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Breast Neoplasms clinical trials

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NCT ID: NCT01795586 Completed - Breast Cancer Clinical Trials

A Phase I Dose Escalation Study of Eribulin Plus Weekly Carboplatin for Metastatic Breast Patients

Start date: February 6, 2013
Phase: Phase 1
Study type: Interventional

This study is being done to see how safe the combination of eribulin and carboplatin is and if it will work to help people with advanced breast cancer. Eribulin and carboplatin are both chemotherapy drugs. They work by killing cancer cells. A person is made up of cells which control every function in the body. Some cells stop working like they should and become cancer cells. These cancer cells grow and multiply rapidly and can cause destruction to normal body organs. Eribulin and carboplatin have both been approved by United States Food and Drug Administration (FDA) for use in the treatment of breast cancer. The combination of these two drugs and the safest dose of eribulin to use is experimental.

NCT ID: NCT01793948 Completed - Breast Cancer Clinical Trials

Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer

Start date: April 16, 2013
Phase: Early Phase 1
Study type: Interventional

This randomized clinical trial studies metformin hydrochloride in overweight or obese patients at elevated risk for breast cancer. Metformin hydrochloride may decrease the expression of early tumor makers in breast tissue of patients at increased risk for breast cancer

NCT ID: NCT01792050 Completed - Clinical trials for Metastatic Breast Cancer

Study of Chemotherapy in Combination With IDO Inhibitor in Metastatic Breast Cancer

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

The purpose of this study is to compare the effects, good and/or bad, of standard of care therapy (docetaxel or paclitaxel) with or without the addition of 1-Methyl-D-tryptophan (referred to as indoximod) an experimental drug to find out which treatment is better.

NCT ID: NCT01791985 Completed - Breast Cancer Clinical Trials

AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL)

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

This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically "blocks" proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes that help cancer cells to grow. These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug. The investigators will also test the theory that it is not necessary for high levels of FGFR1 to be present in the body to see benefit from AZD4547. (Stage 1 only)

NCT ID: NCT01790932 Completed - Breast Cancer Clinical Trials

BKM120 For Triple Negative Breast Cancer

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

Triple negative breast cancer (TNBC) has an aggressive phenotype and poor prognosis. This tumor type characterized by lack of expression of estrogen receptor (ER), progesterone receptor (PR) and no amplification of the human epidermal growth factor 2 (HER2) accounts for 15% of breast cancers. Limited treatment options exist in the clinic as hormonal therapies and HER2-trageted agents have proven ineffective. BKM120 is a drug that works by blocking a protein called phosphatidylinositol-3-kinase (PI3K) which may contribute to cancer growth. This drug has been used in experiments in the laboratory and information from these research studies suggests that BKM120 may help to prevent cancer cells from growing. In this research study, the investigators are looking to see if BKM120 works to stop breast cancer cells from growing.

NCT ID: NCT01789684 Completed - Breast Cancer Clinical Trials

Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients

SCUSF 1102
Start date: February 2014
Phase: N/A
Study type: Interventional

RATIONALE: Multi-faceted provider education and decision support intervention will increase the rate of appropriate referral of breast cancer patients at increased risk for hereditary breast and ovarian cancer (HBOC) to genetic counseling. PURPOSE: This cluster randomized controlled trial will compare active and passive interventions to increase the rate of appropriate genetic counseling referrals of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in the community oncology setting.

NCT ID: NCT01785992 Completed - Clinical trials for Metastatic Breast Cancer

A Study of the Safety and Effectiveness of Irosustat When Added to an AI in ER+ve Locally Advanced or Metastatic Breast Cancer.

