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Breast Neoplasms clinical trials

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NCT ID: NCT05522959 Recruiting - Breast Cancer Clinical Trials

Cardio-Oncology Rehabilitation Exercise

CORE
Start date: March 14, 2022
Phase:
Study type: Observational

Women with breast cancer who are referred to the cardiac rehabilitation program at the Toronto Rehabilitation Institute will be invited to enrol in this observational study. Participants will take part in an established 16-week multimodal cardiac rehabilitation program (HEALTh program) at Toronto Rehabilitation Institute and outcome measures will be assessed before and after program participation to determine the effectiveness of the program in improving cardio metabolic health. Change in VO₂peak will be assessed using Cardiopulmonary Exercise Test (CPET). Traditional cardiac risk factors, lifestyle behaviours, exercise adherence, health-related quality of life, and fatigue will also be assessed.

NCT ID: NCT05520723 Active, not recruiting - Breast Cancer Clinical Trials

Preventive stRategy for IMMU132-relatED AEs in TNBC - PRIMED

PRIMED
Start date: February 7, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial that is designed to improve the tolerance of sacituzumab govitecan in patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC), refractory to at least one, and no more than two, prior standard of care chemotherapy regimens in this setting that is not amenable to resection with curative intent. The goal of this study is to evaluate the safety of sacituzumab govitecan in combination with loperamide and G-CSF in pretreated patients with unresectable locally advanced or metastatic TNBC.

NCT ID: NCT05520515 Recruiting - Breast Cancer Clinical Trials

Water and Land-based Aerobic Training in Breast Cancer Survivors

WaterMama
Start date: December 19, 2022
Phase: N/A
Study type: Interventional

Background: Breast cancer is the type of cancer that mostly affects women in the world. Although physical and psychological side effects accompany cancer and the aggressiveness of the treatment, regular practice of physical exercise is considered a non-pharmacological tool to improve the quality of life of breast cancer survivors. The present study aims to evaluate the effects of aerobic training programs in aquatic and land environments plus a health education program, compared with a health education program alone, on cancer-related fatigue and other health-related outcomes in breast cancer survivors. Methods: The WaterMama trial is a randomized, single-blinded, three-arm, parallel, superiority trial. Forty-eight women, ≥18 years of age, who have completed primary treatment and been diagnosed with stage I-III breast cancer are recruited. Participants are randomly allocated on a 1:1:1 ratio to 12-week interventions of aerobic exercise training programs either on the aquatic or land environment two times per week plus health education, or an active-control group receiving health education intervention, once a week. Cancer-related fatigue (primary outcome), physical fitness (i.e., muscle strength of the knee extensors, muscle thickness and muscle quality of quadriceps, resting heart rate, maximum oxygen consumption, and performance in functional tests), mental health (i.e., depressive and anxiety symptoms), cognitive function, pain and quality of life are measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria. Discussion: The conceptual hypothesis is that both training programs plus health education positively affect cancer-related fatigue, physical fitness, mental health, cognitive function, pain, and quality of life compared to the health education group alone. Additionally, it is expected that the aquatic program plus health education to provide more significant effects on cancer-related fatigue and physical parameters due to its multi-component character, with a consequent greater positive impact on other investigated parameters in this group.

NCT ID: NCT05519670 Not yet recruiting - Breast Cancer Clinical Trials

A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr

CAPRICE
Start date: March 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study will be to combine oral capecitabine and oral niraparib such thz association may increase clinical benefits of PARP inhibitors in germline BRCA mutated HER2 negative advanced breast cancer patients.

NCT ID: NCT05519397 Completed - Breast Cancer Clinical Trials

Evaluation of the Role of Immune Checkpoints in Response to Breast Cancer Neoadjuvant Therapy

Start date: January 1, 2022
Phase:
Study type: Observational

Breast cancer is the most common type of cancer in women and the second most common cause of death after lung cancer. In epidemiological studies, its prevalence is 22-26%, and the mortality risk due to breast cancer is around 18%. It is known that the immune system has an important role in tumor development or tumor destruction. Recent studies have shown that tumor cells acquire escape mechanisms to escape host immunity in the tumor microenvironment. Studies have reported that immune checkpoints are elevated in many types of cancer and have a poor prognosis. Up or down regulation of immune checkpoints is observed to protect breast cancer cells from the anti-tumor responses of the immune system. There are also immune checkpoints found in plasma in soluble form, and the number of studies evaluating soluble immune checkpoints in cancers is very limited in the literature. Measurement of soluble immune control points is easier than those expressed on the surface, and many markers can be evaluated at the same time. There are very few studies in the literature evaluating soluble immune checkpoints in breast cancer. The aim of this study is to investigate the role of soluble immune checkpoints in predicting the response to neoadjuvant therapy in locally advanced breast cancers.

NCT ID: NCT05519059 Completed - Clinical trials for Advanced or Metastatic Breast Cancer

Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer

Start date: October 11, 2021
Phase: Phase 1
Study type: Interventional

This ia a multicenter, Single-Arm, Open-Label Phase I Clinical Study Evaluating the Safety and Tolerability of Pelareorep Combined with Paclitaxel Injection and the Intracorporal Process of Pelareorep in Chinese Patients with Advanced or Metastatic Breast Cancer.

NCT ID: NCT05514717 Recruiting - Clinical trials for HER2-positive Breast Cancer

A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2

Start date: January 24, 2023
Phase: Phase 1
Study type: Interventional

A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.

NCT ID: NCT05514054 Recruiting - Breast Neoplasms Clinical Trials

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

EMBER-4
Start date: October 4, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

NCT ID: NCT05512468 Recruiting - Breast Cancer Clinical Trials

Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).

NCT ID: NCT05512416 Not yet recruiting - Breast Cancer Clinical Trials

Neoadjuvant Dalpiciclib Plus Letrozole for HR+/HER2- Breast Cancer

Start date: August 2022
Phase: Phase 2
Study type: Interventional

In this single arm, open label, phase 2 trial, operable patients with stage IIB-III HR+/HER2- breast cancer will be enrolled and receive six cycles of adjuvant dalpiciclib plus letrozole. This study aims to assessed the biological effects and safety of dalpiciclib in combination with letrozole for HR+/HER2- breast cancer in the neoadjuvant setting.