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Breast Cancer clinical trials

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NCT ID: NCT05303675 Recruiting - Clinical trials for Breast Cancer Female

The Effect of Arm Exercises on Arm Oedema After Breast Cancer Surgery

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

In order to prevent lymphedema after breast surgery, patients are advised to know the risk factors for lymphedema and to avoid situations that may cause lymphedema, to perform active and passive arm exercises, to evaluate the affected area for lymphedema, to perform self-care and this should be under the self-management of the patients. Investigators think that this study will have a positive effect on the literature since there are no studies on risk scoring, the combined use of training and exercises to strengthen self-care skills in preventing the development of breast cancer-associated lymphedema. From this point of view, the study was planned as a randomized controlled experiment to examine the effects of preoperative lymphedema scoring and postoperative progressive upper extremity exercises on upper extremity function and self-care in women with breast cancer.

NCT ID: NCT05302778 Recruiting - Breast Cancer Clinical Trials

Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer

HERMIONE-10
Start date: March 22, 2021
Phase:
Study type: Observational

Multicenter, retrospective and prospective, cohort, observational study evaluating the clinical efficacy and tolerability of Eribulin as second-line treatment in accordance with the indications authorized by AIFA in patients with triple negative advanced breast cancer in a real world setting.

NCT ID: NCT05302336 Recruiting - Breast Cancer Clinical Trials

AC vs TC in Patients With HR-positive, HER2-negative Early Breast Cancer

Start date: May 1, 2022
Phase: Phase 4
Study type: Interventional

Anthracycline-paclitaxel sequential combination therapy is the standard regimen for perioperative chemotherapy in breast cancer. The strategy of perioperative chemotherapy is based on breast cancer subtype, i.e. choice of chemotherapy regimen and hormone receptor (HR) [estrogen receptor and/or progesterone receptor], human epidermal growth factor receptor 2 (HER2) related. Although HR-positive breast cancer has a better prognosis than other subtypes, standard chemotherapy for HR-positive breast cancer has not been established. The American Oncology Research Trial 9735 demonstrated that docetaxel + cyclophosphamide (TC) produced better results than doxorubicin + cyclophosphamide (AC) in adjuvant breast cancer treatment. However, the enrolled subjects of the 9735 trial did not strictly limit the tumor size, and the tumor size of some patients was greater than 5 cm; the hormone status of the patients was not limited, about 1/3 of the patients were ER negative, and the HER-2 status of the patients was not limited; 9735 Half of the trial's enrolled population had axillary lymph node metastases. From a large number of clinical studies, it has been found that the patient's tumor size, ER negative, HER-2 positive, lymph node metastasis and other factors are risk factors for breast cancer recurrence and metastasis after surgery. Therefore, for HR-positive, HER-2-negative early breast cancer patients, whether the TC regimen is superior to the AC regimen remains uncertain. The current CSCO breast cancer treatment still recommends the AC regimen as one of the options for adjuvant breast cancer treatment. Other studies have shown a benefit of anthracyclines in high-risk HR-positive disease, and TC is a suitable option for lower risk. The TC regimen had a higher incidence of myelosuppression and allergy than the AC regimen.

NCT ID: NCT05301881 Recruiting - Metastatic Cancer Clinical Trials

COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study

COSMO
Start date: April 17, 2023
Phase: Phase 2
Study type: Interventional

Patients with oligoprogression of metastatic breast cancer during palliative treatment that is amenable to local therapy will be included. The local ablative therapy (LAT) may consist of stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy, surgery or radiofrequency ablation (RFA).

NCT ID: NCT05301114 Recruiting - Breast Cancer Clinical Trials

Social Risk Factors and Discrimination in Cancer Survivorship

Start date: May 5, 2022
Phase: N/A
Study type: Interventional

The objective of the proposed study is to scale social risk factor screening and referral for cancer survivors and to solidify information exchange between clinical and community settings in order to improve survivor health and well-being. This will be completed through three primary aims: 1) To ascertain workflow and map community resources needed to facilitate social risk factor screening and referral for breast and prostate cancer survivors in Washington, District of Columbia. 2) To determine impact of Community Health Worker (CHW) support on Black breast and prostate cancer survivor health and wellbeing as measured through quality of life (QOL) and social connection. 3) To determine impact of anti-racism training for staff and clinicians at three cancer centers on patient-reported discrimination.

NCT ID: NCT05300464 Recruiting - Breast Cancer Clinical Trials

A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection

Start date: January 7, 2023
Phase: N/A
Study type: Interventional

This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions. MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (<1mW) microwave. The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position. MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.

