Second Line ERIbulin Followed by CApecitabine or the Reverse Sequence in HER2-negative Metastatic...
Metastatic Breast CancerGIM22-ERICA is a clinical trial investigating the efficacy of two different strategies in HER2 negative MBC treatment. The study will include MBC patients with histologically documented HER2 negative disease, who have progressed to one prior regimen for metastatic disease and are eligible for a second-line chemotherapy with either eribulin or capecitabine. This study design should answer to different questions: What is the correct placement of Eribulin in the context of a long term treatment strategy? Is an early use of Eribulin the best approach for MBC pts treatment? May early use of Eribulin impact on subsequent treatment outcomes? The correlated biomarkers analysis, evaluating angiogenic, epithelial and mesenchymal markers should confirm the results observed in preclinical studies ad support the clinical findings. Liquid biopsies and ctDNA evaluation could help to monitor the course of the disease and to identify novel biomarkers of drug resistance.
Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program
Breast Cancer ScreeningDigital breast tomosynthesis (DBT) creates a digital pseudo- three-dimensional image of the breast similar to mammography. This gives the screening radiologist more information about a possible abnormality. As a result, breast cancer can be found earlier, but more women might need to be recalled. In the STREAM study, the aim is to identify the impact of DBT on the screen-detected cancer and recall rates, and on interval and advanced cancer rates in 18,200 women after two rounds of screening. For comparison, a control group of about 86,400 women will be selected from the database of the national screening program. Women, screening radiographers, and screening radiologists will be asked whether they find this new screening technique acceptable. Furthermore, the optimal strategy for screening radiologists to read the DBT images will be identified and the cost-effectiveness of screening with DBT will be determined. The images and data will be stored in a database for future research. Expected outcome: As a result of this project, the researchers will have shown if breast cancer screening with DBT in the Netherlands should be implemented or not. It will also be demonstrated, were it to be introduced, how it should be implemented, having addressed all the remaining questions, and having found the optimal DBT workflow specifically for a high-volume population-based screening program.
Famitinib Plus SHR6390 and Endocrine Therapy in the Treatment of HR-positive, HER2-negative Advanced...
Metastatic Breast CancerThe main purpose of this study was to evaluate the efficacy and safety of treatment with famitinib plus SHR6390 and endocrine therapy for hormone receptor (HR)-positive, Human Epidermal Growth Factor Receptor (HER) 2 - negative advanced breast cancer.
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
Triple Negative Breast CancerThis is a Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy...
Breast CancerThe study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.
Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients
Breast CancerThis is a single center non-blinded randomized non-comparative phase II trial. The first stage of the trial consists of five arms ( with induction treatment followed by nivolumab, 1 with no induction treatment before nivolumab). For the second stage, the number of arms will be reduced based on the results obtained in the first stage.
Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer
Early-Stage Breast CarcinomaHER-2 Positive Breast CancerThe purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years. A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations.
Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer
Breast CancerNode-positive Breast Cancer3 moreSingle-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3) plans for locoregional EBRT following mastectomy with reconstruction. Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with reconstruction, cosmetic outcome.
Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast...
Advanced and Metastatic Breast CancerThis dose finding/extension study was designed originally to consist of three parts: Part A was intended to identify the MTD of the AZD2014/ palbociclib combination on a background of fulvestrant (referred to as the triplet) in postmenopausal women with locally advanced/ metastatic estrogen receptor positive (ER+) breast cancer. Part B was to further characterize safety, tolerability, PK, and preliminary efficacy in single-arm dose expansion groups. Part C was to be a Phase 2, randomized, double-blind, extension comparing the triplet and doublet combinations. Part C was deleted from the protocol and was not performed.
Shorter Course Radiation for the Treatment of Breast Cancer That Has Spread to Lymph Nodes
Breast CancerThe proposed study is being done to learn more about a particular dose of radiation treatment for breast cancer that is completed in a shorter amount of time than what has traditionally been used to treat breast cancer. Subjects are being asked to be in this research study because they have already had surgery for breast cancer and some cancer cells were found in their lymph nodes that drain the breast tissue.