Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).
This page lists clinical trials related to Skin Cancer from the ClinicalTrials.gov database.
Trial Summary
- Total studies: 50
- Recruiting: 17
- Active, not recruiting: 12
- Completed: 12
- Other: 9
Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.
Recruiting Trials
NCT00027274 — Cancer in Inherited Bone Marrow Failure Syndromes
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 4000 |
| Study Type | OBSERVATIONAL |
| Conditions | Diamond Blackfan Anemia; Dyskeratosis Congenita; Fanconi Anemia; Shwachman Diamond Syndrome; Inherited Bone Marrow Failure Syndrome, Aplastic Anemia |
Background:
A prospective cohort of Inherited Bone Marrow Failure Syndrome (IBMFS) will provide new information regarding cancer rates and types in these disorders.
Pathogenic variant(s) in IBMFS genes are relevant to carcinogenesis in sporadic cancers.
Patients with IBMFS who develop cancer differ in their genetic and/or environmental features from patients with IBMFS who do not develop can…
NCT00032513 — Genetic Studies of Chronic Active Epstein-Barr Disease
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 300 |
| Study Type | OBSERVATIONAL |
| Conditions | Chronic Active Epstein-Barr Virus |
Epstein-Barr virus (EBV) is a member of the human herpes virus family that infects more than 95 percent of the U.S. population. Most infections occur in childhood and cause no symptoms; in adolescents and adults, EBV often causes infectious mononucleosis. It has also been associated with certain forms of cancer. Chronic Epstein-Barr virus (CAEBV) is a rare disease, primarily of children and you…
NCT00040352 — Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 3000 |
| Study Type | OBSERVATIONAL |
| Conditions | Melanoma; Dysplastic Nevus Syndrome |
This study will investigate how genetic and environmental factors contribute to the development of melanoma, a type of skin cancer, and related conditions.
Individuals >=4 weeks with a personal or family history of melanoma or atypical spitzoid/Spitz tumor may be eligible for this study. Participants will:
- Fill out one or two questionnaires about their personal and family medical history. …
NCT01174121 — Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 332 |
| Study Type | INTERVENTIONAL |
| Conditions | Metastatic Colorectal Cancer; Metastatic Pancreatic Cancer; Metastatic Ovarian Cancer; Metastatic Breast Carcinoma; Metastatic Endocrine Tumors/ Neuroendocrine Tumors |
| Interventions | ; ; |
Background:
The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients’ tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know i…
NCT01905826 — Natural History Study of GATA2 Deficiency and Related Disorders
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Enrollment | 600 |
| Study Type | OBSERVATIONAL |
| Conditions | GATA2 Deficiency |
Background:
- GATA2 deficiency is a genetic disorder that can cause problems with a person s immune system and other body systems. Some people who have this disorder develop few problems from it. Others can have a wide range of health problems, from skin problems, to hearing loss, to cancer. These problems can happen at any age. Researchers want to study GATA2 deficiency to better understand …
NCT05053230 — A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Enrollment | 324 |
| Study Type | INTERVENTIONAL |
| Conditions | Head and Neck Cancer; Head and Neck Tumor; Thoracic Tumor; Thoracic Cancer; Gynecologic Cancer |
| Interventions | ; |
The overarching long-term goal of the Integrative Medicine for Patient-reported Outcomes Values and Experience (IMPROVE) research program is to evaluate whether integrating a virtual mind-body programming, Integrative Medicine at Home (IM@Home), will improve patient perceived values, outcomes, and experiences as they undergo systemic cancer treatment such as chemotherapy, immunotherapy, radioth…
NCT05827081 — Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 1400 |
| Study Type | INTERVENTIONAL |
| Conditions | Early Breast Cancer |
| Interventions | ; ; |
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage II…
NCT06492616 — A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Stemline Therapeutics, Inc. |
| Enrollment | 4220 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions | ; ; |
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
NCT06444269 — Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Enrollment | 53 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions | ; |
1. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor
NCT06562192 — Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 162 |
| Study Type | INTERVENTIONAL |
| Conditions | Pancreatic Ductal Adenocarcinoma; Non-small Cell Lung Cancer; HR+/HER2- Ductal and Lobular Breast Cancer; Triple Negative Breast Cancer; Colorectal Cancer |
| Interventions | ; |
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-NNS309 and the safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast c…
NCT06830720 — A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 3250 |
| Study Type | OBSERVATIONAL |
| Conditions | Breast Neoplasms |
| Interventions | ; ; |
This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.
