breast cancer All participants in this study will receive disitamab vedotin at the study clinic once every 2 weeks as an intravenous (IV) infusion (given directly into a vein). Participants will take the study medicine until they or their doctor decides to stop. This might be because their cancer is getting worse, the study medicine is no longer helping, they have bad side effects, or they wish to stop taking the study medicine. During this time, the participants will have study visits every 2 weeks. After the participants have stopped taking the study medicine, they will have follow-up visits about every 6 weeks unless their cancer gets worse. After that, they will have follow-up phone calls about every 12 weeks. The study team will look at the experiences of people receiving the study medicine. This will help the study team decide if the study medicine is safe and effective.