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Triple Negative Breast Neoplasms clinical trials

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NCT ID: NCT03617341 Recruiting - Clinical trials for Triple Negative Breast Cancer

Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer

Start date: October 2, 2018
Phase:
Study type: Observational

In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.

NCT ID: NCT03606967 Recruiting - Clinical trials for Anatomic Stage IV Breast Cancer AJCC v8

Testing the Addition of an Individualized Vaccine to Nab-Paclitaxel, Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

Start date: April 13, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, 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 durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.

NCT ID: NCT03586297 Recruiting - Clinical trials for Triple Negative Breast Cancer

Gut and Intratumoral Microbiome Effect on the Neoadjuvant Chemotherapy-induced Immunosurveillance in Triple Negative Breast Cancer

Start date: August 27, 2017
Phase:
Study type: Observational

The probability of pCR in TNBC patients receiving standard of care neoadjuvant chemotherapy treatment is associated with the dominance of specific intestinal and intratumoral microbiota that promote anti-tumor immunosurveillance.

NCT ID: NCT03562637 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Globo H Positive TNBC

Start date: December 5, 2018
Phase: Phase 3
Study type: Interventional

The GLORIA study is a Phase III, randomized, open-label study to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI 822)/OBI-821 in the adjuvant treatment of patients with high risk, early stage Globo-H Positive TNBC.

NCT ID: NCT03504488 Recruiting - Clinical trials for Head and Neck Cancer

CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

Start date: June 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

NCT ID: NCT03475953 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

REGOMUNE
Start date: May 4, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Assessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial). Assessement of the efficacy and safety of a low-dose of regorafenib (80mg/day) with avelumab in patients with advanced or metastatic colorectal tumors.

NCT ID: NCT03401385 Recruiting - Clinical trials for Non-small Cell Lung Cancer

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

Start date: January 31, 2018
Phase: Phase 1
Study type: Interventional

This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study. The primary purpose of the parts are: - Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a - Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors This study is expected to last approximately 6 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: - they withdraw - their disease gets worse - they experience unacceptable side effects. The primary purpose of the sub-study is to compare the effectiveness of steroid versus non-steroid mouthwash as prophylaxis against oral mucositis/stomatitis in participants receiving DS-1062a. The sub-study is a randomized study that will include approximately 76 participants enrolling into the Dose Expansion part.

NCT ID: NCT03348098 Recruiting - Clinical trials for Triple Negative Breast Cancer

Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer

Start date: September 6, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of apatinib in patient with TNBC

NCT ID: NCT03332368 Recruiting - Recurrence Clinical Trials

Clinical Study on Triple Negative Breast Cancer With Chinese Medicine

Start date: January 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Breast cancer is one of the most serious threat to women's health of malignant tumors, also the most common causes of cancer death in women.Triple-negative breast cancer (TNBC) refers to the immunohistochemical detection of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor-2 (Her-2) are negative.Compared with other types of breast cancer, TNBC has a high degree of invasion,local recurrence and metastasis. Also,TNBC can not use endocrine therapy and lack of molecular targeting for Her-2 target therapy.Meanwhile other biological agents are too expensive,so the current clinical therapy only can use in China is chemotherapy,the average survival time is about 2 years. Fortunately,due to the impact of traditional Chinese medicine(TCM) in China, the majority of breast cancer patients have received varying degrees of TCM treatment, and because of TNBC patients can not be more mature endocrine therapy and anti-molecular targeted therapy Benefits, Chinese medicine play an important role in TNBC patients.TCM regulate immune function, inhibit tumor growth, Anti-recurrence and metastasis, to extend the survival of patients with tumor, and relative to chemotherapy drugs and molecular targeted drugs,improve the quality of life.In addition ,comparing with the biological agents,Chinese medicine prices are relatively low,and can be worth using widely. With the development of evidence-based medicine, and gradually recognize the importance of comprehensive treatment of breast cancer, Cancer Treatment Model has been proposed,.That is, to take Chinese medicine, surgery, radiotherapy and chemotherapy, endocrine therapy and biological immunization and other standardized, individualized comprehensive treatment. The introduction of evidence-based medicine into the field of research, will be beneficial to the objective evaluation of TCM syndrome differentiation in the treatment of refractory breast cancer in the characteristics and advantages in order to promote the use of. This study based on TCM syndrome differentiation and treatment, and adopts multi-center, randomized, double-blind and controlled research methods to evaluate whether the intervention of traditional Chinese medicine can improve the TNBC patients with disease-free survival (DFS), overall survival(OS),and the best time to intervene in traditional Chinese medicine; also the establishment of the exact effect, obvious advantages and evidence, can be promoted in line with clinical practice of the program, the formation of refractory breast Cancer and Western medicine combined with clinical path, and relying on the national clinical research base of Chinese medicine information platform, the construction of clinical information management cloud platform, the formation of active medical service process, the establishment of refractory breast cancer combined with clinical prevention and treatment center, improve the life quality level of TNBC patients. The study contains 5 locations,including Longhua Hospital, Shuguang Hospital,Yueyang Hospital,Zhejiang Traditional Chinese Medicine Hospital and Fudan University Cancer Hospital.Considering of the results of the study at MD Anderson Cancer Center in foreign countries showed that the 3-year survival rate of TNBC patients was significantly shorter than that of non-TNBC patients (74% vs.89%, P <0.01) To be at least 10% survival rate.At the same time, considering the case lost rate of 20%, calculated by PASS software, the number of samples for each group of 310 cases, a total of 620 cases of cohort study. According to whether to take traditional Chinese medicine,all the participants are divided into exposure group and non-exposure group, the number of observations per group is 310. Before the research, all participants needs to fill in the informed consent form, investigators introduce the clinical research related matters to them and record the basic situation. The Chinese medicine exposure group take Chinese medicine(San Yin Decoction ) besides of original Western medicine , non-exposed group only received Western medicine treatment, a total of two years.All results are recorded in the CRF table,and use SPSS18.0, Stata10.0 and other statistical software for data to analysis.

NCT ID: NCT03165487 Recruiting - Clinical trials for Triple Negative Breast Cancer

Comparison of the Breast Tumor Microenvironment

Start date: September 28, 2017
Phase:
Study type: Observational

The goal of the project is to identify a molecular signature of tumor stroma from "normal" adjacent breast tissue obtained prospectively at the time of breast conserving surgery before and after receiving intraoperative radiation therapy (IORT) in subjects that have luminal A and triple negative breast cancer. IORT is considered as being standard of care.