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Breast Neoplasms clinical trials

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NCT ID: NCT01240928 Withdrawn - Clinical trials for Metastatic Breast Cancer

MK-2206+Endocrine Therapy in Patients With Hormone Receptor-Positive Breast Cancer

Start date: n/a
Phase: Phase 1
Study type: Interventional

This is a phase Ib trial that evaluates the safety and tolerability of MK-2206 given in combination with exemestane +/- goserelin in pre- and post-menopausal patients with hormone receptor-positive metastatic breast cancer.

NCT ID: NCT01229605 Withdrawn - Breast Cancer Clinical Trials

Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer

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

The standard therapy for patients who have locally advanced breast cancer is to receive chemotherapy before surgical removal of tumor. This is called neoadjuvant chemotherapy (NAC). Chemotherapy is used to shrink the tumor before surgery, which sometimes may allow for a smaller portion of the breast to be removed. Receiving chemotherapy before surgery may sometimes also allow for smaller portions of the breast to be removed. Getting chemotherapy prior to surgery may also control any hidden metastatic disease and thereby decrease the risk of cancer relapse. Pre-surgery chemotherapy is a standard management approach for locally advanced breast cancer. Different combinations of drugs can be used as part of the pre-surgery chemotherapy. The purpose of this study is to determine if using a chemotherapy regimen of TC is effective way to manage locally advanced breast cancer (Stage IIA- IIIB) when the TC is given before surgery. The investigators also hope this study will help us to better understand how the tumor tissue is affected by this combination of chemotherapy drugs. The TC drug combination is FDA approved for use in treating breast cancer, and it has been shown to be equally effective as other commonly used chemotherapy regimens when used after surgery; but, the TC drug combination has not yet been studied in conjunction with NAC for use before surgery. The investigators will be studying the combination of TC used before surgery as a means of possibly shrinking the tumor.

NCT ID: NCT01227408 Withdrawn - Breast Cancer Clinical Trials

Neoadjuvant Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer

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

The investigators propose to conduct a clinical trial of neoadjuvant treatment utilizing chemotherapy formulations with favorable toxicity profiles: weekly doxorubicin, PPX and capecitabine. It is expected this combination will at least maintain the efficacy of a traditional chemotherapy regimen but will be associated with less toxicity, particularly nausea, vomiting and alopecia. In order to accomplish this the investigators have designed a chemotherapy regimen whose components (or administration schedule) are associated with minimal or no alopecia and are also considered to have low emetogenic potential. In an attempt to improve the efficacy of the regimen the investigators plan to study an alternate schedule of cyclophosphamide and methotrexate administration (metronomic chemotherapy) which appears to inhibit angiogenesis and therefore enhance the activity of conventional cytotoxic chemotherapy administered concurrently. In this trial the investigators aim to determine the clinical and pathologic response rate of 12 weeks of doxorubicin followed by 4 cycles of PPX and capecitabine. Metronomic chemotherapy with cyclophosphamide and methotrexate will be administered during the 24 weeks of chemotherapy.

NCT ID: NCT01219907 Withdrawn - Clinical trials for HER2-positive Breast Cancer

Ex Vivo-Expanded HER2-Specific T Cells and Cyclophosphamide After Vaccine Therapy in Treating Patients With HER2-Positive Stage IV Breast Cancer

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

RATIONALE : Laboratory-treated T cells may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from HER2 peptides may help the body build an effective immune response to kill tumor cells that express HER2. Giving laboratory-treated T cells and cyclophosphamide after vaccine therapy may be an effective treatment for breast cancer. PURPOSE: This phase I trial is studying the side effects and best dose of ex vivo-expanded HER2-specific T cells when given together with cyclophosphamide after vaccine therapy in treating patients with HER2-positive stage IV breast cancer.

NCT ID: NCT01205217 Withdrawn - Neoplasms, Breast Clinical Trials

Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer

ELATE
Start date: December 2010
Phase: Phase 2
Study type: Interventional

This study will test the safety of a drug called lapatinib and how well it works. Lapatinib (also called Tyverb or Tykerb) will be compared with another drug trastuzumab (also called Herceptin). Trastuzumab is an antibody against the HER2 protein. It binds to part of the HER2 protein to stop it working. Clinical trials have found that adding trastuzumab to chemotherapy lowers the rate of cancer recurrence and improves survival in women with HER2 positive breast cancer. Lapatinib also stops the HER2 protein working and may slow or stop cancer cells from growing and may prevent cancer from returning. Lapatinib has been approved in some countries to treat patients with certain types of breast cancer. However lapatinib has not been approved to treat early breast cancer. This study is one of many being carried out involving lapatinib in early breast cancer and these studies are showing that it is a promising treatment. This study will compare lapatinib and trastuzumab. One group of people will take lapatinib and another group will take trastuzumab. The effects of the drugs, both good and bad, will be compared. This study will compare two different durations of HER2 treatment to see if earlier introduction of HER2 treatment is beneficial. The lapatinib group will receive HER2 treatment from the very beginning for 24 weeks prior to surgery and the trastuzumab group will only receive HER2 therapy for 12 weeks prior to surgery.

NCT ID: NCT01169870 Withdrawn - Breast Cancer Clinical Trials

Genexol-PM Versus Paclitaxel in Anthracycline-pretreated Metastatic Breast Cancer Patients

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

The purpose of this study is to evaluate the overall response rate of Genexol-PM compared with paclitaxel (cremophor-based paclitaxel) as palliative chemotherapy in anthracycline-pretreated patients with metastatic breast cancer.

NCT ID: NCT01163929 Withdrawn - Breast Cancer Clinical Trials

A Study to Look at the Combination of Chemotherapy, Trastuzumab and RAD001 in HER2 Positive Breast Cancer

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

The primary objective of this study is to assess whether a combination of chemotherapy, Trastuzumab and RAD001 will result in no evidence of microscopic disease at the time of surgery in 50% of enrolled patients.

NCT ID: NCT01159236 Withdrawn - Breast Cancer Clinical Trials

Molecular Triaging of Newly Diagnosed Breast Cancer

Start date: September 2010
Phase: N/A
Study type: Interventional

The goal of this clinical research study is to learn if using "gene signatures" can be an effective way to decide the best treatment for breast cancer patients. Gene signatures may be able to help researchers predict who will respond to chemotherapy given before surgery.

NCT ID: NCT01156961 Withdrawn - Breast Cancer Clinical Trials

A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)

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

This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01141868 Withdrawn - Breast Cancer Clinical Trials

Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors

Start date: July 2010
Phase: N/A
Study type: Interventional

This study examines the efficacy of an Internet-delivered intervention to reduce symptoms of insomnia in breast cancer survivors. Breast cancer patients with insomnia (N=30) will be assigned to either gain access to the 6-week treatment program immediately (experimental group) or following study participation (control group).