Active clinical trials for "Triple Negative Breast Neoplasms"

This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free (DFS) and overall survival (OS) outcome data. This comparative data can then be used in building subsequent trials.

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC). Candidate pharmacodynamic and predictive biomarkers will also be evaluated.

This study is designed to evaluate the preliminary anti-tumor activity and tolerability of PF-03084014 when administered as a single agent in the treatment of patients with advanced triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for genomic alterations in Notch receptors (NA-)

This is a study to determine the recommended dose of birabresib (MK-8628)(formerly known as OTX015) for further studies in participants with advanced nuclear protein in testis (NUT) midline carcinoma (NMC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), or castration-resistant prostate cancer (CRPC). This is a two-part parallel study: Part A will establish the recommended dose by evaluating dose limiting toxicity (DLT), safety, discontinuation, and early efficacy and Part B will enroll participants with NMC only and will evaluate safety and efficacy in this population.

The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors

This is an open label, single arm, multi-centre phase II study to assess the anti-tumour activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in participants with previously treated, locally advanced and unresectable, or metastatic TNBC or TN-IBC. The primary objective is objective response rate.

This phase II trial studies how well Akt/ERK inhibitor ONC201 (ONC201) with a methionine-restricted (MR) diet works in treating participants with triple negative breast cancer that has spread to other places in the body or cannot be removed by surgery. ONC201 activates a process that leads to the death of a cell. ONC201 is able to target tumor cells to get rid of them, but does not affect normal cells. MR diet is a methionine-free amino acid modified medical food. The addition of an intermittent MR diet may enhance the activity of ONC201. Giving ONC201 and an MR diet may work better in treating participants with breast cancer.

This phase Ib trial studies the best dose and side effects of eribulin mesylate when given together with M7824)in treating patients with triple negative breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as M7824, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving eribulin mesylate and M7824 may work better at treating triple negative breast cancer.

TNBC, defined by the lack of immunohistochemical staining for oestrogen receptors, progesterone receptors, and lack of overexpression or amplification of HER2/neu, has an aggressive biological behaviour, marked by increased risk of recurrence and poorer survival compared with hormone receptor-positive subtypes. The key points for the rationale of the present study are: Despite different efforts for improving the outcome of TNBC patients, the median distant-disease free interval for relapsed triple-negative breast cancer is about 1-2 years, and the median survival for metastatic TNBC is approximately one year. International guidelines currently recommend polychemotherapy instead of sequential single agents as first-line treatment in this subgroup of patients, but no data is available at the moment regarding the optimal duration of chemotherapy. There is growing evidence to suggest that platinum-based therapy may have a role in both advanced and early-stage TNBC, though results are not definitive. Three randomized phase II neoadjuvant trials have been reported, two of which demonstrated an improvement in pathological complete response (pCR) rates when carboplatin is added to anthracycline and taxane-based chemotherapy, though this pCR improvement came at the cost of an increase in toxicity. Definitive results from phase III trials demonstrating improvement in long-term outcomes such as event-free and overall survival are not yet available, and it remains unclear how to optimally incorporate platinums into neoadjuvant therapy, as toxicity is enhanced when platinum is incorporated as an add-on to standard combination chemotherapy backbones. A randomized phase III trial comparing cisplatin plus gemcitabine to paclitaxel plus gemcitabine has been published recently. After a median follow-up of 16.3 months in the cisplatin plus gemcitabine group and 15.9 months in the paclitaxel plus gemcitabine group, the hazard ratio for progression-free survival was 0.692 (95% CI 0•523-0•915; pnon-inferiority<0•0001, superiority=0•009. Thus cisplatin plus gemcitabine was both non-inferior to and superior to paclitaxel plus gemcitabine. Median progression-free survival was 7.7 months (95% CI 6.2-9.3) in the cisplatin plus gemcitabine group and 6.5 months (5.8-7.2) in the paclitaxel plus gemcitabine group. In both early and advanced disease settings, response rates appear to be influenced by germ line BRCA1 and BRCA2 mutation status, and BRCA1 and BRCA2 mutation status has emerged as an important potential biomarker for platinum therapy. Outside of the BRCA mutant setting, there is certainly good reason to believe that there are patients with sporadic TNBC who stand to benefit greatly from a platinum-based approach. Tumour-based assays that detect levels of genomic scarring caused by the accumulation of DNA damage over time secondary to underlying DNA repair defects, such as the Myriad HRD assay, have potential to identify non carriers of BRCA1 or BRCA2 mutations with "BRCA-like" breast cancer, who may respond to DNA repair- targeted treatment strategies, such as platinum agents. One of the most promising way to improve clinical outcome in poor-risk patients is represented by maintenance therapy with a non-cross resistant regimen after an induction treatment, until disease progression. Nevertheless, the main limit to such a strategy is the choice of chemotherapy agents, considering that patients could be treated for a long period of time The results of the VICTOR-1 study was recently published, the aim of this study was the determination of the maximum tolerated dose of oral metronomic schedule of vinorelbine (VNR) in combination with fixed doses of capecitabine (CAPE), as well as to confirm the safety profile of the combination in a cohort of HER2-negative metastatic breast cancer patients. The results demonstrated a lower incidence of hematological grade 3-4 adverse events (1.1%), in comparison to what published in other series, using the standard schedules of the two drugs. The present study is designed to select the best arm between oral metronomic schedule of vinorelbine (VNR) and combination of oral metronomic schedule VNR with fixed doses of capecitabine (CAPE) as maintenance therapy in advanced TNBC patients responders after an induction treatment.