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Breast Neoplasms clinical trials

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NCT ID: NCT02118636 Completed - Breast Cancer Clinical Trials

Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms

Start date: October 2009
Phase: N/A
Study type: Observational

Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. This observational study is designed to collect patient-reported outcomes and serial serum samples in order to investigate potential etiologies of this bothersome toxicity.

NCT ID: NCT02117011 Completed - Breast Cancer Clinical Trials

Effects of a Structured Exercise Program on Cancer-Related Fatigue in Women Receiving Radiation Therapy for Breast Cancer

Start date: June 2013
Phase: N/A
Study type: Interventional

Radiation therapy (RT) is often used to treat breast cancer. RT combined with breast surgery is associated with better outcomes in early stage breast cancer compared to surgery alone. Fatigue is one of the most important side effects of RT because it can decrease patients' quality of life. Studies found that physical activity (PA) may help to improve quality of life in cancer survivors. PA has been reported to lower fatigue, anxiety, and depression. Physical inactivity over a long period of time may lead to rapid energy and physical function loss. PA intervention studies in patients undergoing RT have included mostly White patients. There is no evidence on African American patients undergoing RT. The purpose of this study is to examine the efficacy of a structured, moderate-intensity, aerobic exercise program in reducing cancer-related fatigue in African Americans undergoing RT for localized breast cancer.

NCT ID: NCT02115984 Completed - Breast Cancer Clinical Trials

Study of the Safety and Leukostimulatory Activity of the Preparation "Panagen" in Patients With Breast Cancer

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The goal of this trial is to assess the safety, therapeutic dose, and leukostimulatory activity of the preparation Panagen in the therapeutic schemes for treating cancer diseases in the patients receiving a standard chemotherapy for breast cancer of stages II-IV (with distant metastases).

NCT ID: NCT02115607 Completed - Breast Cancer Clinical Trials

Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

Start date: March 2014
Phase: N/A
Study type: Interventional

This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to MRI and pathology.

NCT ID: NCT02115594 Withdrawn - Breast Cancer Clinical Trials

Phase 2 Study of Fulvestrant With and Without Entinostat in Postmenopausal Women With ER+ Advanced Breast Cancer

ENCORE305
Start date: April 2014
Phase: Phase 2
Study type: Interventional

Preclinical data has demonstrated that entinostat (SNDX-275) can enhance fulvestrant sensitivity in hormone receptor-positive breast cancer in animal models. The addition of entinostat to fulvestrant will provide clinical benefit to patients with locally advanced or metastatic breast when compared to fulvestrant plus placebo. Also, based on previous data, patients exposed to entinostat who demonstrate an elevated level of protein lysine acetylation will have an improved efficacy outcome.

NCT ID: NCT02115282 Active, not recruiting - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic

Start date: March 29, 2014
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or another place in the body (metastatic). Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.

NCT ID: NCT02115204 Completed - Breast Cancer Clinical Trials

4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF

Start date: June 2000
Phase: Phase 3
Study type: Interventional

Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West German Study Group and "Arbeitsgemeinschaft Gynäkologische Onkologie" (WSG-AGO) EC-Doc is a large trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3 involved lymph nodes (LN).

NCT ID: NCT02115152 Not yet recruiting - Clinical trials for Stage II Breast Cancer

Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer

Start date: June 2014
Phase: Phase 2
Study type: Interventional

This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC).

NCT ID: NCT02115048 Terminated - Breast Neoplasms Clinical Trials

Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study is to compare the efficacy of treatment with afatinib plus letrozole to treatment with letrozole alone in women diagnosed with a specific type of breast cancer.

NCT ID: NCT02113553 Terminated - Breast Cancer Clinical Trials

Anti-Mullerian Hormone (AMH) as Marker of Ovarian Reserve

Start date: May 2013
Phase: Phase 2
Study type: Interventional

This is a multicentre, prospective study willing to evaluate AMH levels changes in response to chemotherapy plus GnRHa. In the present study we propose to determine AMH levels in breast cancer patients, aged <40yrs receiving adjuvant chemotherapy and ovarian suppression by means of GnRHa with the aim to assess the role of AMH as surrogate marker of the preservation of ovarian reserve exerted by GnRHa.