Treatment Trials

6,491 Clinical Trials for Various Conditions

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Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
Description

This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in the United States Flatiron Health Database.

Conditions

Advanced/Metastatic HER2-negative Breast Cancer

Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information: Administrative Supplement Study
Description

The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.

Conditions

Breast Cancer Female

Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in Breast Cancer Patients Undergoing Radiation
Description

This pilot study will evaluate the feasibility of at least twice daily use of azelaic acid in breast cancer patients undergoing radiation treatment.

Conditions

Breast Cancer

Multi-center MRD Registry for Inflammatory Breast Cancer
Description

To collect data from participants with IBC who may have had MRD testing and may have surgery in the future.

Conditions

Breast Cancer

5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
Description

The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.

Conditions

Breast Cancer, Invasive Carcinoma of Breast, Ductal Breast Carcinoma in Situ

A Phase Ib/II Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC)
Description

The goal of this clinical research study is to find the best dose of the drugs cyclophosphamide and axatilimab that can be given in combination with the standard dose of retifanlimab to patients with metastatic TNBC.

Conditions

Breast Cancer

Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer
Description

This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.

Conditions

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma

Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
Description

This is a Phase II Trial to assess the impact of omitting adjuvant chemotherapy based on patient's selection on treatment persistence of CDK4/6 inhibitor, ribociclib (Kisqali), in a well-defined subgroup of patients with resected estrogen receptor (ER)-positive, HER2-negative, lymph node-positive breast cancer, but whose tumor profiling indicates a less aggressive biological nature (OncotypeDx 21-gene recurrence score RS 0-25).

Conditions

HER2 Negative Breast Cancer

Collecting Patient-Reported Experiences With Radiation Dermatitis in Breast Cancer Patients Undergoing Radiotherapy
Description

This study evaluates patient-reported experiences of radiation dermatitis in patients with breast cancer undergoing radiotherapy.

Conditions

Breast Carcinoma

A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer
Description

This clinical trial studies whether a patient navigation (PN) intervention can be used to improve risk management among women at high risk of breast cancer. Women with a family history of breast cancer have a higher lifetime risk of developing it. Risk management can benefit women at high risk of breast cancer and can include surveillance routines, preventative surgeries, and medications that can dramatically lower the risk of breast cancer and allow early detection. Although risk management can benefit women at high risk of breast cancer, only a small amount actually use it. PN is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN intervention in this study is designed to help give women the information and support they need to make choices about their breast cancer risk that they feel good about, which may improve risk management.

Conditions

Breast Carcinoma

HER2 Vaccine for Locally Advanced Breast Cancer
Description

The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.

Conditions

Breast Cancer, HER2-positive Breast Cancer

A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer
Description

This is a rollover study for patients enrolled in the discontinued ELONA clinical trial (ONA-XR-103) with the primary objective to characterize the safety of elacestrant in combination with onapristone either alone or in combination.

Conditions

Breast Cancer

The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors
Description

The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.

Conditions

Breast Cancer Survivor, Cancer Related Cognitive Difficulties, Sleep, Quality of Life

Impact of Artificial Intelligence on Breast Cancer Screening
Description

The goal of this clinical trial is to compare patient-centered outcomes when 3D screening mammograms are interpreted with versus without a leading FDA-cleared AI decision-support tool in real-world U.S. settings and to assess patient's perspectives on AI in medicine. The main questions it aims to answer are: 1. Will AI use be associated with an increase in cancer detection and an initially higher recall rate as radiologists start using AI, followed by a recall rate comparable to that without AI (no more than 1.5 percentage-points higher) after a learning curve period? Will AI use will be associated with lower rates of missed breast cancers and similar rates of false alarms after a learning curve period? 2. Will improved patient outcomes with AI be most pronounced for exams on women who are White, older, and have less dense breasts, and on baseline exams? Will AI aid patient outcomes when the interpretation is by radiologists with less clinical experience, lower annual interpretive volume, and less tolerance of ambiguity? Yet, will there be greater automation bias (the tendency for humans to defer to a computer algorithms' results) noted among these radiologists? 3. What are patients' perspectives on AI in mammography, including their confidence in breast cancer screening when interpreted with vs. without AI? What are patients' perspectives on the importance of the study results? Researchers will compare patient-centered outcomes when 3D screening mammograms are interpreted with versus without a leading FDA-cleared AI decision-support tool in real-world U.S. settings. This trial will include all adult patients undergoing 3D mammography breast cancer screening at imaging facilities across University of California at Los Angeles and University of Washington health systems and all radiologists interpreting breast cancer screening. All screening mammograms at these facilities will be randomized to either intervention (radiologist with AI support) versus usual care (radiologist alone) to see if interpreting these mammograms with the AI tool's assistance improves patient outcomes.

