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Triple Negative Breast Cancer clinical trials

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NCT ID: NCT03799679 Recruiting - Clinical trials for Triple Negative Breast Cancer

Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer

Start date: November 26, 2018
Phase: Phase 4
Study type: Interventional

This is an open-label, single arm, two-stage Simon Design study for women with Triple Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin. The primary objective of the trial is to evaluate of the efficacy and safety of weekly Nanoparticle Albumin-Bound Paclitaxel(Nab-P) Followed by Dose-Intensive Epirubicin in Combination with Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer. The primary endpoint of the study is to to assess Pathological complete response rate(pCR)using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).. The total number of patients to be included in this study is 60 patients. The duration of the study, from first patient visit to last patient visit will be approximately 19 months.

NCT ID: NCT03775928 Recruiting - Clinical trials for Triple-negative Breast Cancer

Compare Apatinib Plus Capecitabine Versus Capecitabine in Maintenance Therapy for Patients With Advanced Triple-negative Breast Cancer

Start date: December 18, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus capecitabine or capecitabine for maintenance therapy of patients with with advanced triple-negative breast cancer

NCT ID: NCT03671044 Recruiting - Clinical trials for Triple Negative Breast Cancer

A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients

Start date: July 10, 2018
Phase: Phase 3
Study type: Interventional

The Nanosomal Docetaxel Lipid Suspension (NDLS) consists of uniformly sized micro particles of docetaxel suspended in a lipid based formulation. The advantage of such a Lipid Based formulation of Docetaxel is an improvement of the safety profile by eliminating excipients, polysorbate 80 and ethanol which are present in conventional Docetaxel formulations (Taxotere®). This randomized, open-label study is designed to assess the efficacy and safety of Nanosomal Docetaxel Lipid Suspension at the dose of 75 mg/m2 and at the dose of 100 mg/m2 compared to Taxotere® at the dose of 100 mg/m2 in triple-negative breast cancer patients with Locally Advanced or Metastatic Breast Cancer. Patients will continue the treatment in the absence of disease progression and unacceptable toxicity. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. 657 patients (219 patients per arm) will be randomized in the study. The trial will be conducted as per the ICH GCP Guidelines E6 (R1), Schedule Y (Amended Version 2013), Declaration of Helsinki (Fortaleza, Brazil, October 2013), ICMR Guidelines for Biomedical Research on Human subjects and in accordance with other applicable guidelines.

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: 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