View clinical trials related to Breast Neoplasms.
Filter by:The purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (SLN) using Indocyanine green (ICG). Moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of SLN during the surgery, and evaluate the diagnosis consistency of the AI technique and pathological examinations for lymph node with and without metastasis.
Evaluation of the diagnostic accuracy of Mammography in the morpho-structural analysis of mammographic images in breast cancer-diagnosed patients or patients in follow-up for breast cancer by extracting a number of features describing the texture and morphology of the lesions reported in the form of a structured report explicitly developed for the study. Correlation of the data obtained from evaluating the primary endpoint with the genetic/molecular analysis on liquid biopsy.
This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the imaging performance of 99mTc-MIRC213 in breast cancer patients. A single dose of 11.1-14.8Mega-Becquerel (MBq) per kilogram body weight 99mTc-MIRC213 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.
PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG in the same group of breast cancer patients.
This is a Phase 1b open-label, single arm, multicenter, study of ALRN-6924 as a chemoprotection agent in patients with TP53-mutated HER2- breast cancer (stages IIa to IIIb) receiving neoadjuvant or adjuvant chemotherapy with doxorubicin, docetaxel, and cyclophosphamide (TAC). Chemotherapy affects cells that are dividing, whether they are tumor cells or healthy cells (including, bone marrow cells, hair follicle cells, and epithelial cells lining the gastrointestinal tract). ALRN-6924 is designed to stop cell division in healthy cells but not in tumor cells because they have a mutation of the TP53 gene. When this happens, tumor cells will still be destroyed by the chemotherapy but healthy cells that are not dividing may be spared from chemotherapy damage and the patient should have less side effects.
This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.
Studies H0648g and M77001 confirmed that the combination of trastuzumab with taxanes significantly improved TTP and OS, establishing the status of trastuzumab combined with taxanes as first-line standard therapy.The CLEOPATRA and PUFFIN studies confirmed that trastuzumab combined with pertuzumab achieved PFS of 18.7 and 16.5 months, respectively, and became today 's first-line standard regimen for advanced HER2 + breast cancer. Pyrotinib acts on the intracellular segment of HER2 receptor and can inhibit tumor cell growth by covalently binding to the ATP binding site in the intracellular tyrosine kinase region and blocking the activation of downstream signaling pathways. The mechanism of action of the macromolecular drug trastuzumab combined with the small molecular drug pyrotinib dual-target in the treatment of HER2-positive breast cancer is complementary and has a synergistic anti-tumor effect. In 2022, the ESMO conference reported the results of a phase III trial of pyrotinib combined with trastuzumab combined with docetaxel in advanced HER2-positive breast cancer with an LBA, with the primary endpoint of investigator-assessed PFS.The results showed a significant 59% reduction in the risk of disease progression or death compared with 10.4 months in the trastuzumab plus docetaxel arm and 24.3 months in the pyrotinib arm. Inetetamab is a monoclonal antibody against the IV domain of the HER2 receptor with the same Fab segment as trastuzumab and different amino acid sequences from trastuzumab at positions 359 and 361 of the Fc segment heavy chain constant region, Antibody-dependent cell-mediated cytotoxicity (ADCC) was 1.11-fold higher than trastuzumab. PFS reached 11.1 months in the first-line subgroup analysis of the Phase III registration study of Inetetamab (HOPES study), which was similar to historical data from trastuzumab first-line treatment of HER2-positive metastatic breast cancer, with comparable safety. The results of this study contribute to further understanding the efficacy and safety of first-line treatment with Inetetamab Combined with Pyrotinib and Chemotherapy in HER2-positive recurrent/metastatic breast cancer patients.
This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced or metastatic cancer.
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
The aim of the present study is to verify the effects of a psychological-clinical intervention supported by the technique of expressive writing, on the post-operative course in terms of mental and physical health in patients undergoing surgical mastectomy treatment with post-oncological breast reconstruction. In particular, it is hypothesised that patients undergoing psychological, emotional and social well-being in the phase following surgical treatment, together with an improvement in the inflammatory profile and a possible change in the tryptophan/kynurenine ratio and cortisol. For this purpose, the recruited patients will be randomly divided into two groups. The first experimental group will consist of 10 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique who will carry out the psychological-clinical intervention focusing on expressive writing about their experience of the surgical treatment. The psychological-clinical intervention includes five interviews interspersed with three days of expressive writing by Pennebaker (1986). The writing task consists of writing about a traumatic experience or an event significant to the person, for a controlled period of time (usually 15 to 30 minutes) and on consecutive days (2 to 3 days). The second control group will consist of 10 patients with an indication for reconstruction using autologous tissues (DIEP, FALD) and 10 patients with an indication for reconstruction using the immediate prosthesis technique who will not undergo any kind of psychological-clinical intervention and will be able to apply for the latter at the end of the research. In order to verify the effectiveness of the psychological-clinical intervention, the patients will undergo a psychological evaluation (anxiety, depression, alexithymia, distress, resilience, hope for the future, quality of life, body image, psychological and affective experiences related to breast reconstruction) and a survey of physiological variables (inflammatory response, ratio tryptophan/kynurenine ratio and salivary cortisol) at the various times envisaged in the study: T0 (1 month pre-surgery mastectomy with breast reconstruction), T1(the day after the end of the psychological-clinical intervention), T2 (3 months post psychological-clinical intervention) and T3 (6 months post psychological-clinical intervention).