Conditions

Breast Cancer Screening, Artificial Intelligence (AI)

Breast Cancer Implementation Science Study With Educational Intervention
Description

A study uniquely focused on system-based practice change, measuring the impact of educational interventions on both patients and clinicians for the recognition and management of treatment-related adverse effects for HER2+/HER2 low breast cancer patients on or about to start on HER2 targeted antibody drug conjugates (fam-trastuzumab deruxtecan-nxki or ado-trastuzumab emtansine) and shared decision-making methodologies to improve adverse event (AE) management and patient-clinician communications.

Conditions

Breast Cancer

A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Description

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC). The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).

Conditions

Triple Negative Breast Cancer

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)
Description

The 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.

Conditions

Breast Neoplasms

Herbs & Supplements in Breast Cancer Usage, Impact, and Personalized Approaches for Diverse Populations
Description

This research study is enrolling participants diagnosed with breast cancer and receiving/received chemotherapy and/or endocrine therapy. The study's primary objective is to assess the differences in the use of herbs and supplements among the populations served at Cleveland Clinic Florida and Ohio by administering a participant-reported questionnaire.

Conditions

Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast Carcinoma

Video-Conferenced Stress Management and Relaxation Training (VSMART) For Alabama Breast Cancer Survivors
Description

In a sample of Alabama breast cancer survivors, the proposed study tests the feasibility and acceptability of a stress management program that has been shown to improve health and wellbeing in a general population of patients with a history of breast cancer. The study will also get feedback (e.g., implementation barriers and facilitators) from relevant stakeholders.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
Description

This is a phase II, randomized, placebo-controlled trial designed to evaluate the efficacy of fezolinetant (45 mg a day) vs. placebo in reducing moderate to severe vasomotor symptoms (VMS) in breast cancer survivors on endocrine therapy (tamoxifen, aromatase inhibitors). The trial will proceed in a single stage and the total of 92 patients will be randomized in 1:1 fashion to fezolinetant or placebo arm respectively.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer
Description

This clinical trial studies how well a chemotherapy-induced peripheral neuropathy (CIPN) decision aid works in improving chemotherapy decision making among patients with breast cancer. CIPN involves numbness or tingling in the hands or feet and is a debilitating side effect of several commonly used classes of cancer drugs. CIPN symptoms are typically minor at first but can progress with continued treatment to severe symptoms that can affect long-term function, falls risk, and quality of life. Symptoms sometimes resolve after treatment but in patients who experienced CIPN, symptoms are still present 1 year post-treatment in about two-thirds of patients and 3 years post-treatment in approximately half of the patients. Previous studies indicate patients lack awareness of long-term CIPN symptoms. A decision aid that provides information about permanent CIPN, that helps patients understand their treatment priorities, and prepares them for a discussion with their medical oncologist may lead to improvements in treatment decision making, satisfaction with decision making, and ultimately increase patient's achievement of their treatment goals.

Conditions

Breast Carcinoma

Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
Description

This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (VMAT) works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges, Stage IV Lung Cancer AJCC v8

Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
Description

This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy. The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.

Conditions

Breast Cancer, Early-stage Breast Cancer, Ductal Carcinoma in Situ, DCIS

The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer
Description

The goal of this observational study is to learn if participants agree to take part in the study, if the methods we are using for the study are feasible for the participants and the researchers, and to study how well two tools (tissue dielectric constant and ultrasound) measure breast edema after breast conserving surgery for breast cancer. Participants who agree to be in the study will be asked to come in for one appointment of approximately two hours. All data will be collected during this one visit. Participants will be asked to fill out two questionnaires regarding their symptoms, and one questionnaire regarding their surgical scar. The research staff will conduct a clinical examination, measure breast edema using ultrasound and tissue dielectric constant, measure arm volume with the perometer and fluid with the SOZO, and take photographs of both breasts.