NCT ID: NCT05298605 Recruiting - Clinical trials for Breast Cancer Female

Faith in Action! A Church-Based Navigation Model to Increase Breast Cancer Screening in Korean Women

Start date: July 16, 2022
Phase: N/A
Study type: Interventional

The purpose of this research is to develop a culturally adapted "Faith in Action!" curriculum to train lay health navigators to provide breast cancer screening navigation to Korean American women within faith-based settings and evaluate whether the culturally adapted "Faith in Action!" curriculum increases adherence to breast cancer screening guidelines among Korean American women within faith-based settings in Los Angeles, California. The primary research procedures include trainings and key informant interviews with lay health navigators in faith-based settings followed by a cluster randomized trial to evaluate the intervention.

NCT ID: NCT05297773 Recruiting - Breast Cancer Clinical Trials

Resistance vs. Aerobic Training on Breast Cancer Patients Undergoing Neoadjuvant Treatment

NEO-Program
Start date: December 16, 2022
Phase: N/A
Study type: Interventional

A recent consensus study suggested that understanding the impact of exercise on the tumor microenvironment and therapy effectiveness is paramount and should be considered as a research priority. Therefore, the research team intends to address some of the scientific challenges proposed, which represent clear gaps in the current knowledge. The investigators propose a randomized controlled trial conducted during all neoadjuvant treatment duration that aims to evaluate and compare the effects of two different exercise protocols (aerobic and resistance training) against a relaxation control group on Ki-67% changes as the main outcome in breast cancer patients. Secondary outcomes will be body composition; resting metabolic rate; physical fitness; quality of life, fatigue, depression/anxiety; accelerometry data (physical activity levels, sedentary time); sleep quality; tumor biology (size, hypoxia, and immune profile); glycemic, lipid, and inflammatory profile. This project will help not only researchers with the design of future exercise intervention protocols but will also help exercise physiologists in the decision-making process when defining training programs. Moreover, the investigators expect that this research program will encourage more cancer patients to exercise. The team expects that patients with breast cancer engaging in structured exercise will show a more marked decrease in Ki-67, tumor size, and hypoxia and increase the tumor-infiltrating lymphocytes (TILs) compared to controls. The investigators anticipate a more noticeable decrease in the preoperative endocrine prognostic index (PEPI) score and in the Residual Breast Cancer (RCB) in both training groups (respectively with hormonal and chemotherapy). Also, frequent declines in physical fitness are expected to be mitigated in exercisers. It is hypothesize that aerobic training will ameliorate cardiorespiratory fitness and fat mass, while the effects of resistance training will be more relevant for muscle strength, muscle mass, and bone health. Both exercise groups will show greater improvements in quality of life, fatigue, depression, anxiety, and sleep quality. Regarding glycemic, lipid, and inflammatory profiles, the investigators expect to see more favorable changes in both training groups, with a more evident decrease in fasting glucose and insulin, HbA1c%, total and LDL-cholesterol, and triglycerides, and the increase in HDL-cholesterol. The increase in C-reactive protein (CRP), tumor necrosis factor -α (TNF-α), interleukin-6 (IL-6), IL-8, IL-1β, IL-1ra, and insulin-like growth factor-1 (IGF-1) and the decrease in brain-derived neutrotophic factor (BDNF), IL-12p70, IL-10, oncostatin M will be smaller in exercise groups.

NCT ID: NCT05297617 Recruiting - Breast Cancer Clinical Trials

Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk

LESS
Start date: October 12, 2022
Phase: Phase 2
Study type: Interventional

Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer, but there is no consensus on its duration in low-risk tumours and especially in postmenopausal women. Adjuvant endocrine therapy (ET) is associated with substantial side effects and long-term decreased quality of life. Moreover, while it has been shown that ET provides a real benefit in reducing the relapse rate over time, the deterioration in quality of life may also have a negative effect on patient adherence to treatment. It is therefore important to offer treatment to women with low-risk cancer less intensive treatment strategies. If recent trials tested longer durations as compared to 5 years for high-risk cancers, older trials have tested shorter durations. The 5-year duration appeared at that time as the gold standard because of optimal benefit-risk ratios of tamoxifen among high-risk patients. However shorter treatments of 2-3 years were already associated with substantial benefits and may be enough for very low risk patients.

NCT ID: NCT05297591 Recruiting - Breast Cancer Clinical Trials

Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment

UPLIFT-BC
Start date: April 26, 2022
Phase:
Study type: Observational

Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment. The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment. There is a need to rethink the follow-up strategy (besides the treatment of the cancer itself) and develop a clinical care pathway consisting of multifactorial screening instruments to identify women and men who are in need of extra rehabilitation efforts and specific rehabilitation goals to alleviate symptoms and side effects experienced by breast cancer survivors. This clinical care pathway should cover all aspects of the International Classification of Function, Disease and Health (ICF), a biopsychosocial framework that conceptualizes a person's level of functioning and bodily structures, activity and participation and contextual factors (including personal and environmental factors). The present study aims to identify the factors, during and after breast cancer treatment, contributing to persistent Upper Limb (UL) dysfunctions.