NCT06995898 — The Vanguard Study: Testing a New Way to Screen for Cancer
| Status | Recruiting |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 24000 |
| Study Type | INTERVENTIONAL |
| Conditions | Bladder Carcinoma; Breast Carcinoma; Colorectal Carcinoma; Esophageal Carcinoma; Gastric Carcinoma |
| Interventions | ; ; |
The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden o…
NCT06985056 — Reducing Symptom Burden Through Physical Exercise in Melanoma Patients
| Status | Recruiting |
| Phase | N/A |
| Sponsor | Universität Duisburg-Essen |
| Enrollment | 86 |
| Study Type | INTERVENTIONAL |
| Conditions | Malignant Melanoma |
| Interventions |
The aim of the clinical trial is to determine whether regular exercise can reduce fatigue in adult patients with stage IIb-IV melanoma undergoing immunotherapy or targeted therapy. Additionally, we will investigate whether a supervised exercise program improves patients’ quality of life, cognitive skills, and physical fitness compared to a control group without structured exercise. We will also…
NCT06982521 — Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Relay Therapeutics, Inc. |
| Enrollment | 540 |
| Study Type | INTERVENTIONAL |
| Conditions | PIK3CA Mutation; HER2- Negative Breast Cancer; Hormone Receptor Positive Tumor; Breast Cancer; Metastatic Breast Cancer |
| Interventions | ; ; |
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
NCT07086105 — A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Adze Biotechnology Australia Pty Ltd |
| Enrollment | 30 |
| Study Type | INTERVENTIONAL |
| Conditions | Metastatic Melanoma |
| Interventions |
This is Phase I, open label, multi-center clinical trial evaluating an investigational treatment, Adze1.C. Adze1.C is a type of oncolytic virus therapy for adults with advanced Melanoma that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight tumors. The purpose of this study …
NCT07671885 — Evaluating the Response-Guided Therapy With Neoadjuvant Endocrine Therapy to Optimize Adjuvant Treatment in Premenopausal HR+/HER2- Breast Cancer (JCOG2402, Young HOPE)
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tokyo Women’s Medical University |
| Enrollment | 950 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions | ; |
Young HOPE/JCOG2402 is a multicenter, randomized phase III study designed to evaluate response-guided therapy following neoadjuvant endocrine therapy to optimize adjuvant treatment in premenopausal HR+/HER2- Breast Cancer.
Premenopausal women with intermediate-risk HR-positive/HER2-negative breast cancer derive benefit from the addition of chemotherapy to endocrine therapy. However, previous s…
NCT07528716 — Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Enrollment | 280 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions | ; ; |
Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with early or locally advanced human epidermal growth factor receptor 2 (HER2)-pos…
Active, Not Recruiting
NCT02465060 — Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
| Status | Active, not recruiting |
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 6452 |
| Study Type | INTERVENTIONAL |
| Conditions | Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma |
| Interventions | ; ; |
This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not respond to treatment (refractory). Patients must have progressed following at leas…
NCT02445391 — Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Sponsor | ECOG-ACRIN Cancer Research Group |
| Enrollment | 415 |
| Study Type | INTERVENTIONAL |
| Conditions | Estrogen Receptor Negative; HER2/Neu Negative; Invasive Breast Carcinoma; Progesterone Receptor Negative; Stage II Breast Cancer |
| Interventions | ; ; |
This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of …
NCT02650986 — Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
| Status | Active, not recruiting |
| Phase | Phase 1 / Phase 2 |
| Sponsor | Roswell Park Cancer Institute |
| Enrollment | 15 |
| Study Type | INTERVENTIONAL |
| Conditions | Advanced Fallopian Tube Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Melanoma; Advanced Ovarian Carcinoma; Advanced Primary Peritoneal Carcinoma |
| Interventions | ; ; |
This phase I/IIa trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advanced). A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Pla…
NCT03747120 — Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
| Status | Active, not recruiting |
| Phase | Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Enrollment | 138 |
| Study Type | INTERVENTIONAL |
| Conditions | HER2-positive Breast Cancer; Breast Cancer |
| Interventions | ; ; |
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab ) in chemo naive patients with invasive human epid…
NCT04328844 — A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers
| Status | Active, not recruiting |
| Phase | Phase 1 |
| Sponsor | iOnctura |
| Enrollment | 210 |
| Study Type | INTERVENTIONAL |
| Conditions | Solid Tumor, Adult; Non-Hodgkin Lymphoma, Adult; NSCLC; Myelofibrosis; Uveal Melanoma |
| Interventions | ; ; |
