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Breast Neoplasms clinical trials

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NCT ID: NCT00027807 Completed - Breast Cancer Clinical Trials

Biological Therapy in Treating Women With Stage IV Breast Cancer

Start date: October 2001
Phase: Phase 1
Study type: Interventional

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining different biological therapies in treating women who have stage IV breast cancer.

NCT ID: NCT00027118 Completed - Breast Cancer Clinical Trials

Morbidity After Diagnosis and Treatment of Breast Cancer Patients

Start date: November 16, 2001
Phase:
Study type: Observational

This study will examine the frequency and severity of problems in women with breast cancer for 2 years following initial medical treatment, including: - Physical impairments, such as loss of strength or flexibility, increased weight and swelling. - Symptom distress, such as pain, fatigue and weakness. - Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities. It will identify factors associated with these problems and try to determine their relationship to them. Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible for this study. Women who have a breast biopsy negative for cancer will also be enrolled as control subjects. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2001-2003. Participants will be evaluated over a 2-year period during an initial baseline visit (before medical treatment or biopsy) and follow-up visits at 1, 3, 6, 12, 18 and 24 months following procedures: - Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living. - Completion of questionnaires including health survey, upper limb disability questionnaire, and physical activity questionnaire. (Questionnaires are completed only at baseline and 12 and 24 months after medical treatment begins.) The questionnaires take about 30 to 40 minutes to complete. - Upper body examination, including pain measurement using a 10-point scale, active and passive range of motion measures, manual muscle testing measures using a 10-point scale, timed upper limb lift test, and measures of upper limb volume and girth.

NCT ID: NCT00027105 Completed - Breast Cancer Clinical Trials

Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer

Start date: November 16, 2001
Phase:
Study type: Observational

This study will examine the frequency and severity of problems in women with breast cancer during the first year after initial medical treatment, including: - Physical impairments, such as loss of strength or flexibility, increased weight and swelling - Symptom distress, such as pain, fatigue and weakness. - Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities. It will identify factors associated with these problems and try to determine their relationship to them. Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible for this study. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2000-20001. Participants will be interviewed and their medical records reviewed for past medical history, history of the present illness and social and recreational history. They will be seen five times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute visits, which will include the following: - Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living. - Complete health survey and upper limb disability questionnaire; physical activity questionnaire to be completed at 6 and 12 months after medical treatment begins. The questionnaires take about 30 to 40 minutes to complete. - Upper body examination, including pain measurement using a 10-point scale, an upper limb lift test, and measures of upper limb volume and girth.

NCT ID: NCT00026949 Completed - Breast Cancer Clinical Trials

Study of Etoposide in Breast Cancer Patients

Start date: August 1999
Phase: N/A
Study type: Observational

This study will examine how the body handles etoposide, a drug used to treat breast cancer. The knowledge gained may lead to more effective use of the drug with fewer side effects in the future. Breast cancer patients who are receiving etoposide as part of their treatment may participate in this study. Patients will have 18 blood samples (about a teaspoon or less each) drawn over a 72-hour period during and after their infusion of etoposide. The initial blood samples cannot be taken from the same intravenous line (small tube placed in a vein) used to deliver the etoposide, so a second line may have to be placed temporarily to obtain these samples.

NCT ID: NCT00026286 Completed - Breast Cancer Clinical Trials

Hormone Replacement Therapy for Hot Flashes and/or Vaginal Symptoms in Postmenopausal Women Receiving Tamoxifen for Breast Cancer

Start date: November 28, 2000
Phase: Phase 3
Study type: Interventional

RATIONALE: Hormone replacement therapy may be effective in managing the hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone replacement therapy in managing hot flashes and/or vaginal symptoms in postmenopausal women who are receiving tamoxifen for breast cancer.

NCT ID: NCT00026117 Completed - Breast Cancer Clinical Trials

Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

Start date: August 2001
Phase: Phase 3
Study type: Interventional

RATIONALE: Shark cartilage extract may help shrink or slow the growth of colorectal cancer or breast cancer cells. PURPOSE: Randomized phase III trial to determine the effectiveness of shark cartilage in treating patients who have advanced colorectal cancer or advanced breast cancer.

NCT ID: NCT00025584 Completed - Clinical trials for Stage IV Breast Cancer

PS-341 in Treating Women With Metastatic Breast Cancer

Start date: August 2001
Phase: Phase 2
Study type: Interventional

PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer

NCT ID: NCT00024154 Completed - Clinical trials for Stage IV Breast Cancer

Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer

Start date: February 2002
Phase: Phase 2
Study type: Interventional

This phase II trial is studying how well giving trastuzumab together with gefitinib works in treating patients with HER2-positive breast cancer. The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as gefitinib may also interfere with the growth of tumor cells and may enhance the effects of trastuzumab. Combining trastuzumab with gefitinib may be an effective treatment for metastatic breast cancers with high amounts of HER2

NCT ID: NCT00024102 Completed - Breast Cancer Clinical Trials

Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer

Start date: September 2001
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.

NCT ID: NCT00022672 Completed - Breast Cancer Clinical Trials

A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

Start date: January 2001
Phase: Phase 3
Study type: Interventional

This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.