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Breast Neoplasms clinical trials

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NCT ID: NCT00567190 Completed - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

CLEOPATRA
Start date: February 12, 2008
Phase: Phase 3
Study type: Interventional

This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.

NCT ID: NCT00566618 Completed - Breast Cancer Clinical Trials

Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis

Start date: November 1, 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical research study is to find the highest tolerable dose of dasatinib and Zometa (zoledronic acid) that can be given in combination for the treatment of breast cancer that has spread to the bone. The safety and effectiveness of this combination will also be studied.

NCT ID: NCT00566085 Completed - Breast Cancer Clinical Trials

New Technique as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer

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

Molecular Breast Imaging is a highly promising novel methodology for breast cancer detection. Preliminary patient studies with our dual-detector system indicate that this system is capable of reliably detecting very small (5-10 mm) malignant lesions in the breast. Besides the usefulness of Molecular Breast Imaging for tumor detection, we speculate that tumor uptake and washout may be predictors to response to neoadjuvant therapy for patients with the diagnosis of breast cancer. We propose that in patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy that molecular breast imaging is an accurate test for assessing response rate to neoadjuvant therapy.

NCT ID: NCT00565305 Completed - Breast Cancer Clinical Trials

Healing Touch, Quality of Life, and Immunity During Breast Cancer Treatment

Start date: July 2003
Phase: N/A
Study type: Interventional

The purpose of this research study is to understand effects of a complementary medicine therapy, Healing Touch on quality of life and immunity of patients who are receiving treatment for breast cancer. Healing Touch is a Holistic Therapy used as an adjunct to medical treatment. The goal of Healing Touch is to restore energy and vitality to the body as a patient is receiving treatment for cancer. Treatments include light touch on specific points on the body as well as around the body, to increase well-being and support the body's ability to heal. Healing Touch has been shown to increase relaxation and well-being and to decrease anxiety, pain, and treatment side effects in a variety of illnesses including cancer. Although Healing Touch is frequently used by cancer patients along with their medical treatments, very little is understood about the effects of this treatment on the immune system. The immune system is known to be important in the body's response to fighting cancer. We are studying Healing Touch to help us understand whether or not these treatments are effective in supporting the immune system during breast cancer treatment Aim 1. To evaluate effects of a healing touch (HT) intervention on cellular immunity among early stage breast cancer patients during radiotherapy. Aim 2. To evaluate effects of a Healing Touch (HT) intervention on cytokines associated with radiation damage and acute skin reactions in early stage breast cancer patients during radiotherapy. Aim 3. To evaluate the effects of a Healing Touch intervention on fatigue and mood in early stage breast cancer patients during radiation treatment.

NCT ID: NCT00563953 Completed - Breast Cancer Clinical Trials

Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years

CAPRICE
Start date: September 2007
Phase: Phase 2
Study type: Interventional

This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at surgery.

NCT ID: NCT00562718 Completed - Breast Cancer Clinical Trials

Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery

Start date: September 2004
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving capecitabine together with radiation therapy works in treating patients with nonmetastatic breast cancer.

NCT ID: NCT00562458 Completed - Clinical trials for Advanced Breast Cancer

Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer

Start date: December 2006
Phase: N/A
Study type: Observational

To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.

NCT ID: NCT00561119 Completed - Clinical trials for Advanced Breast Cancer

Maintenance Versus Observation After 6 Cycles of Gemcitabine Plus Paclitaxel in Pts With Advanced Breast Cancer

Start date: May 2007
Phase: Phase 3
Study type: Interventional

The primary goal of therapy in patients with metastatic breast cancer is palliation and prolongation of life with quality. Although there are no randomized trials comparing chemotherapy with supportive care in women with metastatic breast cancer, chemotherapy clearly provides a survival benefit in metastatic breast cancer. Due to diagnosis at earlier phases of metastatic disease and more effective therapies, the median survival of patients treated with modern taxane-based chemotherapy is now reaching approximately 2 years. The duration of chemotherapy in patients responding or stable disease remains controversial, since quality of life is not usually adversely affected and may even be improved in many patients receiving cytotoxic chemotherapy. In addition, many commonly used chemotherapeutic agents are not limited by cumulative toxicity in metastatic breast cancer patients. Several studies investigated the role of maintenance chemotherapy suggest that maintenance chemotherapy is associated with superior time to progression but no survival gain. However, these randomized trials did not incorporate taxane-based chemotherapeutic regimens, the new standard of care in metastatic breast cancer patients these days. A 1998 metaanalysis of 1,986 patients randomly assigned between combination chemotherapy and single-agent therapy in metastatic breast cancer patients demonstrated a survival advantage to combination chemotherapy, with a hazard ratio of 0.82 (range, 0.75 to 0.90). Although there are several randomized trials showing negative results for survival gain in patients who received maintenance chemotherapy, the role of maintenance chemotherapy with newer agents, such as docetaxel or paclitaxel, have not been established yet. Although Italian MANTA trial demonstrated no difference in PFS or survival between the two arms, their metaanalysis advocated survival benefit of maintenance therapy. Since gemcitabine/paclitaxel (GP) combination chemotherapy is one of the two regimens which showed definite survival gain with favorable toxicity from a randomized trial, we plan to randomize patients who responded to six cycles of GP induction chemotherapy to receive additional maintenance GP chemotherapy until disease progression versus observation. We hypothesize that patients who receive maintenance GP chemotherapy will do better in terms of progression free survival.

NCT ID: NCT00559845 Completed - Breast Cancer Clinical Trials

A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer

Start date: February 2008
Phase: Phase 2
Study type: Interventional

This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

NCT ID: NCT00559754 Completed - Breast Cancer Clinical Trials

A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.

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

This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle). They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.