Precision Platform Study of HR+/ HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study)
The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had previously used CDK4/6 inhibitors.
NCT05594095 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05594095/
Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer.
The aim of this trial is to explore the real-world effectiveness and poteintial predictors in Chinese metastatic breast cancer patients.
NCT05594082 — Breast Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/breast-cancer/NCT05594082/
Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients
Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer patients will presumably produce comparable toxicity and disease control in comparison to 3 weeks schedule. The aim is to evaluate toxicity and disease control after implementation of accelerated hypofractionated 1 week chest wall irradiation in breast cancer patients.
NCT05591456 — Breast Cancer Radiotherapy
Status: Completed
http://inclinicaltrials.com/breast-cancer-radiotherapy/NCT05591456/
REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
REBECCA-1 is an observational study. Clinical research is undergoing a revolutionary change. The use of electronic patient records (EHR), digital registers, smartphones etc will create "real-world data" (RWD) that provides great opportunities for advancing clinical research, but so far this opportunity has been little exploited. The REBECCA -1 study will observe and monitor fatigue in breast cancer survivors. Investigators will use self reported questionnaires (PROM-data), blood tests and objective regulations like the REBECCCA -1 smart watch that will register amount of steps every day, leaving the house, visiting friends, cafes etc. There will be three observational arms; 1.high fatigue, 2. low fatigue and 3. a healthy control arm. After the patients have finished their treatment, they will receive the REBECCA smart watch, a REBECCA app on the smart phone and a REBECCA plus device on their computer, The next offend are also invited to report their evaluation through the same apps. The observational time will be 1 year and comparison between the subjective PROM data , the objective REBECCA watch and the biological samples will be obtained.
NCT05587777 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT05587777/
Ultra-hypofractionated Adjuvant Radiotherapy After Breast Conserving Surgery in Breast Cancer Patients
The present multicenter, retrospective and prospective observational study, aims to evaluate an ultra-hypofractionated whole breast irradiation schedule (WBI, 26 Gy in 5 fractions), in order to confirm literature data (FAST-F study) in the clinical practice. Patient population included women affected by early stage breast cancer (BC), both invasive and ductal carcinoma in situ, receiving ultra-hypofractionated WBI (with or without a tumor bed boost) after breast conserving surgery (BCS). Main exclusion criteria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed. The primary otcome is acute and chronic toxicity evaluation. Secondary outcomes are: overall servival (OS), disease-free survival (DFS), rates of local and loco-regional recurrences, distant metastasis occurrence, cosmetic outcome and quality of life (QoL) assessment. Acute and late toxicities will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0. Cosmetic assessment will be graded according to the Harvard scale. Frontal photographs of both breasts will be used to evaluate toxicity and cosmetic results. For QoL assessment the EORTC (European Organisation for Research and Treatment of Cancer), QLQ-C30 and EORTC-QLQ-BR23 questionnaires will be administered.
NCT05586256 — Female Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/female-breast-cancer/NCT05586256/
Effectiveness of C02 Microfractionated Laser in Conjunction With Topical Regenerative Therapy in the Management of Vulvo-vaginal Atrophy in Patients With a History of Breast Cancer. Randomized Experimental and Comparative Study.
The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.
NCT05585476 — Breast Cancer Female
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer-female/NCT05585476/
Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer: a Multicenter, Observational, Real-world Study
This study is a multi-center, observational, real-world study. We planned to recruit 420 HR+ locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions, completely following the physician 's clinical choice, to assess the efficacy and safety of dalpiciclib-containing regimens.
NCT05578053 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT05578053/
Peking University Cancer Hospital & Institute
This study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HR+/HER2+ brest cancer, providing more possible effective regimens for the survival benefit of these patients in clinical practice.
NCT05577442 — Breast Neoplasm Female
Status: Not yet recruiting
http://inclinicaltrials.com/breast-neoplasm-female/NCT05577442/
Sexual Quality of Life and Metastatic Breast Cancer
The study is composed of three paper self-questionnaires to be filled in by the patients included at distance (> 6 months) from their diagnosis of metastatic breast cancer, in order to limit the impact of the announcement on the filling out the questionnaires. After verification of the eligibility criteria, the medical oncologist will present the study to patients coming to the ICL for a follow-up consultation as part of their regular care. The patients will meet with a clinical research nurse so that she can explain the again and answer any questions they may have. She will also give the patients the questionnaires questionnaires and will give a presentation of the questions asked. After this meeting, the patients will be given sufficient time to reflect on, which may extend until their next visit to the ICL, in order to express, if they wish, their opposition to participating in the study. If she agrees to participate, the patient can then complete the questionnaires as well as the complementary questionnaire and place them in a closed envelope to be given to the clinical research nurse. The completion of the questionnaires will be completely anonymous. The data of those who object to the use of their data will be deleted from the database. After the completion of the questionnaires, and in order to allow a benefit for the patient, a semi-directive interview in the form of a teleconsultation with a psycho-oncologist and sexologist will be offered. The interviews are not mandatory. The time to fill in the self-questionnaires is estimated at 30 minutes and the semi-directive interview can last up to one hour. Finally, at the end of the study, as part of her subsequent care, each patient participating in the study will have the possibility to renew a teleconsultation with the psycho-oncologist and sexologist if she feels the need. As the subject of the study may generate personal questions and lead to a request for psychological and/or sexological care.
NCT05577156 — Breast Cancer
Status: Completed
http://inclinicaltrials.com/breast-cancer/NCT05577156/
Neoadjuvant Fluzoparib Combined With Camrelizumab in Germline BRCA-mutated HER2-negative Breast Cancer: An Open-label, Single-arm, Multicenter Trial
This study is an open-label, single-arm, multicenter clinical study. 94 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。
NCT05576389 — Germline BRCA-mutated HER2-negative Breast Cancer
Status: Enrolling by invitation
http://inclinicaltrials.com/germline-brca-mutated-her2-negative-breast-cancer/NCT05576389/