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Breast Cancer clinical trials

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NCT ID: NCT00938652 Completed - Breast Cancer Clinical Trials

A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer

Start date: July 2009
Phase: Phase 3
Study type: Interventional

The goal of this study was to determine the effect on overall survival and progression free survival by adding iniparib (BSI-201/SAR240550) to the combination of gemcitabine/carboplatin in adult patients with triple negative breast cancer (estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative). Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the poly (ADP-ribose) polymerase (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: NCT00937989 Completed - Breast Cancer Clinical Trials

Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer

Start date: November 2008
Phase: N/A
Study type: Interventional

RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life. PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.

NCT ID: NCT00936442 Completed - Breast Cancer Clinical Trials

Arimidex Therapy Compliance Electronic Monitoring System

ARTEMIS
Start date: June 2009
Phase: N/A
Study type: Observational

ARTEMIS is a study to assess how educational material affects overall adherence to anastrozole by evaluation of patients' electronically compiled dosing histories. Patients' dosing times are compiled electronically using Medication Event Monitoring System" (MEMS®) in order to be able to gather accurate, objective and up-to-date patients' dosing histories. For subjects in Group A, the control group, the adherence to anastrozole in the standard clinical practice will be evaluated. For subjects in Group B, on top of the standard clinical practice, they will also receive educational material by mail at week 0 (study registration), week 2, week 4, week 6, week 8, week 12, month 5, month 7, and at month 10. This procedure is the same as in the ongoing CARIATIDE study. One of the reasons of poor adherence (either early discontinuation of the treatment or missing doses while still engaged to the therapy) can be some side effects experienced by the patients during the anastrozole treatment. Recording the reasons at discontinuation allows us to identify reasons for treatment discontinuation. Recording reasons of anastrozole interruptions during the study period allows us to relate these events to patients' adherence to anastrozole. During the study, no pro-active safety data collection will take place. Spontaneous reported adverse drug reactions (ADRs) will be reported according to local post-marketing pharmacovigilance regulations.

NCT ID: NCT00934856 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Patients With Advanced Breast Cancer

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

This open-label, multi-center study will assess the safety and tolerability of adding trastuzumab emtansine (T-DM1) to docetaxel in patients with locally advanced or metastatic HER2-positive breast cancer. Patients will receive T-DM1 and docetaxel on Day 1 of each 3-week cycle. For patients with locally advanced breast cancer, pertuzumab may be added to trastuzumab emtansine and docetaxel. Anticipated time on study treatment is up to 6 cycles for patients with locally advanced breast cancer, until disease progression or unacceptable toxicity occurs for patients with metastatic breast cancer.

NCT ID: NCT00933309 Completed - Breast Cancer Clinical Trials

The Impact of Obesity and Obesity Treatments on Breast Cancer

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

The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body.

NCT ID: NCT00932997 Completed - Breast Cancer Clinical Trials

Survivorship Booklets With or Without Individual Telephone Sessions in Increasing Knowledge About the Impact of Breast Cancer in African American and Latina Breast Cancer Survivors

Start date: October 2006
Phase: N/A
Study type: Interventional

RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors. PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.

NCT ID: NCT00932035 Completed - Breast Cancer Clinical Trials

Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer

Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.

NCT ID: NCT00930930 Completed - Breast Cancer Clinical Trials

Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer

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

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving chemotherapy together with everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether cisplatin and paclitaxel are more effective when given together with or without everolimus in treating patients with breast cancer. PURPOSE: This randomized phase II trial is studying how well cisplatin and paclitaxel work when given together with or without everolimus in treating patients with stage II or stage III breast cancer.

NCT ID: NCT00930579 Completed - Breast Cancer Clinical Trials

Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation

Start date: October 16, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.

NCT ID: NCT00929617 Completed - Breast Cancer Clinical Trials

Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II)

BEAT
Start date: June 2009
Phase: N/A
Study type: Interventional

The purpose of the study is to compare the effects of one exercise/counseling protocol with usual care on long term exercise adherence and on changes in health related outcomes after breast cancer diagnosis.