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Breast Neoplasms clinical trials

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NCT ID: NCT01633060 Terminated - Clinical trials for Metastatic Breast Cancer

A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

BELLE-3
Start date: October 3, 2012
Phase: Phase 3
Study type: Interventional

This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

NCT ID: NCT01628887 Terminated - Clinical trials for Stage IIIA Breast Cancer

Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

Start date: August 2012
Phase: N/A
Study type: Interventional

This clinical trial studies a supportive education program for Latina breast cancer survivors. The Bilingual Breast Cancer Education Intervention (BBCEI) may help Latina breast cancer survivors know what to expect after completing breast cancer treatment and prepare them to cope with cancer related survivorship issues

NCT ID: NCT01627067 Terminated - Breast Cancer Clinical Trials

Exemestane-RAD001-Metformin

Start date: September 2012
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if exemestane and everolimus combined with metformin can help to control breast cancer in patients who are obese or overweight and post-menopausal with hormone-receptor-positive breast cancer that has spread to other parts of the body. Exemestane is designed to decrease the ability of estrogen to help cancer cells grow. This could cause the cancer cells to die. Metformin is commonly used to control blood sugar levels in patients with diabetes. It is designed to lower insulin levels, which may slow or stop the growth of breast cancer cells. Everolimus is designed to block cells from dividing. This may cause cancer cells to die. Everolimus may also stop the growth of new blood vessels that help tumors grow.

NCT ID: NCT01623908 Terminated - Breast Neoplasms Clinical Trials

Bone Loss Treatment From Adjuvant Zoledronate Efficacy

BLAZE
Start date: July 2011
Phase: N/A
Study type: Interventional

The main purpose of this study is to observe and assess the impact of adjuvant zoledronate on bone density in breast cancer patients. The second purposes: - The efficacy of adjuvant zoledronate - The safety of adjuvant zoledronate - The bone loss of breast cancer patients in Guangdong - The correlation between bone loss of breast cancer patients and treatment of disease in Guangdong

NCT ID: NCT01616758 Terminated - Clinical trials for Metastatic Breast Cancer

Phase II Study of GTx024 in Women With Metastatic Breast Cancer

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

The primary efficacy analysis will be the clinical benefit at 6 months as measured by a modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary endpoints of objective response rate, progression free survival, time to progression, duration of response, effects on physical function, and effects on tumor progression in women with Androgen Receptor positive breast cancer will also be assessed.

NCT ID: NCT01614704 Terminated - Breast Cancer Clinical Trials

Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

Start date: October 2011
Phase:
Study type: Observational

Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than 40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have improved the prognostic of these patients. They will all most likely to received chemotherapy. Despite the fact that chemotherapy has many side effects, these women do question the impact of the treatment on their ability to procreate. On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility. Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports. Principal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential.

NCT ID: NCT01609920 Terminated - Breast Neoplasms Clinical Trials

Nodal Staging in Breast Cancer With MRL

Start date: May 2012
Phase: N/A
Study type: Interventional

The aim of this study is to examine the diagnostic performance of gadofosveset enhanced magnetic resonance imaging lymphography (MRL). The diagnostic performance of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be regarded as the golden standard for nodal involvement.

NCT ID: NCT01608451 Terminated - Clinical trials for Locally Advanced Breast Cancer and Large Operable Breast Cancer

Randomized Controlled Trial of Neo-adjuvant Progesterone and Vitamin D3 in Women With Large Operable Breast Cancer and Locally Advanced Breast Cancer

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

Randomized Controlled Trial of Neoadjuvant Progesterone and Vitamin D3 in women with Large Operable Breast Cancer and Locally Advanced Breast Cancer - A Feasibility Study Primary Progesterone Timing of surgery during the menstrual cycle and its impact on survival in premenopausal women with operable breast cancer has been extensively researched and reinvestigated by Badwe et al in the randomized clinical trial of 'Primary Progesterone Therapy for Operable Breast Cancer' at Tata Memorial Hospital. The underlying assumption was that the presence of unopposed estrogen (in follicular phase) at the time surgery may be deleterious for survival and that circulating progesterone might counteract this deleterious effect. Vitamin D3 The most prominent physiological role of hormonally active form of vitamin D3, 1,25-dihydroxyvitamin D3 (1,25(OH)2D3 or calcitriol), is regulation of calcium and phosphorous homeostasis and bone metabolism via an intracellular receptor (VDR) which is a member of steroid thyroid hormone super-family of receptors. The VDR receptors are also found in other tissues like breast and prostate. Vitamin D compounds have also been implicated in promotion of apoptosis in breast cancer cells and evidence suggests that 1,25(OH)2D3 and its synthetic analogues may potentiate responsiveness of breast cancer cells to conventional cytotoxic agents. Objectives 1. To see the effect of primary progesterone on survival in women with high risk breast cancer (large operable and locally advanced breast cancer) 2. To see the effect of Vitamin D3 as an antiproliferative, cytotoxic and apoptotic agent (negative growth regulator) by evaluation of surrogate markers of proliferation and apoptosis. Inclusion Criteria: - Unilateral breast cancer - Large operable breast cancer/LOBC (T3N0M0 or T3N1M0) and Locally advanced breast cancer/LABC (T3N1-2M0; T2N2M0) - Age <70 years - Fit for CT Exclusion Criteria: - Prior Incision Biopsy or Excision Biopsy - Metastatic breast cancer - Renal failure or deranged Renal Function Test - Hypoparathyroidism - Pregnant or lactating mothers or women of childbearing age not practicing contraception - Patient on any of the following drugs: Magnesium-containing antacids, Digitalis, Phenytoin barbiturates, Thiazide diuretics. - Previous history of other cancers except cured skin and cervical carcinoma in situ. Methodology / Treatment plan The study drugs (Injectable Progesterone and Vitamin D3) will be tested in the neoadjuvant setting prior to administration of each chemotherapy cycle, in a 2x2 factorial design as below: Neoadjuvant D3 will be administered as Inj. Arachitol 300,000 IU/ml intramuscular, before each chemotherapy cycle. Neoadjuvant Progesterone used will be administered as single IM depot injection 500mg 5 days prior to each CT cycle and surgery date. Primary Objectives Disease-free survival Secondary Objectives Improvements in overall survival Tumor response

NCT ID: NCT01598285 Terminated - Clinical trials for Breast Cancer Invasive Nos

A Combined GWAS and miRNA for the Identification of Bevacizumab Response Predictors in Metastatic Breast Cancer

Start date: April 18, 2012
Phase:
Study type: Observational

GEI-BEV-2011-01 is an Observational multicenter study. The study, involving 200 (100 non-responders and 100 best responders) metastatic breast cancer patients, will search for specific genetic variants (SNPs) and miRNA signatures associated with bevacizumab response. Only patients suffering from metastatic (disseminated at the time of diagnosis) breast cancer, treated with bevacizumab, will be included. 1. -To identify genetic variants as bevacizumab response predictors in metastatic breast cancer 2. To identify miRNA signatures in whole blood as bevacizumab response predictors in metastatic breast cancer patients. The main endpoint will be progression-free survival (PFS) The duration of the study will be approximately 18 months

NCT ID: NCT01597921 Terminated - Breast Cancer Clinical Trials

A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer

Start date: May 2012
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.