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Breast Neoplasms clinical trials

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NCT ID: NCT00084669 Completed - Breast Cancer Clinical Trials

Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer

Start date: May 2004
Phase: N/A
Study type: Interventional

RATIONALE: Venlafaxine may be effective in relieving hot flashes caused by hormone therapy. Giving venlafaxine with zolpidem (a sleeping pill) may improve sleep and quality of life in women who are receiving hormone therapy for treatment or prevention of breast cancer. PURPOSE: This randomized clinical trial is studying giving venlafaxine together with zolpidem to see how well it works compared to venlafaxine alone in relieving hot flashes and associated sleep disorders in women who are receiving hormone therapy to treat or prevent breast cancer.

NCT ID: NCT00084539 Completed - Breast Cancer Clinical Trials

Adjuvant Hypofractionated Intensity-Modulated Radiation Therapy With Incorporated Boost in Treating Patients With Early-Stage Breast Cancer

Start date: November 2003
Phase: Phase 2
Study type: Interventional

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells. PURPOSE: This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.

NCT ID: NCT00084396 Completed - Breast Cancer Clinical Trials

Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer

Start date: October 2003
Phase: Phase 2
Study type: Interventional

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Giving letrozole before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant letrozole works in treating postmenopausal women who are undergoing surgery for estrogen-receptor positive or progesterone-receptor positive stage II, stage IIIA, or stage IIIB breast cancer.

NCT ID: NCT00083993 Terminated - Breast Neoplasms Clinical Trials

Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

Start date: May 2004
Phase: Phase 3
Study type: Interventional

In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival. Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.

NCT ID: NCT00083733 Completed - Breast Neoplasms Clinical Trials

Genetic and Protein Profiling in Normal and Cancerous Breast Tissue

Start date: May 27, 2004
Phase: N/A
Study type: Observational

This study will collect, analyze, and compare genes and proteins in normal breast tissue with those in various tissues from women with breast cancer to look for changes that are unique to breast cancer cells. Information about these differences may lead to more effective breast cancer treatments with fewer side effects. The study has the following objectives: - To define the molecular (genetic and protein) profile of normal breast tissue from pre- and post-menopausal women of different ages and who have had varying numbers of children (or no children), and who are in different phases of the menstrual cycle - To define the molecular profile of primary breast tumors and tumors that have metastasized (spread) beyond the primary site - To characterize breast cancer stem cells and establish cell lines from the pleural fluid (fluid around the lungs) of women with metastatic breast cancer. (A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen.) The following women may be eligible for this study: - Women who are undergoing cosmetic breast surgery that requires removal of some breast tissue (e.g., breast reduction surgery) - Women 18 years of age or older who are undergoing a biopsy or other surgical procedure to sample or remove a known or suspected primary or metastatic breast tumor - Women 18 years of age or older who are undergoing pleurocentesis, a procedure to remove fluid from around the lung that is suspected or known to be caused by spread of breast cancer Participants undergo the required procedure (e.g., surgery, biopsy, or pleurocentesis) and provide information that may include the following: - Age, race/ethnicity - Age at first menstrual period (menarche) - Age at first pregnancy and age when the first child was born - Age at menopause - Information about primary breast cancer - Family history of breast cancer - Information on previous breast biopsies, if any, and hormones taken (birth control pills or hormone replacement therapy), if any - Copy of pathology report from procedure (surgery, biopsy, or pleurocentesis)

NCT ID: NCT00083304 Completed - Breast Cancer Clinical Trials

Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer

ENRICH
Start date: February 2004
Phase: Phase 3
Study type: Interventional

RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy. RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better. This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.

NCT ID: NCT00083278 Completed - Breast Cancer Clinical Trials

Study of MDX-010 in Stage IV Breast Cancer

Start date: May 2003
Phase: Phase 2
Study type: Interventional

This Phase II study is designed to treat patients who have been diagnosed with Stage IV Breast Cancer, which has progressed despite treatment with primary therapies, including hormonal therapy, chemotherapy, and antibody therapy. Thirty-three patients will be treated with the monoclonal antibody MDX-010. The initial antitumor activity profile of MDX-010 will be determined, as well as identification of the induction of any antitumor immunity following the MDX-010 treatment.

NCT ID: NCT00083174 Completed - Breast Cancer Clinical Trials

Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer

ExCel
Start date: December 3, 2004
Phase: Phase 3
Study type: Interventional

RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen. PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.

NCT ID: NCT00083148 Completed - Breast Cancer Clinical Trials

Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer

Start date: November 2002
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may help capecitabine kill more tumor cells by making tumor cells more sensitive to the drug. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan and capecitabine in treating women with advanced breast cancer.

NCT ID: NCT00083044 Withdrawn - Breast Cancer Clinical Trials

Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy

Start date: October 2003
Phase: Phase 2
Study type: Observational

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. Diagnostic procedures, such as ductal lavage, may improve the ability to assess the effectiveness of chemopreventive drugs, such as tamoxifen, on breast cells and may help doctors plan more effective treatment. PURPOSE: This phase II trial is studying how well ductal lavage works in assessing changes in breast cells in women with early breast cancer or in those at high risk of developing breast cancer who are eligible for tamoxifen therapy.