Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients With Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial
The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, [18F]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS). So as to decrease the edema of upper arm, and finally improve the quality of life of the patients.
NCT05935150 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05935150/
The Impact of Lymphedema Severity on Shoulder Joint Function and Muscle Activation Patterns in Breast Cancer Survivors: A Cross-Sectional Study
Breast cancer-related lymphedema (BCRL) is a common complication affecting the upper extremity following breast cancer treatment. This study aims to investigate the relationship between lymphedema severity and shoulder joint function and muscle activation patterns in breast cancer survivors.
NCT05934695 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT05934695/
A Prospective Registry Study to Evaluate Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
The purpose of this study is to evaluate clinical outcomes and adverse events of salvage treatment for locoregional recurrence of breast cancer. The main questions it aims to answer are: - Clinical outcomes after salvage treatment for locoregional recurrence - Adverse events and quality of life after salvage treatment for locoregional recurrence - Patient characteristics and treatment specifics which are related to the clinical outcomes and/or adverse events - Molecular signature associated with treatment resistance Participants will be assessed by multi-dimensional methods during and after radiation therapy: - Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination - Assessment for the adverse events according to CTCAE version 5.0 - Assessment for the molecular signature using residual tissue after pathologic diagnosis - Assessment for the quality of life using questionnaires (BREAST-Q)
NCT05933733 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05933733/
Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
NCT05933395 — Advanced Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/advanced-breast-cancer/NCT05933395/
Milademetan and Fulvestrant in GATA3-mutant, ER-positive, HER2-negative Advanced or Metastatic Breast Cancer Patients: a Multicenter Phase II Trial
This is a single arm, multicentric phase II study of milademetan plus fulvestrant in patients with ER+, HER2- ABC harboring GATA3 mutation(s) in the tumor and/or in ctDNA who have progressed on or after prior treatments including a CDK4/6 inhibitor. Frameshift or truncating GATA3 mutations will be identified by next generation sequencing (NGS) performed on either tissue or circulating DNA. Given the well-known safety profile of fulvestrant and the absence of significant toxicity expected from the association of fulvestrant and milademetan, a safety run-in is planned. During the course of the study, the Steering Committee will specifically review the occurrence of toxicities defined as DLTs in the safety run-in.
NCT05932667 — Advanced or Metastatic Breast Cancer
Status: Terminated
http://inclinicaltrials.com/advanced-or-metastatic-breast-cancer/NCT05932667/
Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration. Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks. Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality. Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.
NCT05931874 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05931874/
Using a SMART Design to Evaluate Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors
This clinical trial evaluates a remotely delivered, culturally tailored weight loss interventions in Latina breast cancer (BC) survivors. Cancer is the leading cause of death among Latinos, and among Latinas, BC is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer BC outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina BC survivors. The development of an adaptive program that provides survivors the support they need, as opposed to what is typically available, is essential to reducing persistent inequities in cancer survivorship.
NCT05930483 — Anatomic Stage III Breast Cancer AJCC v8
Status: Not yet recruiting
http://inclinicaltrials.com/anatomic-stage-iii-breast-cancer-ajcc-v8/NCT05930483/
Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
NCT05929768 — Anatomic Stage II Breast Cancer AJCC v8
Status: Recruiting
http://inclinicaltrials.com/anatomic-stage-ii-breast-cancer-ajcc-v8/NCT05929768/
Effects of Cryotherapy on Objective and Subjective Symptoms of Taxane-Induced Neuropathy in Patients With Early Breast Cancer: A National, Multicenter, Prospective, Randomized, Controlled Trial
Due to well-proven survival benefit, paclitaxel and other taxane-based chemotherapies are first-line agents for both the adjuvant and neoadjuvant treatment of early stage breast cancer. Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and disabling side effect of taxane anticancer agents. No established strategy exists for CIPN prevention. This study is designed to assess the efficacy and safety of cryotherapy for the prevention of paclitaxel-induced peripheral neuropathy in patients with breast cancer in a prospective randomized controlled trial.
NCT05928429 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05928429/
Phase I/II Clinical Study to Evaluate the Safety, Tolerance, Efficacy and Pharmacokinetics of TFX06 Tablet in ER Positive, HER Negative Locally Advanced or Metastatic Breast Cancer.
A Phase 1/2 Dose Escalation and Expansion Study of TFX06 tablet Alone in Women with ER Positive, HER2 Negative Advanced Breast Cancer
NCT05927779 — Metastatic Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/metastatic-breast-cancer/NCT05927779/