The objective of study IOA-244-101 is to determine whether IOA-244 is safe and tolerable in cancer patients (Part A). In addition, the study will assess whether IOA-244 can increase the anti-tumour immune response in patients both as monotherapy and in combination pemetrexed/cisplatin/avelumab (Part B Mesothelioma and NSCLC 1st line), in combination with avelumab (Part B Cutaneous Melanoma and …
NCT04291105 — Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
| Status | Active, not recruiting |
| Phase | Phase 2 |
| Sponsor | Vyriad, Inc. |
| Enrollment | 87 |
| Study Type | INTERVENTIONAL |
| Conditions | Melanoma; Head and Neck Squamous Cell Carcinoma; Colo-rectal Cancer |
| Interventions | ; |
This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. (CRC and melenoma cohorts are now closed to new patients)
NCT04521686 — Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations
| Status | Active, not recruiting |
| Phase | Phase 1 |
| Sponsor | Eli Lilly and Company |
| Enrollment | 200 |
| Study Type | INTERVENTIONAL |
| Conditions | Cholangiocarcinoma; Chondrosarcoma; Glioma; Any Solid Tumor |
| Interventions | ; ; |
This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangi…
NCT04567420 — DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
| Status | Active, not recruiting |
| Phase | Phase 2 |
| Sponsor | Criterium, Inc. |
| Enrollment | 70 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions | ; ; |
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)
NCT05015816 — MoleGazer Development Feasibility Study
| Status | Active, not recruiting |
| Phase | N/A |
| Sponsor | Oxford University Hospitals NHS Trust |
| Enrollment | 374 |
| Study Type | INTERVENTIONAL |
| Conditions | Melanoma (Skin); Moles Multiple Benign |
| Interventions |
Melanoma (skin cancer) frequently develops from existing moles on the skin. Current practice relies on expert dermatologists being able to successfully identify new/changing moles in individuals with multiple moles. Total body photography (TBP-high-quality images of the entire skin) can track and monitor moles over time to detect melanoma.
However, TBP is currently used as a visual guide when …
NCT05038735 — Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 210 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions | ; ; |
The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI p…
NCT05703178 — Web-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Sponsor | Northwestern University |
| Enrollment | 452 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer; Arthralgia; Pain, Chronic |
| Interventions | ; |
The main goal of this clinical trial is to test benefits of completing online pain coping skills training program in women who have been diagnosed with stage I-III breast cancer, who have completed their primary cancer treatment, who are taking an AI medication, and who have arthralgia. Arthralgia is a type of joint, bone, and muscle pain that is a common side effect of AI medications. The main…
NCT05607004 — (Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
| Status | Active, not recruiting |
| Phase | Phase 2 |
| Sponsor | Atossa Therapeutics, Inc. |
| Enrollment | 87 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Neoplasms; Invasive Breast Cancer; Estrogen-receptor-positive Breast Cancer; HER2-negative Breast Cancer |
| Interventions | ; |
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or “SERM”, which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.
The PK part (how the body proces…
Not Yet Recruiting
NCT07691255 — MELanoma Brain Metastasis Treated With CYberknife
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | European Institute of Oncology |
| Enrollment | 50 |
| Study Type | OBSERVATIONAL |
| Conditions | Melanoma (Skin Cancer) |
Melanoma is a type of cancer that can spread to the brain, making the disease harder to treat and worsening both survival and quality of life.
In recent years, treatments have improved significantly thanks to advances in surgery, radiotherapy, immunotherapy, and targeted therapy. These new treatments have greatly increased survival rates for patients with metastatic melanoma.
This study focus…
NCT07005297 — Clinical Genetics Branch Eligibility Screening Survey
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 1000 |
| Study Type | OBSERVATIONAL |
| Conditions | Melanoma; Li-Fraumeni Syndrome; Pulmonary Blastoma; Chordoma; Congenital Bone Marrow Failure Syndromes |
Background:
Clinical Genetics Branch (CGB) researchers study individuals and populations at high genetic risk of cancer in order to improve our understanding of cancer and to improve cancer care. There are currently 6 open clinical genetics studies at the CGB eligible for this screening process.
- 02C0052: Etiologic Investigation of Cancer Susceptibility in Inherited Bone Marrow Failure Syndr…
NCT07619534 — Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 139 |
| Study Type | OBSERVATIONAL |
| Conditions | Breast Cancer; Breast Carcinoma; Cancer of the Breast; Malignant Neoplasm of Breast |
| Interventions |
Background:
Breast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain. Breast cancer that spreads to the brain is often fatal. Researchers want to know if tumor DNA found in spinal fluid, blood, or tumor tissue can help predict when the cancer will spread to the brain. They want to collect these fluid and tissue samples for research.
