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Breast Neoplasms clinical trials

View clinical trials related to Breast Neoplasms.

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NCT ID: NCT04866992 Completed - Clinical trials for Anatomic Stage II Breast Cancer AJCC v8

Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)

SPrNSM
Start date: February 1, 2020
Phase:
Study type: Observational

This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.

NCT ID: NCT04865549 Completed - Breast Cancer Clinical Trials

Sentinel Node After Neoadjuvancy In Node-Positive Breast Cancer

SANA
Start date: June 1, 2016
Phase: N/A
Study type: Interventional

The status of the axillary lymph nodes is one of the main prognostic factors in breast cancer (BC). SLNB is currently the standard staging method for patients with clinically node-negative (cN0) breast cancer. In patients with a positive SLN and in those with affected lymph nodes at the beginning (cN+), LND is the standard of treatment.

NCT ID: NCT04864405 Completed - Breast Cancer Clinical Trials

Evaluating the Dose Timing (Morning vs Evening) of Endocrine Therapy and Its Effects on Tolerability and Compliance

Start date: June 30, 2021
Phase: Phase 4
Study type: Interventional

Endocrine therapy is an established treatment for hormone receptor-positive breast cancer, but can cause significant side effects with deterioration in quality of life. The side effects of all forms of endocrine therapy are well recognized and can lead to treatment non-persistence or non-compliance. Chronotherapy, also called chronotherapeutics, is defined as the administration of a medication in coordination with circadian rhythm in order to minimize side effects and yield a greater efficacy. The investigators propose to perform a pragmatic, multi-centre, open-label, randomized clinical trial to establish the optimal timing (morning vs. evening) of administering endocrine therapy based on side effects and benefits in early stage breast cancer patients.

NCT ID: NCT04862663 Recruiting - Clinical trials for Locally Advanced (Inoperable) or Metastatic Breast Cancer

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

CAPItello-292
Start date: May 10, 2021
Phase: Phase 3
Study type: Interventional

A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

NCT ID: NCT04862585 Recruiting - Breast Carcinoma Clinical Trials

Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel

Start date: October 7, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This phase II/III trial investigates the difference in rates of infusion hypersensitivity reaction in patients with breast cancer who are receiving paclitaxel alone or in combination with other cancer drugs which require parenteral rescue medication after stopping standard pre-medications (dexamethasone, diphenhydramine, famotidine/cimetidine/ranitidine), compared to continuing premedications. Paclitaxel is a drug used to treat breast cancer, ovarian cancer, and autoimmune deficiency syndrome (AIDS)-related Kaposi sarcoma. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. However, there are side-effects and toxicities associated with repeat exposure to this pre-medication regimen. With prolonged use of paclitaxel, especially during weekly regimens, patients are exposed to repeat doses of drugs that prevent hypersensitivity reactions. Side effects include, but are not limited to, insomnia, gastritis, fluid retention, weight gain, mood changes and immune suppression. The information gained from this study may positively influence clinical practice and help researchers develop methods to safely stop pre-medications.

NCT ID: NCT04862195 Terminated - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

This is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (SaMD) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial) oncology usual care regimens for up to 10 weeks. Study population will consist of up to 553 participants with stage I-III breast cancer or stage I-III NSCLC. The primary endpoint is percent improvement in anxiety symptoms at Week 10 and secondary endpoints of percent improvement in depressive symptoms will be assessed at Week 12. An interim analysis for efficacy and futility will be conducted once 236 participants have completed the study.

NCT ID: NCT04862143 Terminated - Clinical trials for Advanced Breast Cancer

Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant

TELEPIK
Start date: March 8, 2022
Phase: Phase 2
Study type: Interventional

The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.

NCT ID: NCT04862078 Enrolling by invitation - Breast Cancer Clinical Trials

Shared Decision Making in Surveillance for Distant Metastasis in Breast Cancer

SMART-FU
Start date: July 6, 2021
Phase: N/A
Study type: Interventional

In this study, clinical impacts of shared decision making between physicians and patients in strategy of surveillance for asymptomatic patients who ended the primary treatments on quality of life would be investigated

NCT ID: NCT04861896 Completed - Quality of Life Clinical Trials

A Research Study for Latina Women With Breast Cancer

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the feasibility and preliminary efficacy of a psychosocial eHealth intervention designed to improve hormone therapy adherence among Hispanic/Latinx women with breast cancer. Our proposed secondary outcomes are health-related quality of life and self-efficacy in managing hormone therapy side effects. The intervention components include breast cancer knowledge, hormone/endocrine therapy knowledge, stress awareness and management, social support, and enhanced communication and intimacy skills. The intervention will be delivered via a Smartphone application over a 12-week period. All participants will receive the intervention application (described below). Aside from using the Smartphone application for the recommended 12 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), 6-week follow-up, and 12-week follow-up.

NCT ID: NCT04861220 Recruiting - Breast Neoplasm Clinical Trials

Surgical Pre-habilitation in Breast Cancer.

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The National Cancer Institute estimated 625 thousand new cases of cancer (excluding cases of non-melanoma skin cancer) in Brazil for each year between 2020-2022. In 2018, there were 2.1 million new cases of breast cancer in the world, being the first in the ranking of cancers in women. Practices in healthy eating and exercise can protect and / or decrease the risk of breast cancer and improve treatment results. Breast cancer treatments cause cardiovascular changes due to age-related factors, pre-existing chronic diseases and comorbidities such as obesity, smoking and dyslipidemia. Obesity is associated with the development of several types of cancer, including breast cancer. Therapies for breast cancer have a strong association with impaired cardiac function, ranging from permanent, transient cardiotoxic effects and changes in lipid metabolism. In addition to the cardiotoxic effects, the pathophysiology of cancer and treatment favor the appearance of muscle changes, such as sarcopenia. There is sufficient evidence to support that exercise improves fitness before, during and after the completion of cancer treatment. Pre-qualification in cancer treatment is an opportunity to increase physiological reserves before neoadjuvant therapies or surgery, with the intention of improving results and accelerating recovery. It can be composed of physical exercises, nutritional interventions, and psychosocial. Excess weight or depletion are factors that negatively influence surgical and cancer outcomes. In view of the evidence, the aim of this project is to evaluate the effectiveness of physical exercise in a surgical pre-habilitation program for women diagnosed with breast cancer undergoing cancer treatment with a curative therapeutic proposal at the National Cancer Institute in Rio de Janeiro. This is a randomized clinical trial, where patients will be randomly allocated to the Intervention Group and the Control Group. The patients in the intervention group will be instructed to practice physical exercises at home until the date of surgery and those in the control group will only be instructed to maintain their usual activities. All patients will be guided individually by a nutritionist with a view to a healthier nutritional status and control of comorbidities.