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Breast Neoplasms clinical trials

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NCT ID: NCT01996267 Active, not recruiting - Breast Cancer Clinical Trials

Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2

TRAIN-2
Start date: December 2013
Phase: Phase 3
Study type: Interventional

This study compares two schedules of upfront chemotherapy in HER positive breast cancer.

NCT ID: NCT01996046 Active, not recruiting - Bone Metastases Clinical Trials

FDG PET/CT in Breast Cancer Bone Mets

Start date: September 2013
Phase:
Study type: Observational

This study will evaluate baseline uptake on a FDG PET/CT scan in patients with breast cancer that has spread to the bones. A repeat FDG PET/CT scan will be done 4 weeks after the start of new breast cancer hormone treatment and again at 12 weeks after treatment start. The baseline uptake and change in uptake after the repeat scans will be compared to clinical long term outcomes such as time to progression and overall survival. In addition the uptake will be compared to the incidence of skeletal related events that are common occurrences in patients with cancer that has spread to the bones.

NCT ID: NCT01992952 Active, not recruiting - Clinical trials for Estrogen Receptor Positive Breast Cancer

Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer

FAKTION
Start date: May 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a two stage study, with an initial dose escalation phase I study and subsequent double blind randomised phase II controlled trial. Eligible patients are post-menopausal women with metastatic ER+ breast cancer not suitable for surgical resection. Patients should be suitable for endocrine treatment, but have received no more than 3 previous lines of endocrine treatment and up to 1 line of chemotherapy for metastatic disease. They will also have had progressive disease during treatment with an aromatase inhibitor. Following the dose-escalation in stage 1, patients will be randomised to receive fulvestrant plus either placebo or 480mg (or maximum tolerated dose) of AZD5363 oral capsules or tablets taken once daily. Patients will receive fulvestrant in combination with either placebo or AZD5363 until disease progression. Patients may continue to receive fulvestrant and AZD5363/placebo treatment even after the last trial visit.

NCT ID: NCT01992432 Active, not recruiting - Breast Cancer Clinical Trials

Brain Functional MRI in Older Women With Breast Cancer (Brain fMRI-BC)

Brain fMRI-BC
Start date: September 30, 2013
Phase:
Study type: Observational

This study will use advanced MRI techniques to characterize the changes that occur to the structure and functionality of the brain in older breast cancer patients receiving adjuvant chemotherapy, and determine the relationship between the brain changes and severity of chemotherapy toxicity. Our results will be an early step towards identifying neuroimaging markers of aging, breast cancer and chemotherapy treatment, and will contribute to our understanding of the underlying pathophysiology of cognitive changes and chemotherapy toxicity in vulnerable, older adults with cancer. Furthermore, the work will lay the foundation for future, larger scale clinical studies of cognitive changes and chemotherapy toxicity in the aging cancer population.

NCT ID: NCT01957332 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer

IMPACT-MBC
Start date: August 30, 2013
Phase: N/A
Study type: Interventional

Current patient work-up, including conventional imaging and pathological assessment of just one single biopsy, might be insufficient to identify metastatic breast cancer patients, who possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion of the tumor is found quite frequently and molecular heterogeneity can occur within one patient, up-to-date whole body information is necessary to determine estrogen receptor (ER) and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently guide therapy decision. With molecular imaging via PET this information can be obtained in a non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular characterization of one metastasis at the beginning and, if feasible, of an additional biopsy during therapy, is necessary.

NCT ID: NCT01956409 Active, not recruiting - Clinical trials for Magnetic Resonance Imaging

Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis

Start date: September 2012
Phase: Phase 4
Study type: Interventional

The application of FCH PET in breast cancer diagnosis has not been reported. We hypothesize that FCH reveals choline metabolic profiles of breast cancers, and shows the similar pathophysiological mechanism to choline on proton MRS, and our study goals are: 1. To investigate and compare the diagnostic performance of proton MRS and FCH PET for localized findings on mammography and breast ultrasound. 2. To investigate whether FCH PET findings are correlated with choline signals on proton MRS. 3. To evaluate if choline, water and lipid signals on proton MRS, FCH PET are associated with factors related to clinical outcome and prognosis- that is, molecular markers, tumor staging, histologic grade of breast cancers. 4. For localized advanced breast cancer, to investigate the treatment response to NAC using proton MRS and FCH PET, and to evaluate which modality is more sensitive. 5. To investigate the usefulness of FCH PET for whole body staging for breast cancer patients.

NCT ID: NCT01953588 Active, not recruiting - Clinical trials for Stage IIIA Breast Cancer

Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery

Start date: December 13, 2013
Phase: Phase 3
Study type: Interventional

The study is being conducted to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug Administration (FDA) of the United States for use after surgery for postmenopausal women with estrogen receptor positive breast cancer. It is also considered a standard of care to give anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved by the FDA for use in women with early stage breast cancer before or after surgery, but is approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast cancer that has spread to other parts of the body.

NCT ID: NCT01943695 Active, not recruiting - Breast Cancer Clinical Trials

Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

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

The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer. The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.

NCT ID: NCT01937117 Active, not recruiting - Breast Cancer Clinical Trials

Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer

Start date: January 30, 2014
Phase: Phase 2
Study type: Interventional

This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.

NCT ID: NCT01937052 Active, not recruiting - Breast Cancer Clinical Trials

Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database

Start date: May 9, 2012
Phase:
Study type: Observational

The purpose of this project is to establish a repository of information and samples from breast cancer patients or those at high risk of developing breast cancer, who are initiating hormone therapy as part of standard clinical care or prevention. This repository will include patient reported outcomes and other questionnaires, information on medication use, data about adherence to the hormone therapy and tumor characteristics, including prospectively collected samples.