IRIS
Start date: October 2012
Phase: Phase 2
Study type: Interventional

70% of breast cancers that occur in postmenopausal women rely on the hormone oestrogen to grow and are likely to respond to hormone treatment. This type of treatment reduces the amount of oestrogen in the body, slowing the growth of cancer or stopping it altogether. One type of hormone treatment, aromatase inhibitors (AIs), works by stopping the body from making oestrogen. Currently, women with locally advanced or metastatic breast cancer that is not being controlled by one class of AI are switched to the other class of AI. The reason for this is that some cancer cells can become resistant to one class but are still sensitive to the other class. However, oestrogen can be made in the body by two pathways and AIs block only one of these pathways. A new drug called Irosustat can reduce the production of oestrogen in the body by blocking the second pathway. This study is investigating whether adding Irosustat to AI treatment i.e. blocking both pathways at the same time, can further reduce the amount of oestrogen in the body and therefore control the breast cancer better. 27 postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer that is not being controlled by their current AI treatment will be recruited in this study from 9 United Kingdom (UK) hospitals. Eligible patients will receive 40mg of Irosustat once daily in addition to the AI on which they progressed. Patients will receive Irosustat for as long as it controls their cancer or until they have side effects that stop them from taking treatment. Patients will be seen monthly for the first 6 months and every 3 months thereafter. Participating patients will also be given the option to take part in the exploratory part of this study by donating tissue and blood samples.

NCT ID: NCT01783756 Completed - Clinical trials for HER2-positive Breast Cancer

Phase 1b/2 Trial Using Lapatinib, Everolimus and Capecitabine for Treatment of HER-2 Positive Breast Cancer With CNS Metastasis

Start date: June 26, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1b/2 study to evaluate the safety and clinical activity of the combination of lapatinib, everolimus and capecitabine for the treatment of participants with HER2+ breast cancer with metastases in the brain who have progressed on trastuzumab. The combination of 2 drugs able to reach the brain (lapatinib and everolimus) that target different parts of the HER2 signaling pathway plus chemotherapy (capecitabine) that has proven benefits in metastatic breast cancer may lead to improved clinical outcomes for participants with CNS metastasis. Participants will undergo brain MRIs and CT scans of the chest and abdomen to evaluate response to the treatment, regular laboratory tests and echocardiogram or Multi Gated Acquisition Scan (MUGA) to assess cardiac activity

NCT ID: NCT01783444 Completed - Breast Cancer Clinical Trials

A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.

BOLERO-6
Start date: February 26, 2013
Phase: Phase 2
Study type: Interventional

This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.

NCT ID: NCT01782651 Completed - Neoplasms, Breast Clinical Trials

Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients

Start date: August 2014
Phase: N/A
Study type: Observational

This study will describe the treatment paradigm used over recent years in the clinical management of Human Epidermal Growth Factor Receptor 2 (HER2)+ metastatic breast cancer in Hungary. This information will provide insight into real-world exposure and adherence to anti-HER2 therapy containing regimens, and improve understanding of the reasons for discontinuation of this therapy. This is a retrospective, descriptive, cohort study of approximately 180 female patients diagnosed with HER2-positive metastatic breast cancer in Hungary. Patients diagnosed with, or who progressed to, metastatic disease between 01 September 2009 and 01 September 2010 will be included. All patients will be followed until death, loss to follow-up or the end of the study period (30 September 2012). All data will be collected retrospectively from patient medical records. Descriptive statistics of the demographic and clinical characteristics of HER2+ metastatic breast cancer patients, including sites of metastases, the time from initial breast cancer diagnosis until diagnosis of metastatic disease, and HER2 testing methodology and status of HER2 will be described. Further, descriptive statistics of the proportion of HER2+ metastatic breast cancer patients who received anti-HER2 therapy, the sequencing of different therapies, and the duration of therapies in the metastatic setting will be analysed. Among the subset of women who receive lapatinib plus capecitabine, descriptive statistics of the timing of initiation of lapatinib plus capecitabine in the metastatic treatment pathway, time to treatment discontinuation and time to progression (TTP) on lapatinib plus capecitabine will be calculated. Further, descriptive statistics of the type and duration anti-HER2 therapies used prior to initiation of lapatinib plus capecitabine and, where relevant, after lapatinib+capecitabine will be performed.