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Breast Neoplasms clinical trials

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NCT ID: NCT01660776 Completed - Clinical trials for Non-small Cell Lung Cancer

BMS_PD-L1_onco : Assessment of the PD-L1 Protein as a Biomarker in Oncology and Hematology

BMS_PD-L1
Start date: June 7, 2012
Phase:
Study type: Observational

Diffuse large B-cell lymphomas (DLBCLs) represent 25 to 30% of adult non-Hodgkin lymphomas in western countries. DLBCLs are aggressive cancer but potentially curable with multi-agent chemotherapy. Whereas R-CHOP regimen has led to a marked improvement in survival, this disease remains a biologically heterogeneous entity. New therapeutic strategies are required including identification of patients' subgroups with different prognostic. This project is based on BMS_LyTrans and Goelams 075 clinical trial. A study of whole blood transcriptome in 75 DLBCL patients and in 87 controls showed that PD-L1 (CD274) gene was overexpressed in DLBCL patients. Preliminary results demonstrated that PD-L1 is detected in plasma of DLBCL patients with a significantly higher concentration than in controls. This protein was selected as a potential biomarker because of its established role in anti-tumoral immunity. Interaction between PD-L1 and its receptor PD-1 is known to inhibit activation of immune responses by inducing T-lymphocytes anergy and/or apoptosis. Moreover, a direct involvement of PD-L1 in the protection of cancer cells from lysis by activated T lymphocytes has been demonstrated. PD-L1 expression has been described in several solid tumours, including ovary cancer, breast cancer, colon cancer, renal cell carcinoma, non-small cell lung carcinoma and in hematological malignancies such as T-NHL, MM and Hodgkin's lymphoma. Furthermore the expression of PD-L1 by tumour cells is associated with poor prognosis. The blockade of PD-L1/PD-1 axis may represent a novel therapeutic approach in aggressive cancers. These first results incite to identify the cells releasing soluble PD-L1 and to investigate its role in the anti-tumoral immunity in DLBCL patients. The aim of this study is to identify cells producing soluble PD-L1 in DLBCL patients at diagnosis in comparison to others tumours known to express PD-L1 (metastatic breast cancer, Hodgkin's lymphoma, non-small cell lung cancer).

NCT ID: NCT01660542 Completed - Clinical trials for Locally Advanced Breast Cancer

An Open-label, Multi-center Phase Ⅳ Trial to Evaluate the Efficacy and Safety of Sequential Neoadjuvant Chemotherapy With Docetaxel(Monotaxel®) After Doxorubicin Plus Cyclophosphamide Combination Chemotherapy in Locally Advanced Breast Cancer

Start date: April 2011
Phase: Phase 4
Study type: Interventional

This is a multicenter, open-label, phase IV trial to assess the efficacy and safety of sequential neoadjuvant chemotherapy with 4 cycles of doxorubicin/cyclophosphamide followed by 4 cycles of docetaxel(Monotaxel®) in patients with breast cancer of ≥5cm in size or cytologically confirmed axillary lymph nodes metastasis.

NCT ID: NCT01660529 Completed - Clinical trials for Metastatic Breast Cancer

Multi-peptide Vaccine With Basilixumab for Breast Cancer

Start date: June 2012
Phase: Early Phase 1
Study type: Interventional

Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive basiliximab 20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be administered at the time of Vaccines 1,3, and 5. Patients who remain clinically stable after the fourth vaccine, may continue to receive vaccinations every 4 weeks for up to 2 years.

NCT ID: NCT01658462 Completed - Breast Cancer Clinical Trials

Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer

VAROCE-1206
Start date: May 2013
Phase: Phase 2
Study type: Interventional

National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy / Second-line chemotherapy for locally recurrent or metastatic breast cancer.

