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Breast Cancer clinical trials

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NCT ID: NCT00711529 Completed - Breast Cancer Clinical Trials

Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes.

Start date: July 2008
Phase: Phase 3
Study type: Interventional

Premenopausal women with breast cancer who receive endocrine therapy (e.g. tamoxifen) and/or chemotherapy are at risk for experiencing premature menopause because of their treatment. The resulting symptoms, most notably hot flashes, can cause significant detriment to a patient's quality of life. Treatment for menopausal symptoms with the gold standard of hormone replacement therapy is not done routinely as it is unclear whether it can increase risk of tumor recurrence. In addition, many medical oncologists feel it is contraindicated in this population, especially among women whose breast cancers have estrogen receptors. This has lead to an increased interest in options other than estrogen replacement in the treatment of hot flashes, though most investigations of alternative medications have shown a suboptimal response. Recent studies have suggested that non-drug treatments using alternative or complementary therapies may be effective. Specifically, hypnosis has been promoted as a means to control hot flashes, though it has not been tested in a randomized fashion. In accordance with the National Cancer Institute's recent initiatives to expand the goals of clinical trials to include symptom management studies, our purpose is to evaluate the role of complementary and alternative therapies for improvement of symptoms in women with breast cancer. Specifically, we plan to evaluate the use of hypnotherapy for the treatment of therapy-induced hot flashes in breast cancer survivors. We intend to recruit 60 women into a pilot feasibility trial comparing hypnotherapy to the drug gabapentin (Neurontin®) for the treatment of therapy-induced hot flashes in eligible women who are receiving care at the Breast Health Center. We have chosen gabapentin based on recent studies showing it may be an effective non-estrogen treatment for this indication. We will identify patients who are experiencing at least one daily hot flash as a result of the treatment they received for their breast cancer for participation. When enrolled, they will be randomized into either the treatment arm, in which they will receive daily gabapentin, or the experimental arm, in which they will undergo weekly hypnotherapy. Our study hypothesis is that hypnotherapy will be more effective than gabapentin in the control of hot flashes in this population.

NCT ID: NCT00710658 Completed - Breast Cancer Clinical Trials

Internet Support for Cancer Patients

WebChoice
Start date: May 2006
Phase: N/A
Study type: Interventional

Cancer patients often experience multiple physical, functional and psychosocial symptoms, but have limited support while being at home between treatments and during rehabilitation. WebChoice is a novel Internet support system that extends traditional health services into patients' homes. The system allows patients to monitor symptoms over time, and provides access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients can ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients. This randomized clinical trial: 1. Tests the effects of WebChoice on primary outcomes of symptom distress, quality of life, depression and health service use, and secondary outcomes of self-efficacy, social support . We will also analyze: 2. Relationships between primary and secondary outcomes; 3. How patients' symptom distress varies over time; 4. Patients' preferences for participation in decision making about symptom management 5. How patients use WebChoice, such as frequency of use, duration, most used components; 6. How patients' experience WebChoice's usefulness and ease of use; 7. Patterns and content of patients' communication with the cancer nurse and other patients. 325 cancer patients (189 breast cancer and 136 prostate cancer patients) were recruited from throughout Norway through advertisements and invitation letters and the Norwegian Cancer Registry. Patients were randomly assigned to WebChoice or the control group that received usual care. Patients are being followed with 5 repeated measures over 12 months. Data are being collected through questionnaires, from system logs, and from interviews that were conducted in subset of experimental group patients. The primary hypothesis will be tested with Repeated Measures ANCOVA techniques. The other research questions will be answered using various inferential and descriptive techniques and through content analysis of messages and transcripts of patient interviews. This study can make a significant contribution to reduce unnecessary suffering and improve the quality of life for a large group of cancer patients.

NCT ID: NCT00709462 Completed - Breast Cancer Clinical Trials

A Study of CDX-1307, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX 1307-01)

Start date: March 2004
Phase: Phase 1
Study type: Interventional

This research study is for individuals who have advanced breast, colon, pancreatic, ovarian or bladder cancer. Celldex Therapeutics, Inc. is testing a form of immune therapy (vaccine) to see if it can be used to make the immune system attack the cancer. The study includes administration of additional treatments, in combination, thought to enhance the immune response effect. (CDX 1307-01)

NCT ID: NCT00709020 Completed - Breast Cancer Clinical Trials

White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Breast Cancer Survivors

Start date: June 2008
Phase: Phase 1
Study type: Interventional

RATIONALE: White button mushroom extract may stop or delay the recurrence of breast cancer in postmenopausal breast cancer survivors. PURPOSE: This phase I trial is studying the side effects and best dose of white button mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who are breast cancer survivors.

NCT ID: NCT00708903 Completed - Breast Cancer Clinical Trials

Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)

Start date: May 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).

NCT ID: NCT00707707 Completed - Breast Cancer Clinical Trials

Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer

Start date: September 15, 2008
Phase: Phase 1
Study type: Interventional

This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to be used in the randomized Phase II part. The safety and tolerability of AZD2281 in combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5 countries will be enrolled in Phase I.

NCT ID: NCT00706030 Completed - Breast Cancer Clinical Trials

Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

Start date: April 29, 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.

NCT ID: NCT00705315 Completed - Breast Cancer Clinical Trials

Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer

Start date: May 2008
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the efficacy and toxicity of docetaxel-epirubicin combination plus bevacizumab as first line treatment in patients with metastatic and HER2 negative breast cancer.

NCT ID: NCT00704158 Completed - Breast Cancer Clinical Trials

Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer

Start date: June 2008
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.

NCT ID: NCT00703638 Completed - Breast Cancer Clinical Trials

Sorafenib, Pemetrexed, and Cisplatin in Treating Patients With Advanced Solid Tumors

Start date: May 2008
Phase: Phase 1
Study type: Interventional

RATIONALE: Sorafenib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with pemetrexed and cisplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with pemetrexed and cisplatin in treating patients with advanced solid tumors.