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Triple Negative Breast Cancer clinical trials

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NCT ID: NCT01216111 Completed - Clinical trials for Triple Negative Breast Cancer

Adjuvant Platinum and Taxane in Triple-negative Breast Cancer (PATTERN)

Start date: January 1, 2011
Phase: Phase 3
Study type: Interventional

Previous studies in Western country show that triple-negative breast cancer has aggressive clinical and pathological features compared with non-triple negative breast cancer, including onset at a young age, advanced clinical stage, high histologic and nuclear grade and more distant recurrence. According to the characteristics of triple negative breast tumor, the TNBC patients can benefit neither from hormonal therapies nor from target therapies against Her2 receptors. The only systemic therapy currently available is chemotherapy, and prognosis remains poor. It becomes more and more important to investigate the sensitive chemotherapy regimen for triple negative patients. Cisplatin-based regimen was active for the patients of lung cancer, colorectal cancer and ect. Triple negative breast cancer patients were more sensitive to platinum-based chemotherapy regimens according to the results of some retrospective studies. The investigators hypothesized that paclitaxel combined with cisplatin is more sensitive to triple negative breast cancer compared with CEF followed by docetaxel.

NCT ID: NCT01111175 Completed - Clinical trials for Metastatic Breast Cancer

Triple Negative Breast Cancer Biomarker Study

Start date: May 2010
Phase: N/A
Study type: Observational

Patients with metastatic or locally recurrent triple negative breast cancer (TNBC) who are scheduled for medically indicated surgical biopsy or resection of disease will be identified. Fresh/frozen tissue will be collected and will undergo comprehensive molecular evaluation with NextGen sequencing. TGEN's clonal genomics analyses will be applied in the analysis to identify and prioritize the mutated targets. Therapeutic options, based on the genetic profile of each patient's tumor, will be discussed and an appropriate molecularly-selected agent will be recommended by the Study Investigator(s) (SI) and treating oncologist as treatment for the patient. This is an open-label, pilot trial. Patients with metastatic or locally recurrent TNBC who are scheduled for medically indicated surgical biopsy or resection will be enrolled and therapeutic options, based on the genetic profile of each patient's tumor, will be discussed with the patient. Time-to-progression (TTP) for these patients following the selected therapy is the primary objective and will be compared to the TTP(s) for their most recent prior therapy. A 30% increase in TTP with the molecularly-targeted agent compared with the TTP on the immediate prior therapy will be considered as evidence of clinical benefit from the selected therapy. The secondary endpoints are best response to the molecularly-selected therapy, overall survival (OS) and genetic mutation evaluation in metastatic (or locally recurrent) TNBC. The study is designed to demonstrate that the collection and analysis of these tumor samples is feasible.

NCT ID: NCT01104259 Completed - Clinical trials for Stage IV Breast Cancer

Veliparib, Cisplatin, and Vinorelbine Ditartrate in Treating Patients With Recurrent and/or Metastatic Breast Cancer

Start date: July 2010
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of veliparib when given together with cisplatin and vinorelbine ditartrate in treating patients with breast cancer that has returned or spread to other parts of the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and vinorelbine ditartrate, 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. Giving veliparib together with combination chemotherapy may be a better treatment for breast cancer.

NCT ID: NCT01091454 Completed - Clinical trials for Triple-negative Breast Cancer

Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer

Start date: June 2010
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well brostallicin and cisplatin work in treating patients with breast cancer that has spread to other parts of the body (metastatic) and does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2) on its cells (triple-negative). Drugs used in chemotherapy, such as brostallicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from spreading.

NCT ID: NCT00998036 Completed - Clinical trials for Triple Negative Breast Cancer

Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors

Start date: September 2009
Phase: Phase 1
Study type: Interventional

This is a Phase I research study designed to determine the maximum tolerated dose (MTD) of cisplatin, temsirolimus, and erlotinib in combination for treatment in triple negative breast cancer (TNBC) patients.

NCT ID: NCT00986609 Completed - Breast Cancer Clinical Trials

MUC1 Vaccine for Triple-negative Breast Cancer

Start date: August 19, 2009
Phase: Early Phase 1
Study type: Interventional

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. PURPOSE: To evaluate the efficacy of poly-ICLC + MUCI peptide vaccine in boosting the immunologic response to MUCI in patients with triple-negative BC

NCT ID: NCT00951054 Completed - Clinical trials for Triple Negative Breast Cancer

A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer

Start date: February 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether NK012 is safe and effective in the treatment of advanced and metastatic triple negative breast cancer.

NCT ID: NCT00813956 Completed - Clinical trials for Triple Negative Breast Cancer

A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer

Start date: December 2008
Phase: Phase 2
Study type: Interventional

This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin, and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve a pathologic complete response prior to surgery. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

NCT ID: NCT00733408 Completed - Clinical trials for Stage IV Breast Cancer

Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer

Start date: April 23, 2008
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can prevent cancer growth by blocking the ability of cancer cells to grow and spread. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial evaluates a maintenance treatment with erlotinib and bevacizumab after Nab-paclitaxel and bevacizumab which may control cancer growth with biologic therapies.

NCT ID: NCT00707707 Completed - Breast Cancer Clinical Trials

Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer

Start date: September 15, 2008
Phase: Phase 1
Study type: Interventional

This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to be used in the randomized Phase II part. The safety and tolerability of AZD2281 in combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5 countries will be enrolled in Phase I.