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Breast Cancer clinical trials

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NCT ID: NCT04846972 Not yet recruiting - Breast Cancer Clinical Trials

Facilitate and Sustain Return to Work After Breast Cancer

FASTRACS-RCT
Start date: April 2021
Phase:
Study type: Observational

Breast cancer is the most frequent cancer in women in France, with an estimated 50,000 new cases each year. Prognosis is good, with a standardized survival rate of 85% at 5 years from diagnosis. Half of the women affected are of working age. Return to work after breast cancer faces barriers pertaining to the patients and their environment. There are social disparities in employment. Women with a lesser education and older women are at higher risk to lose their job. No intervention, to date, has demonstrated its effectiveness to facilitate return to work and reduce social disparities in employment after breast cancer. Current limitations of the interventions are to be over-medicalized and hospital-centered, to lack of theoretical foundations, and to be at risk of implementation failure. In a previous phase of the FASTRACS project, an intersectoral Community Advisory Board involving the different categories of stakeholders was launched to perform a needs analysis and build the logic model of the FASTRACS intervention with the Intervention Mapping protocol. The main objective of the FASTRACS intervention is to facilitate sustained return to work (RTW) after breast cancer. Secondary objectives are to improve work-related quality of life and to decrease social disparities in employment after breast cancer. Eligible patients are women: (1) aged between 18 and 55 years; (2) in paid employment; (3) diagnosed with a locally invasive non-metastatic first breast cancer (4) treated by surgery and chemotherapy in an adjuvant or neoadjuvant situation. Recruitment will take place in six investigating centres (centre hospitalier Lyon Sud, hôpital de la Croix-Rousse, hôpital femme-mère-enfant, centre Léon Bérard, hôpital Jean Mermoz, Clinique Charcot), after surgery and before the beginning of the chemotherapy. Women will be randomized between 2 groups (intervention vs control) with a stratification on the including centre, age, and socioprofessional category. The intervention is founded on a multilevel logic model addressing the social determinants of health. It is composed of 4 successive steps during which 4 tools will be used. The first step involves an interview at the end of chemotherapy with a nurse, during which the patient is given a guide to returning to work. The second step is a transitional consultation in the month following the end of radiotherapy (or chemotherapy for patients without radiotherapy), with the general practitioner (GP), with a checklist designed to individualise the patient's care. The third step is a pre-RTW visit to the occupational physician (OP) at a time deemed appropriate by the patient and her GP, with a checklist to facilitate the accomodation of the workstation and the job retention strategy. The fourth and final step will only occur for patients who have not returned to work 10 months after inclusion, and will involve an interview with an OP specialised in return-to-work (RTW) coordination. The last tool is an employer's guide that will be given by the patient to her OP and her manager, with practical advice for managers and colleagues to facilitate the RTW process. The evaluation of the intervention will be performed with mixed-methods by a realist randomized controlled trial including 210 patients in each group. For the effect evaluation, the primary outcome is a composite endpoint including: (a) a sustained return to work 12 months after oncological treatments (OT) ; and (b) the number of days on sick leave 12 months after oncological treatments. Secondary outcomes will include the patients' perspective (quality of life, anxiety, depression, RTW self-efficacy, social support, physical activity, work role functioning, work conditions), process outcomes (transition visit with the GP, pre RTW visit with the OP, other visits), and implementation outcomes (reach and use of the intervention tools). Expected public health impact: Provided it is acceptable, effective and sustainable, the innovative intervention developed in this project is likely to decrease the impact of breast cancer on employment, and to decrease social disparities in employment after breast cancer. According to the mechanisms activated in each context under study (centres, workplaces), it could be scaled-up but also adapted to fit the needs of patients with other cancers or other chronic health conditions.

NCT ID: NCT04843865 Not yet recruiting - Breast Cancer Clinical Trials

A Systemic Approach to Study the Traditional Chinese Medicine as an Adjuvant Treatment in Breast Cancer Patients

Start date: June 2021
Phase: N/A
Study type: Interventional

Chinese herbs can alleviates the side effects caused by conventional treatment in breast cancer patients and affects the syndrome element differentiation by altering the specific set of proteomes at specific time point of treatment.

NCT ID: NCT04843358 Not yet recruiting - Breast Cancer Clinical Trials

Efficacy of Expressive Writing on Quality of Life Among Breast Cancer Survivors in Oman: A Double Blind Randomized Controlled Trail