NCT ID: NCT01658358 Terminated - Clinical trials for Metastatic Breast Cancer

ErbB2 Positive Metastatic Breast Cancer

Start date: July 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Objectives: Phase I part - Primary Objective: To determine the recommended dose of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer. - Secondary Objectives:To define the safety profile; To observe the response rate and progression free survival Phase II part - Primary Objective :To determined the objective response rate of the combination of lapatinib with Lipo-Dox as first line chemotherapy in patients with ErbB2 positive metastatic breast cancer. - Secondary Objectives:To define the safety profile; To determined the progression free survival

NCT ID: NCT01658176 Withdrawn - Breast Neoplasms Clinical Trials

Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer

Start date: January 2013
Phase: Phase 2
Study type: Interventional

PF-04691502 is an inhibitor of PI3K and mTOR kinase. Exemestane is an aromatase inhibitor for the treatment of advanced breast cancer in women whose disease has progressed following tamoxifen therapy. The combination of PF-04691502 and exemestane might mitigate resistance to hormonal therapy and result in greater clinical benefit than exemestane alone in women with estrogen receptor positive advanced breast cancer.

NCT ID: NCT01658033 Completed - Clinical trials for Metastatic Breast Cancer

Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Metastatic Breast Cancer (MBC) Patients

Start date: May 2012
Phase: Phase 2
Study type: Interventional

The objective of this phase II study is to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five patients will be enrolled into this study.

NCT ID: NCT01656538 Completed - Clinical trials for Metastatic Breast Cancer

A Study of Reolysin For Patients With Advanced/Metastatic Breast Cancer

Start date: February 20, 2013
Phase: Phase 2
Study type: Interventional

Researchers doing this study want to evaluate the side effects of Reolysin when given together with paclitaxel. As these drugs have not been given together before, 6-9 patients will be treated with paclitaxel plus reolysin to ensure that side effects are tolerable.

NCT ID: NCT01655992 Terminated - Clinical trials for Metastatic Breast Cancer

A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)

Start date: January 2012
Phase: Phase 3
Study type: Interventional

Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.

NCT ID: NCT01655004 Recruiting - Breast Carcinoma Clinical Trials

Prospective Study of UDP-gluconoryltransferase 2B17 Genotype as a Predictive Marker of Exemestane PK and PD

Start date: August 2012
Phase: N/A
Study type: Interventional

Aromatase inhibitors have led to significant improvements in clinical outcomes for women with postmenopausal hormone receptor-positive advanced breast cancer. However, there is a notable absence of phase III comparisons among the three agents and therefore no clear indication of the superiority of one AI over the others. Furthermore, there remains a distinct lack of predictive biomarkers of AI efficacy and toxicity to inform clinical decisions. The metabolic pathways of exemestane have recently been delineated and UGT2B17 is the most active hepatic gluconoryltransferase responsible for the glucuronidation of the crucial active exemestane metabolite, 17-dihydroxyexemestane. The UGT2B17*2/*2 deletion genotype is associated with markedly reduced glucuronidation of 17-dihydroxyexemestane in vitro and is found more commonly in Asians than Caucasians (60-70% vs less than 10%). Our research group recently demonstrated significant reduction in glucuronidation of vorinostat, a UGT2B17 substrate, with a trend towards improved clinical benefit rate and progression-free survival in Asian breast cancer patients who were UGT2B17*2 homozygotes treated with this compound. In-vivo studies correlating UGT2B17*2 genotype with exemestane pharmacokinetics and pharmacodynamics are lacking. We hypothesize that individuals with UGT2B17*2/*2 genotype have reduced glucuronidation of 17-dihydroxyexemestane and therefore have increased exposure to the active drug, resulting in improved treatment efficacy. We propose a study of exemestane in hormone receptor positive post-menopausal advanced breast cancer patients with prospective correlation of treatment outcome by UGT2B17 genotype. The primary endpoint is the correlation of genotype (UGT2B17*2/*2 vs those with at least one wild-type variant) with clinical benefit rate, and secondary endpoints include its association with exemestane pharmacokinetics, progression-free survival, overall survival and musculoskeletal toxicities.