Objecti…
NCT07689929 — Research on AI Models for Predicting Breast Cancer Treatment Effectiveness to Guide Her-2 Targeted ADC Therapy
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Zhejiang Cancer Hospital |
| Enrollment | 900 |
| Study Type | OBSERVATIONAL |
| Conditions | Breast Cancer |
This study aims to develop an AI-based predictive tool to help clinicians more accurately determine whether breast cancer patients can benefit from HER-2-targeted antibody-drug conjugate (T-DXd) therapy before treatment. While HER-2-targeted ADC drugs have significantly improved outcomes for patients with HER-2 positive and low-expression advanced breast cancer, there are notable individual dif…
NCT07619365 — Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Sponsor | Washington University School of Medicine |
| Enrollment | 60 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer |
| Interventions | ; |
The purpose of this study is to evaluate use of lovastatin, a drug that may lower CAV-1 levels, in order to increase HER2 expression on cells and enhance the uptake and efficacy of trastuzumab deruxtecan (T-DXd) in HER2-low and ultralow advanced metastatic breast cancer. Trastuzumab deruxtecan (T-DXd) is an FDA approved antibody drug conjugate for HER2-low and ultralow breast cancer and lovasta…
NCT07690852 — Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | City of Hope Medical Center |
| Enrollment | 423 |
| Study Type | OBSERVATIONAL |
| Conditions | Breast Carcinoma |
| Interventions |
This study evaluates patient and provider attitudes about environmental exposure risk assessments into clinical care for female patients at average or high risk for breast cancer and/or diagnosed with early onset breast cancer.
NCT07689721 — ctDNA-Guided Intraventricular Therapy for CNS Malignancies
| Status | Not yet recruiting |
| Phase | N/A |
| Sponsor | Alireza Mansouri |
| Enrollment | 77 |
| Study Type | INTERVENTIONAL |
| Conditions | Leptomeningeal Disease; Glioblastoma; Brain Metastases; Non-Small Cell Lung Cancer; Breast Cancer |
| Interventions |
This prospective, single-center study will evaluate whether cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) testing using the Belay Summit assay can improve the clinical management of patients with malignant gliomas or brain metastases from non-small cell lung cancer (NSCLC) or breast cancer who are suspected of having central nervous system (CNS) disease. Patients undergoing clinically…
Completed Trials
NCT00001813 — Examination of Clinical and Laboratory Abnormalities in Patients With Defective DNA Repair: Xeroderma Pigmentosum, Cockayne Syndrome, or Trichothiodystrophy
| Status | Completed |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 709 |
| Study Type | OBSERVATIONAL |
| Conditions | Cockayne Syndrome; Skin Neoplasms; Xeroderma Pigmentosum; Trichothiodystrophy Syndromes; Genodermatosis |
Four rare genetic diseases, xeroderma pigmentosum (XP), Cockayne syndrome (CS), the XP/CS complex and trichothiodystrophy (TTD) have defective DNA excision repair although only XP has increased cancer susceptibility. We plan to perform careful clinical examination of selected patients with XP, XP/CS, CS, or TTD and follow their clinical course. We will obtain tissue (skin, blood, hair, buccal s…
NCT00006421 — Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Annual Follow-Up Study
| Status | Completed |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 200 |
| Study Type | OBSERVATIONAL |
| Conditions | Breast Cancer |
| Interventions |
This study will explore new screening methods for early detection of breast and ovarian cancer in women at high risk for these diseases, because they have an altered breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene. It will also try to determine if breast tissue characteristics in women with a BRCA1 or BRCA2 mutation differ from those in women with a normal gene.
Premenopausal women bet…
NCT00040222 — Clinical, Genetic, Behavioral, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Breast/Ovarian Cancer
| Status | Completed |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 377 |
| Study Type | OBSERVATIONAL |
| Conditions | Familial Ovarian Cancer; Familial Breast Cancer; BRCA1-associate Malignancies; BRCA2-associated Malignancies |
Individuals and families with known or suspected syndromes that include breast, ovarian or genetically-related cancers are enrolled in this family study, which is a syndrome-specific sub-set of the long-standing DCEG Human Genetics Program umbrella family studies protocol (78-C-0039). Cancer outcomes are documented through review of medical, vital, and pathology records. Selected individuals an…
NCT00314119 — Natural History and Biology of Skin Neurofibromas in Neurofibromatosis Type 1
| Status | Completed |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 17 |
| Study Type | OBSERVATIONAL |
| Conditions | Neurofibromatosis Type 1; Neurofibroma |
This study will explore the growth of dermal neurofibromas (skin tumors) in patients with neurofibromatosis type 1 (NF1). Investigators will try to learn: 1) how fast (or slow) these benign tumors grow in NF1, 2) how often new tumors appear and 3) what genes are involved in the growth of the tumors.
