Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer
NCT05941520 · Breast Atypical Hyperplasia, Breast Carcinoma, Breast Ductal Carcinoma In Situ
RecruitingThis phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.
PhasePhase 2
TypeInterventional
Age35 Years
WhereDuarte, California, United States + 3 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
NCT07361562 · Advanced Solid Tumor, Adult,
ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification
RecruitingThis is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 14 more
SponsorCogent Biosciences, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
RecruitingBreast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting. The purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.
PhasePhase 2
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States + 2 more
SponsorNorthwestern University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies
NCT05417594 · Advanced Solid Malignancies
RecruitingThis study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progressed.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 130 Years
WhereLa Jolla, California, United States + 31 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
NCT01042379 · Breast Neoplasms,
Breast Cancer, Breast Tumors
RecruitingThe purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 41 more
SponsorQuantumLeap Healthcare Collaborative
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
NCT06500481 ·
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Non-Small Cell Carcinoma
RecruitingThis phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and/or prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 57 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
NCT03729115 ·
Breast Cancer RecruitingThis study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.
PhaseNA
TypeInterventional
Age25 Years
WhereLa Jolla, California, United States + 2 more
SponsorUniversity of Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
RecruitingThis is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 20 more
SponsorOana Danciu
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
NCT06500455 ·
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Digestive System Carcinoma
RecruitingThis phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
PhasePhase 3
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 269 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of NX-1607 in Adults With Advanced Malignancies
NCT05107674 ·
Ovarian Cancer, Epithelial, Gastric Cancer, GastroEsophageal Junction (GEJ) Cancer
RecruitingThis is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 16 more
SponsorNurix Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Preparing FIM-BCS - A Lifestyle Modification for African-American Breast Cancer Survivors
NCT06504914 ·
Hypertension, Obesity, Nutrition, Healthy
RecruitingHypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention \- grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.
PhaseNA
TypeInterventional
Age18 Years – 99 Years
WhereChicago, Illinois, United States
SponsorUniversity of Illinois at Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors
RecruitingA Study of Emi-Le in Participants with Solid Tumors
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 25 more
SponsorDay One Biopharmaceuticals, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
NCT06418204 · Breast Carcinoma, Colorectal Carcinoma, Lung Non-Small Cell Carcinoma
RecruitingThis is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.
Phase—
TypeObservational
Age18 Years
WhereFairbanks, Alaska, United States + 466 more
SponsorWake Forest University Health Sciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mirai-MRI: Validation of AI Models for Breast Cancer Risk
NCT07121972 · Cancer Risk,
Breast Cancer Risk RecruitingThis is a multi-center, single arm trial to evaluate the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment. Mirai is an accurate cancer risk model based on full-resolution mammograms.
PhaseNA
TypeInterventional
Age40 Years – 89 Years
WhereSan Diego, California, United States + 3 more
SponsorUniversity of California, San Francisco
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
NCT06926868 · Breast Neoplasms
RecruitingThe purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereHot Springs, Arkansas, United States + 294 more
SponsorBristol-Myers Squibb
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
NCT03990896 ·
Breast Cancer RecruitingThis research is to evaluate the effectiveness of Talazoparib as a potential treatment for metastatic breast cancer with a BRCA 1 or BRCA 2 mutation.
PhasePhase 2
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States + 6 more
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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)
NCT06312176 · Breast Neoplasms
RecruitingThe 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.
PhasePhase 3
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 258 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care
NCT05483283 ·
Breast Cancer RecruitingThe investigator and study staff will identify, recruit and randomize Latina participants with elevated genetic and Social Determinants of Heath (SDH) risks. Within 1 week of enrollment, all Latina Aim 1 participants in both study arms will engage in three 30-minute, individual, phone-based sessions with the study team across 3 consecutive weeks
PhaseNA
TypeInterventional
Age30 Years
WhereChicago, Illinois, United States
SponsorUniversity of Illinois at Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
RecruitingThe primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer
PhasePhase 3
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 305 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
RecruitingThe purpose of this study is to determine if a combination of two drugs sacituzumab govitecan and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood. This research study involves the following investigational drugs: * Sacituzumab govitecan * Atezolizumab
PhasePhase 2
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States + 6 more
SponsorDana-Farber Cancer Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts