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Breast Neoplasm Female clinical trials

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NCT ID: NCT05417516 Recruiting - Radiotherapy Clinical Trials

A Randomized Trial of Five Fraction Partial Breast Irradiation

Start date: November 20, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

NCT ID: NCT05277935 Recruiting - Quality of Life Clinical Trials

Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib

WEFITTER
Start date: April 22, 2022
Phase: N/A
Study type: Interventional

Combining a fitness tracker technology with real-time patient-reported outcome monitoring associated with interventions through a health care app is a novel strategy to evaluate metastatic breast cancer patients using Palbociclib and endocrine treatment.

NCT ID: NCT05244382 Recruiting - Neoplasm Metastasis Clinical Trials

Overcome, a Program of Therapeutic Exercise and Functional Recovery to Improve the Functional Capacity of Women With Breast Cancer and Bone Metastases

Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The research to be carried out is aimed at patients with metastatic breast cancer, specifically bone metastases. These patients will be recruited from two hospitals in Granada, provided they meet the established inclusion criteria. With this study, it is pretend to demonstrate the benefits of a program of therapeutic exercise and functional recovery of motor control with ultrasound feedback for the improvement of the functional capacity of the women eligible to participate in the study, as well as a positive impact on the quality of life of the patients other than their survival. The effect of the Overcome program will be compared with the usual treatment in this type of pathology. To do this, a pre-intervention evaluation and another at the end of the evaluation of the variables to be measured, such as functional capacity, will be carried out. In addition other evaluation will be carried out, after 6 months to assess the long-term effects. In addition to the three main variables such as functional capacity and quality of life, another relationship of secondary variables will be studied, such as physical state, body composition or pain threshold, among others. This study in its entirety will be carried out by the "Oncology Patient Support Unit - Take Care" in the hands of a multidisciplinary team, carrying out the intervention protocolized by physiotherapists and occupational therapists.

NCT ID: NCT05140655 Recruiting - Clinical trials for Breast Neoplasm Female

Effectiveness and Safety of Fulvestrant in Postmenopausal Women With Advanced Breast Cancer HR+, HER2-

Start date: April 19, 2021
Phase:
Study type: Observational

A phase IV, single arm study will be performed in postmenopausal women with locally advanced or metastatic breast cancer. All patients included will receive fulvestrant from Dr. Reddy's Laboratories, in accordance with local practice and the regulatory authorization of the drug in Colombia. This study will be carried out for 1 year and approximately 40 patients will be included in 2 research centers selected for its conduct. Patients who meet the inclusion criteria and who do not have to be discarded from entering the study due to meeting any of the exclusion criteria, will be evaluated to determine the effectiveness and tolerability of the administration of Dr. Reddy's fulvestrant at a dose of 500 mg / month plus an additional indicated dose 14 days after the initial dose, for 12 months of follow-up or until disease progression or the appearance of unacceptable toxicity. The assessment of tolerability will be carried out based on the collection of data related to adverse events from the first dose administered.

NCT ID: NCT05075512 Recruiting - Clinical trials for Breast Neoplasm Female

The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer

Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops. Nowadays, various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality. Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR, FGFR, PDGFR, c-KIT, c-MET and RET. Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer. This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy.

NCT ID: NCT05071105 Recruiting - Clinical trials for Breast Neoplasm Female

SBRT in Early Breast Cancer in Elderly Women

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

Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment. In the United Kingdom it is estimated that over 40% of elderly women do not receive surgery for their breast cancer, and that their primary treatment is hormonal only, the so-called primary endocrinotherapy. In Italy the recent AIOM guidelines of 2019 exclude, in patients with hormone-sensitive disease and age older than 70, the omission of surgery in favor of hormone therapy alone, thus underlining the importance of a treatment local. However, there are currently no local treatments that could in any way effectively control the primary tumor. In recent years, SRT has widely found space as a therapeutic alternative in patients not fit for surgery. Stereotactic Radiotherapy is a non-invasive treatment with ablative intent obtained with highly focused high intensity fields for a few fractions (generally 1-5). It is the standard treatment for surgically inoperable lung cancers, and is also used in the treatment of liver metastases, intermediate-risk prostate cancer and locally advanced pancreatic cancers. The applications of stereotactic treatment in breast cancer are limited to the neoadjuvant and adjuvant setting. Against this backgroung, in elderly patients with localized breast cancer candidates for hormonal therapy and non-fit for surgery due to age or comorbidity, a SBRT could more effectively control local disease, not excluding local treatment rather than in itself it is considered very important.

NCT ID: NCT05027321 Recruiting - Clinical trials for Breast Neoplasm Female

Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies

Start date: October 11, 2022
Phase: N/A
Study type: Interventional

The incidence of breast cancer and its mortality are reduced thanks in particular to early detection. Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act. Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination. Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management. However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.

NCT ID: NCT04927130 Recruiting - Clinical trials for Breast Neoplasm Female

Retrospective Comparative in Vitro Case-controlled Study of the Liquid Biopsy Test System in Women With Breast Cancer

Start date: June 16, 2021
Phase:
Study type: Observational

Proof of Concept retrospective study. Women who have the diagnosis Breast Cancer ( confirmed by biopsy) will donate a blood samples. Tubes with blood will be transferred to the Sponsors Laboratory and ARNA Breast Test will be performed. The result of test will be compared with the biopsy result for each person.

NCT ID: NCT04815083 Recruiting - Breast Cancer Clinical Trials

Fluorescence Imaging of Carcinoma During Breast Conserving Surgery

Start date: April 27, 2021
Phase: Phase 3
Study type: Interventional

Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the cancer while conserving as much of the surrounding healthy tissue as possible. Current methods do not allow surgeons to determine the completeness of surgical resection in real-time. This often results in the need for a second surgical procedure, or in some cases more than two surgical procedures in order to have confidence that all cancer has been removed. This Phase 3 study will evaluate the safety and efficacy of the fluorescent imaging agent PD G 506 A for the real-time visualization of cancer during standard of care breast conserving surgery. PD G 506 A is an investigational drug which is converted in the body into a fluorescent molecule that accumulates in cancer cells. Patients receiving PD G 506 A will undergo standard of care breast conserving surgery followed by fluorescence imaging and removal of any potentially cancerous tissue left behind in the surgical cavity.

NCT ID: NCT04456855 Recruiting - Surgery Clinical Trials

Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients

SYSBTC-001
Start date: September 1, 2019
Phase:
Study type: Observational

Current guidelines lack definitive evidences about the relative benefits of locoregional surgery for the primary tumor in de novo stage IV breast cancer. The aim of this study (SYSBTC-001) was to investigate the role of locoregional surgery for primary tumor in de novo stage IV breast cancer.