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

Background Breast cancer is the most common cancer affecting women globally. Additionally, it is the most common cause of cancer mortality among women. Internationally, breast cancer is the most frequently diagnosed cancer among women in 140 of 184 countries. Global registry surveys also demonstrate that the incidence of breast cancer will increase by 46% and affect more than 3,059,829 people by 2040. The rate of breast cancer deaths will increase by 58.3% and affect more than 356,225 women. Psychologically, it has been shown that emotional suppression experienced by some women with breast cancer is highly predictive of low quality of life and psycho-somatic morbidities during the process of treatment. Such attitude towards emotional suppression is thriving well in Arab societies where somatizing, as opposed to psychologizing, distress is prevailing proclivity. Expressive writing may provide a tool to meet such need. Taken together and given the lack of any study exploring EW effect of Quality of life in women with breast cancer. The current study aims to examine the impact of expressive writing on quality of life in a randomized controlled trial among cancer survivor in Oman. Hypothesis The primary hypothesis states that compared to writing about neutral topic, expressive writing intervention will lead to a better improvement in quality of life among breast cancer patients after two months of the intervention. Objectives To assess the efficacy of 3 sessions EWI versus Writing about neutral topic, on Quality of life of Breast Cancer Survivors at 1- and 2-month post intervention. Method This study is a multicenter, prospective, double blind, parallel RCT with a 2-month follow-up and will be carried out at Oman's comprehensive cancer care & research center and Sultan Qaboos University Hospital, Muscat, Oman. Sixty four participants will be randomized to 3 sessions EWI group or neutral topic writing group, using a fixed randomization schedule allocating participant between the two intervention arms in a 1:1 ratio.

NCT ID: NCT04842409 Not yet recruiting - Breast Cancer Clinical Trials

Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery

SAFE-FORWARD
Start date: May 2021
Phase:
Study type: Observational

SAFE-FORWARD is an observational prospective cohort study. Patient population included both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy is allowed. Main exclusion criteria are mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost. All enrolled patients will be prospectively monitored for 12 months, receiving a complex cardiological assessment before radiation therapy (RT) start (baseline), and at 2-, 6-, and 12-month after RT end of treatment. Both acute- , defined as adverse events recorded within the first 90 days since RT start, and early-late toxicity, will be scored according to EORTC (European Organisation for Research and Treatment of Cancer)/Radiation Therapy Oncology Group (RTOG) and CTCAE (v.5) scales. Patients will undergo six-monthly follow-up clinical visits for the first 5 years and annual follow-up visits thereafter up to 10 year, as per clinical local practice. Breast cosmesis will be evaluated through the use of BCCT.core tool and assessment of the health-related quality of life will be performed through the EORTC quality of life questionnaire (QLQ) C30 and BR45 modules questionnaires at baseline, at the end of RT treatment, at 2- and 6-month.

NCT ID: NCT04841148 Not yet recruiting - Breast Cancer Clinical Trials

Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer

PALAVY
Start date: May 2021
Phase: Phase 2
Study type: Interventional

This clinical trial will assess the safety and early efficacy of Hydroxychloroquine or Avelumab, with or without Palbociclib, in early-stage ER+ breast cancer patients who are found to harbor disseminated tumor cells (DTCs) in the bone marrow after definitive surgery and standard adjuvant therapy.

NCT ID: NCT04837677 Not yet recruiting - Breast Cancer Clinical Trials

A Study of PRT1419 in Patients With Advanced Solid Tumors

Start date: April 15, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia 1 (MCL1) inhibitor, in patients with advanced solid tumors. The purpose of this study is to define the dosing schedule, maximally tolerated dose and/or estimate the optimal biological dose to be used in subsequent development of PRT1419.

NCT ID: NCT04837248 Not yet recruiting - Breast Cancer Clinical Trials

Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer

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

Breast cancer surgery usually results in reduced range of motion of the shoulder joint, weakness of the musculature and altered scapular kinematics during movement. These factors limit activities of daily living, so rehabilitation exercises help to restore function after shoulder surgery. Women with breast cancer often have a life conditioned by the sequelae or morbidity secondary to the treatment of the disease and, despite the high cure rate, many patients are unable to regain their initial quality of life. Cancer therapies can leave physical, psychological and psychosocial sequelae, which may manifest themselves or persist even years after the end of treatment. For all these reasons, patients who have undergone cancer treatment need physical rehabilitation as well as psychological and social care to support them in their new stage of life, and to optimise the rehabilitation programme, it is necessary to identify each patient's individual needs, The digital support proposed in this study enables the development of a physiotherapy programme for patients with breast cancer in a situation of health crisis, which includes providing assistance, information, accompaniment, help and treatment to these patients in a comprehensive way, based on the biopsychosocial model.

NCT ID: NCT04837209 Not yet recruiting - Breast Cancer Clinical Trials

Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer

NADiR
Start date: April 2021
Phase: Phase 2
Study type: Interventional

This research study is looking to see whether the combination of Dostarlimab and Niraparib plus Radiation Therapy (RT) is safe and effective in participants with metastatic triple negative breast cancer. The names of the study treatment involved in this study are: - Dostarlimab - Niraparib - Radiation Therapy (RT), which is given per standard of care.

NCT ID: NCT04836520 Not yet recruiting - Breast Cancer Clinical Trials

SHR6390 Combined With Anastrozole for Preoperative Treatment of Breast Cancer.

Start date: April 30, 2021
Phase: Phase 2
Study type: Interventional

The study is being conducted to assess effect of SHR6390 combined with anastrozole on proliferation of HR-positive HER2-negative breast cancer tumor cells before surgery.

NCT ID: NCT04827459 Not yet recruiting - Breast Cancer Clinical Trials

Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors

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

This clinical trial will evaluate the adherence, usefulness, satisfaction and effect size for the Sleep Coach app as an intervention for insomnia in 30 adult post-treatment cancer survivors.