View clinical trials related to Breast Neoplasms.
Filter by:This is a multi-center, observational study designed to explore the regulatory mechanism of palbociclib correlative pathways in therapeutic process of breast cancer, employing next generation sequencing (NGS) on DNA and RNA. This study also monitor the clonal evolution of genes by tracing the ctDNA.
Neoadjuvant chemotherapy (NAC) is common practice in the primary treatment of breast cancer, leading to a complete pathologic remission (pCR) of the tumor in more than 50% in aggressive tumor types. As NAC induces different response patterns, radiologic imaging is not sufficiently accurate in predicting residual disease. Because of this uncertainty, surgery is so far the only valid option to either ascertain complete response or to remove the complete residual disease. Vacuum-assisted biopsy (VAB) with the possibility of obtaining tissue of the former tumor center could contribute more reliably to detect any residual tumor or respectively, rule out residual disease. Ultrasound (US) or mammographically (MG) guided VAB will be used in this trial in order to detect residual tumor lesions in patients with radiological complete response (rCR) after NAC. The investigators will evaluate the diagnostic accuracy of the post-NAC VAB sample in comparison to the sample obtained in open surgery.
This is a multicenter hospital-based prospective cohort study conducted in institutions with known expertise in performing oocytes/embryo freezing for fertility preservation. The study aims at refining the understanding of the efficacy and safety of controlled ovarian stimulation with or without letrozole in young women with newly diagnosed breast cancer who are candidates to receive (neo)adjuvant chemotherapy.
A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY.
The treatment of breast cancer is determined by its 'receptor (or signal) status'. Receptors are signals present on all cells and if abnormal can drive cancer growth. One of the signals that can drive breast cancer growth is the HER2 receptor/signal. One quarter of all breast cancers are found to have too many HER2 signals i.e. HER2-positive breast cancer. HER2 is a member of the HER-family which constitutes HER1,HER2,HER3,and HER4 signals. Currently, tests can identify breast cancers with too much HER2, from a biopsy, so a cancer doctor can prescribe anti-HER2 treatment to block these signals. These drugs have improved survival rates in HER2-positive breast cancer. Members of the HER family can also 'pair' with each other to activate signals that encourage cancer growth. For example, HER3 naturally 'pairs' with HER2. Though anti-cancer drugs have been developed to target this pairing, the current method of patient selection is not developed to detect pairing of signals in tissue biopsies. A specialist imaging technique called FLIM-FRET (FLIM- Fluorescence Lifetime Imaging Microscopy; FRET- Forster resonance energy transfer) can identify signal pairing on cancer cells from tissue, and potentially, from blood samples. This study involves having blood tests while participants receive anti-HER2 treatment. The investigators will also seek permission to take samples of cancer tissue from the biopsies that were already carried out, e.g. at diagnosis. Some participants may need an additional biopsy, which will be discussed with participants prior to consent. This study will use the specialist FLIM-FRET technique to measure the signal pairing in tumour samples and blood samples. Investigators will measure if the levels of signal pairing from blood are the same as that from tissue, which could lead to bloods tests being used to select patients for anti-HER2 treatments, instead of invasive tissue biopsies. Changes in signal pairing may also help to predict if a cancer is becoming resistant to treatment.
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer.
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. Nevertheless, current practice standards commonly prescribe radiation dose and volume without regard to individual radiosensitivity. In that context, a normal tissue radiosensitivity test that includes a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial nomogram) was developed. Omission of radiotherapy has been suggested when luminal A tumor subtype is combined with clinical and pathologic factors defining a subgroup of patients with a low risk of ipsilateral breast recurrence. In this group, the benefits of radiotherapy are small [6]. Reduction of the breast irradiated volume is also a possibility that has been tested and published using IORT, brachytherapy or external beam radiotherapy. Hypofractionation has been adapted to breast cancer radiotherapy. Overall, all recent clinical trials [13, 14] showed only few late effects when hypofractionation was delivered to the whole breast (WB). These results reinforce the need of patients' selection using the NovaGray Breast® test. Our hypothesis is therefore that the different techniques (volume reduction or hypofractionation) as well as radiotherapy omission will significantly reduce grade ≥2 bf+ in a personalized approach (driven by a predictive assay of late effects) compared to WB hypofractionation in a selected population at low risk of breast recurrence. We would like to establish a prospective evaluation of daily practice including the individual radiosensitivity test to the decision of daily practice
BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4（CDK4）and CDK6 kinase activity. This Phase I study is a first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of oral BPI-1178 in patients with advanced solid tumors. The Phase IIa trial is designed to investigate the anti-tumor activity and safety of BPI-1178 in combination with endocrine therapy in patients with HR+/HER2-advanced breast cancer and to determine the dosing regimen for combination with endocrine therapy in a later confirmatory study.
This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.
In clinically node-positive (cN+) breast cancer, preoperative systemic therapy (PST) is common. With increasing rates of complete tumour eradication, there is a need for de-escalation of locoregional treatment in the interest of decreased morbidity. In order to individually adapt postoperative therapies, axillary staging is crucial. Axillary lymph node dissection (ALND) comes at a high risk of arm morbidity. There is extreme divergence in the use of less extensive staging methods, i.e. targeted lymph node biopsy (TLNB), sentinel node biopsy (SNB) or both (TAD), and in the use of subsequent locoregional treatment, since prospective data are largely lacking. The main purpose of the European INDAX trial is to implement de-escalated staging and evaluate which regional treatment, individually adapted to the response after PST, is oncologically safe but least harmful. Population: cN+ breast cancer patients receiving PST, recruited 2021-2025. Staging by TLNB, TAD or SNB. Intervention: Negative staging (ypN0, Randomisation A, N=1433): no regional treatment. Positive staging (ypN+, Randomisation B, N=1513): no ALND but regional radiotherapy (rRT). Control: Randomisation A: rRT only. Randomisation B: ALND plus rRT. Outcome: Invasive disease-free survival (non-inferiority), arm morbidity and quality of life. Drug tests in whole-tumour organoid cultures, algorithm-based digital image analysis and gene expression analysis are performed to improve response prediction, facilitate tailoring of PST and increase eradication rates.