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Breast Neoplasms clinical trials

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NCT ID: NCT01204242 Completed - Breast Cancer Clinical Trials

IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery:

Start date: August 1, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given during anesthesia intravenously (IV) through a needle in your vein,), can: 1. Help decrease pain after surgery. 2. Have you need less pain medication. 3. Have less side effects like nausea and vomiting following your surgery. 4. Help to prevent chronic pain. 5. Affect recurrence of cancer after surgery.

NCT ID: NCT01204125 Completed - Clinical trials for Breast Cancer Female

Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients

SOLTI NEOPARP
Start date: September 2010
Phase: Phase 2
Study type: Interventional

Primary Objective: - to assess the pathological Complete Response (pCR) rate in the breast of patients treated in following combinations: SAR240550 twice-weekly + weekly paclitaxel, SAR240550 weekly+ weekly paclitaxel, and weekly paclitaxel single agent as calibrator. Secondary objectives are: - pCR rate in the breast and axilla, - Radiological/clinical objective response rate (ORR), breast conservation rate, disease free survival (DFS), and overall survival (OS), in each treatment arm, - Safety profiles of study combinations and of the single agent reference treatment, - Molecular characteristics of the tumor tissue and peripheral blood mononuclear cells (PBMC) and any correlation between the biological activity of the study treatment and the disease outcome. 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: NCT01203267 Completed - Breast Cancer Clinical Trials

Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer

Start date: December 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.

NCT ID: NCT01202591 Completed - ER+ Breast Cancer Clinical Trials

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

GLOW
Start date: December 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)

NCT ID: NCT01201265 Completed - Breast Cancer Clinical Trials

A Study of Avastin (Bevacizumab) in Combination With Gemcitabine and Carboplatin as First Line Treatment in Patients With Triple Negative Metastatic Breast Cancer

Start date: February 2011
Phase: Phase 2
Study type: Interventional

This multicenter study will assess the efficacy and safety of Avastin (bevacizumab) in combination with gemcitabine and cisplatin as first line treatment in patients with triple negative metastatic breast cancer. Patients will receive Avastin at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an AUC=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.

NCT ID: NCT01199432 Completed - Breast Cancer Clinical Trials

Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer

Start date: October 2010
Phase: Phase 4
Study type: Interventional

This is a phase IV, prospective, single-center, open-label, randomized, controlled study. Eligible patients are randomly assigned into three groups. The investigators propose to evaluate and compare the efficacy and safety of different neoadjuvant chemotherapies in women with primary breast cancer.

NCT ID: NCT01199393 Completed - Breast Neoplasm Clinical Trials

Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

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

The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.

NCT ID: NCT01198457 Completed - Multiple Myeloma Clinical Trials

Study to Investigate Adherence of Patients to Clodronate (Bonefos) Treatment

BONA
Start date: January 2009
Phase: N/A
Study type: Observational

Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).

NCT ID: NCT01198301 Completed - Breast Neoplasms Clinical Trials

Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy

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

The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer.

NCT ID: NCT01197456 Completed - Breast Cancer Clinical Trials

Predictors of Ovarian Insufficiency in Young Breast Cancer Patients

POISE
Start date: September 24, 2008
Phase:
Study type: Observational

More than two million American women are breast cancer survivors. Approximately one-third of these women are premenopausal at diagnosis and face issues related to reproduction as they undergo cancer treatment. Ovarian function after breast cancer diagnosis has implications on breast cancer prognosis, choice of adjuvant therapy and reproductive issues such as desire for fertility or concerns about menopause. Therefore, tools to accurately predict ovarian function in breast cancer survivors could significantly impact physicians and patients in counseling, medical and surgical treatment choices, and consideration of fertility preservation options. The goal of this proposal is to identify pre-chemotherapy hormonal, genetic and ovarian imaging markers that can predict ovarian failure and characterize the course of ovarian function after chemotherapy. The investigators plan to follow a group of young women from breast cancer diagnosis to five years after chemotherapy. The investigators will study the following risk factors: blood hormone levels that reflect ovarian function, genetic mutations that affect how individuals metabolize chemotherapy, and ovarian size and egg count by MRI and ultrasound. The investigators hypothesize that these biomarkers are related to risk of ovarian insufficiency singly. After examining these individual risk factors for ovarian failure, the investigators will put them together into an Ovarian Failure Clinical Predictive Index. This index will be a tool similar to the Gail Model that can be used to determine individual risk for ovarian failure. This tool would assist young breast cancer patients and their physicians in making treatment decisions that would impact cancer survival and reproduction.