Men and women between 20 and 50 years of age diagnosed with NF1 and their biological parents ar…
NCT00475761 — Breast Mammogram and Tissue Study
| Status | Completed |
| Phase | N/A |
| Sponsor | National Cancer Institute (NCI) |
| Enrollment | 466 |
| Study Type | OBSERVATIONAL |
| Conditions | Breast Neoplasms |
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…
NCT03671330 — Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 327 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions | ; ; |
This was a randomized, double-blind, placebo-controlled study conducted in Chinese women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, plus an open-label, single-arm pharmacokinetic (PK) subset in postmenopausal Chinese women with HR+, HER2- advanced breast cancer.
NCT04773951 — A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JS004 in Advanced Solid Tumors
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. |
| Enrollment | 47 |
| Study Type | INTERVENTIONAL |
| Conditions | Melanoma; Renal Carcinoma; Urothelial Carcinoma |
| Interventions |
An open-label, dose-escalation, phase I clinical study to evaluate the safety and tolerability of JS004 injection in the patients with advanced solid tumors who have failure in standard of care and are unable to tolerate standard of care and/or have no available standard of care. The study is divided into screening period, treatment period, and follow-up period.
- Screening period: Subjects w…
NCT05365230 — A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer
| Status | Completed |
| Phase | Phase 4 |
| Sponsor | Ottawa Hospital Research Institute |
| Enrollment | 261 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions | ; |
After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. Therefore the inves…
NCT05565534 — Diabetes Care for Breast Cancer Patients
| Status | Completed |
| Phase | N/A |
| Sponsor | Weill Medical College of Cornell University |
| Enrollment | 74 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer; PreDiabetes; Type 2 Diabetes |
| Interventions |
The goal of this study is to find a new way to make diabetes care better for patients with breast cancer and diabetes who are currently receiving cancer treatment. We will have two groups, the researchers will decide who is in which group. One group will be working with a nurse who is trained in diabetes care while the other does not. This will allow the investigators to see if having a trained…
NCT06115902 — A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
| Enrollment | 153 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions |
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), an enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 1/Pha…
NCT06386263 — HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
| Status | Completed |
| Phase | N/A |
| Sponsor | AstraZeneca |
| Enrollment | 22 |
| Study Type | OBSERVATIONAL |
| Conditions | Unresectable Breast Cancer; Metastatic Breast Cancer; HER2-low Expressing Breast Cancer; HER2-positive Breast Cancer |
| Interventions |
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively.
Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related o…
NCT06529120 — Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas
| Status | Completed |
| Phase | N/A |
| Sponsor | Duke University |
| Enrollment | 15 |
| Study Type | INTERVENTIONAL |
| Conditions | Breast Cancer |
| Interventions |
Women with breast cancer often experience multiple difficult symptoms, for example insomnia, fatigue, stress, and pain. This study is being done to test a mindfulness-based insomnia and symptom management intervention for women with breast cancer (Nite2Day). Participants will complete six, 45-60 minute intervention sessions with a study therapist. Intervention sessions will be conducted remotel…
Other (Terminated)
NCT04251533 — Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
| Status | Terminated |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Enrollment | 137 |
| Study Type | INTERVENTIONAL |
| Conditions | Triple Negative Breast Neoplasms |
| Interventions | ; ; |
The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)
NCT06984328 — Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07)
| Status | Terminated |
| Phase | Phase 2 |
| Sponsor | Genmab |
| Enrollment | 1 |
| Study Type | INTERVENTIONAL |
| Conditions | Cutaneous Melanoma; Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID); Metastatic Cutaneous Melanoma (Stage IV) |
| Interventions | ; |
The goal of this clinical trial is to learn about the effectiveness and safety of the bispecific antibody acasunlimab (also known as DuoBody®-PD-L1x4-1BB) when given either alone or together with the cancer drug pembrolizumab in participants with locally advanced or metastatic melanoma of the skin. All participants will receive active drugs; no one will be given a placebo.
The trial duration w…