Conditions

Breast Edema, Breast Lymphedema, Lymphedema, Breast Cancer, Lymphedema

EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
Description

This clinical research study is to learn about the effects of giving radiotherapy alone after lumpectomy to patients who have early-stage, low-risk breast cancers and who are 60 years of age or older.

Conditions

Breast Cancer

SDM POSSIBLE: a Breast Cancer Treatment Decision Aid for Women 70+ with Low-Risk Stage I Breast Cancers
Description

Investigators aim to conduct a type 1 hybrid effectiveness-implementation surgeon-level cluster randomized clinical trial (RCT) of a multi-level intervention, a shared decision making training for surgeons plus patient decision aid vs. usual care (UC), at 6 large health systems in 4 regions to learn the intervention's effectiveness. Decision aids will be mailed and sent via patient portal and/or via email (when portal/email addresses are available) to patients before their first surgical encounter. The central hypothesis is that the novel intervention will be a key resource to support shared decision making leading to higher quality treatment decisions and as result improved care and outcomes.

Conditions

Breast Neoplasm, Breast Neoplasms, Breast Cancer, ER+ Breast Cancer, HER2-negative Breast Cancer

Long-term Safety of Nipple Sparing Mastectomy in Women With GPV in Breast Cancer
Description

Patients with a germline pathogenic variant (GPV) in high-penetrance breast cancer susceptibility genes who are considering risk reducing mastectomy (RRM) often strongly desire to keep their nipple areola complex but inquire as to whether it is safe to do so. Relative to traditional or skin sparing mastectomy (SSM) techniques, nipple sparing mastectomy (NSM) is associated with improved psychosocial and sexual well-being and is significantly better for body image and reducing feelings of disfigurement. Despite this, guidelines have yet to endorse the use of NSM over other RRM techniques, stating that more data and longer follow-up are needed to confirm it as a safe and effective strategy in GPV carriers. As NSM was not routinely adopted in high-risk patient populations undergoing RRM before 2010, there has been little data to inform the long-term oncologic safety of NSM. Well-designed studies have reported low to negligible rates of subsequent breast cancer in BRCA1/2 carriers following NSM, but have been limited by short median follow-up of less than 3 years. The current study is designed to confirm, with longer follow-up, prior findings on the oncologic safety of NSM in unaffected BRCA1/2 carriers. The investigators will also expand data to other high-penetrance GPV carriers, including PALB2, CDH1, PTEN, and TP53, for whom there is little-to-no data on outcomes following RRM.

Conditions

Breast Cancer Surgery

Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)
Description

The goal of this research study is to learn about the effects of the BBCSI course on the quality of life of Black breast cancer survivors. A community-based and peer-led Black Breast Cancer Survivors Intervention (BBCSI) course has been developed to help improve the quality of life of Black breast cancer survivors.

Conditions

Breast Cancer

Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.
Description

The purpose of this research study is to compare the efficacy and safety of EG1206A with Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant treatment for 18 weeks, followed by surgery and subsequent EG1206A or Perjeta in combination with trastuzumab, as adjuvant treatment for 36 weeks.

Conditions

Early Breast Cancer

Maximizing Energy and Reducing Fatigue in Breast Cancer Survivors
Description

This study is testing a program called Maximizing Energy to see if it can help women who have finished breast cancer treatment manage their fatigue. The study has two main goals: 1. Check if the program can be successfully delivered - Researchers will see if women are willing to join and stay in the study, if they follow the program, and if they find it helpful. 2. See if the program works - Researchers will compare Maximizing Energy to a general health education program to see which one helps reduce cancer-related fatigue better. Participant will: 1. Take tests to see if they qualify and to measure their fatigue. 2. Be randomized to receive Maximizing Energy or Health Education Interventions for 6 sessions over the internet 3. After the sessions and again one month later, repeat some tests to see if their fatigue has improved.

Conditions

Breast Cancer Survivor, Cancer Related Fatigue