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Showing 1-13 of 13 trials
NCT06954623
Breast cancer is the most common malignancy in women. Breast-conserving surgery (BCS) with adjuvant whole-breast irradiation (WBI) is currently the standard of care in the oncological treatment of primary breast cancer and offers an equivalent alternative to mastectomy. The primary aim of adjuvant radiotherapy (RT) is to improve local control and thus improve overall survival and breast cancer-specific mortality. However, nodal-negative women have a 10-year risk for local recurrences after RT in up to 15.6%. The management of ipsilateral breast cancer recurrence depends on the extent of tumor disease and staging results at the time of recurrence and mastectomy is currently the standard of care for previously irradiated patients. The application of particle therapy using proton beam therapy (PBT) represents an innovative radiotherapeutic technique for breast cancer patients. This trial will be conducted as a prospective single-arm phase II study in 20 patients with histologically proven invasive breast cancer recurrences with negative margins after repeat BCS and with an indication for local re-irradiation. Required time interval will be 1 year after previous RT to the ipsilateral breast. Patients will receive partial breast re-RT with proton beam therapy in 15 once daily fractions up to a total dose of 40.05 GyRBE. The primary endpoint is defined as the cumulative overall occurrence of acute / subacute skin toxicity grade ≥3 within 6 months after the start of re-RT.
NCT06449222
This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).
NCT06517212
This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk early breast cancer patients with obesity or overweight, inhibiting the growth and survival of micrometastatic disease and leading to clearance of tumor-informed circulating tumor DNA (ctDNA) and freedom from the development of metastatic disease.
NCT06774027
Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC) and hormone receptor positive/HER2 negative (HR+/HER2-) metastatic breast cancer (MBC), offering an effective new treatment strategy. Several outstanding questions drive the decision to use ADC drugs clinically. This is a prospective, multi-site observational study of patients with metastatic breast cancer (mBC) who are being treated with FDA-approved antibody drug conjugates (ADCs) as part of routine care and aims to collect real-world data to evaluate the impact of ADC treatment as part of routine care.
NCT06606730
OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study. The main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment, have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months. This research will also take into account patients tolerance to treatment and quality of life.
NCT06943313
Abnormal activation of the PI3K-AKT signaling pathway in breast cancer patients is closely associated with tumor progression. Phosphorylated AKT (p-AKT) serves as a key indicator of pathway activation. In this study, we utilize a novel probe, 68Ga-pAKTi, which enables precise targeting of tumor p-AKT expression levels to monitor PI3K-AKT pathway activation. The aim of this study is to evaluate the diagnostic accuracy of 68Ga-pAKTi PET/CT in detecting p-AKT expression in breast cancer and to compare its performance with that of 18F-FDG PET/CT. A total of 20 patients with breast cancer will be enrolled. Screening will be conducted within 14 days prior to administration of 68Ga-pAKTi (from Day -14 to Day -1). Subjects who meet all inclusion criteria and none of the exclusion criteria will receive an intravenous injection of 68Ga-pAKTi on Day 0, followed by PET/CT imaging. Biopsy/pathological results and conventional imaging findings will be followed up to validate the diagnostic efficacy of 68Ga-pAKTi PET/CT in accurately detecting p-AKT expression in breast cancer.
NCT06811870
The goal of the study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of breast cancer patients
NCT06825975
The goal of the study is to explore the efficacy and safety of hyperbaric oxygen therapy in the neoadjuvant treatment of triple-negative and HER2+ breast cancer patients
NCT06662864
This was a prospective survey conducted at a single site, the Rafaël Institute, France. Eligible patients were women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer and undergoing adjuvant endocrine therapy since at least 3 months. Patients reported outcomes were collected via telephone. Primary endpoint consisted in the global Pittsburgh Sleep Quality Index (PSQI). Secondary endpoints included evaluation of anxiety and depression (hospital anxiety and depression scale, HADS), pain (numeric rating scale), health related quality of life (EQ-5D-5L) and lifestyle habits (questionnaire designed for this study). Descriptive statistical analyses were performed with the intention to treat population. Sixty patients were included after providing oral informed consent. The PSQI evaluation of subjective sleep quality revealed a global score of 7.40. The majority of patients (73.3%) obtained a score \> 5. Among those, 50% obtained a score between 6 and 10, while 23.3% had a score between 11 and 15. In contrast, only 26.7% of patients were good sleepers with a score \<=5. Mean scores for anxiety and depression were 6.5 (+/- 3.8) and 3.3 (+/- 3.2) indicating non cases. The majority of patients (44; 73%) said to suffer from joint pain. In a matrix correlation test, the correlation index of PSQI with anxiety, depression and pain were +0.19, +0.28 and +0.44, respectively. The mean score in the EQ-5D-5L visual analogue scale was 63.0 (+/-13) for the entire sample. 44% of patients reported to use complementary medicine to help them feel better. The majority of patients with breast cancer undergoing endocrine therapy were considered poor sleepers. Pain was moderately correlated with sleep disorders while both anxiety and depression showed a weak correlation. Awareness and knowledge on integrative approaches to support and improve patients' outcomes remains low among breast cancer patients.
NCT06433804
This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre. This study was performed in line with STROCSS criteria. The following clinicopathological data was retrieved from the histopathological records- age, tumor size, nodal involvement, lymphovascular/ perineural invasion, and Bloom Richardson grading. Routine histopathological processing was done followed by immunohistochemical analysis for ER, PR, HER2, Ki67 and AR. All the cases were categorised into Luminal A, B, Her2 enriched and triple-negative breast cancer based on the surrogate molecular classification. Further, all the cases were categorised into HER2 negative (no staining or incomplete weak membrane staining in ≤10% tumor cells), HER2 3+ (complete membranous staining) and HER2 low (1-2+ staining without amplification on ISH) based on consensus of two pathology consultants. The present study aims to evaluate the clinicopathological parameters of the HER2 low breast cancers.
NCT01983501
The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.
NCT03667417
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
NCT00248911
Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.