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Metastatic Breast Cancer 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: NCT01627704 Completed - Clinical trials for Metastatic Breast Cancer

Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer

ESTROTEPREDIC
Start date: June 2012
Phase: N/A
Study type: Interventional

Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.

NCT ID: NCT01626222 Completed - Clinical trials for Metastatic Breast Cancer

4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer

MACS2096
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The present multi-center, open-label, single-arm study aims to evaluate the efficacy and safety, quality of life and health resources utilization in postmenopausal women with hormone receptor positive breast cancer progressing following prior therapy with non-steroidal aromatase inhibitors (NSAI) treated with the combination of Everolimus and Exemestane.

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: NCT01611727 Completed - Clinical trials for Metastatic Breast Cancer

Open-Label,Non-Randomized Trial of Cisplatin Chemotherapy in BRCA1-Positive Metastatic Breast Cancer Patients

Cisplatin
Start date: July 2007
Phase: Phase 2
Study type: Interventional

Among women with a BRCA1 mutation and breast cancer, choice of chemotherapy is a critical issue. There are emerging data which suggest that mutation carriers may respond differently than non-carriers to particular agents. BRCA1-associated cancers differ from non-hereditary cancers for a range of pathologic and molecular factors, including tumor grade and histologic appearance. Several studies have shown that the response to treatment for women with a BRCA1-associated breast cancer reflects the underlying tumor biology, in particular, the impairment of the DNA damage response and repair pathways, and that it is possible to exploit the sensitivity of BRCA1-associated cancers to DNA damage. It is equally important that the investigators evaluate the benefit of cisplatin in women with disseminated breast cancer, including those who have previously been treated with one or more chemotherapy regimens. This study is undertaken to evaluate the efficacy of cisplatin chemotherapy in BRCA1 carriers with metastatic breast cancer. The primary objective is to determine the objective response rate of cisplatin in BRCA1 carriers with metastatic breast cancer. The secondary objectives are to determine 3-year survival and to evaluate the toxicities of cisplatin in BRCA1 carriers with metastatic breast cancer.

NCT ID: NCT01609127 Recruiting - Clinical trials for Metastatic Breast Cancer

Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer

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

This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.

NCT ID: NCT01596751 Completed - Clinical trials for Metastatic Breast Cancer

Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer

Start date: July 12, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the Phase 1b portion of the study is to determine the best dose of PLX3397 when given in combination with standard dose eribulin (Halaven™). The purpose of the Phase 2 portion of the study is to find out what effects, good and/or bad, these drugs have on patients and their metastatic breast cancer.

NCT ID: NCT01589159 Completed - Clinical trials for Metastatic Breast Cancer

A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes

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

This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and safety study. Eligible patients are enrolled in a single group. The investigators propose to determine the efficacy and safety of low-dose metronomic chemotherapy with Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and/or Taxanes.

NCT ID: NCT01576666 Completed - Gastric Cancer Clinical Trials

Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors

Start date: July 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies. This study will also learn more about how the combination of these two investigational drugs may work for patients with certain cancers (specifically metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma multiforme).

NCT ID: NCT01555944 Completed - Clinical trials for Metastatic Breast Cancer

Prospective Observational Study in Patients With Metastatic Breast Cancer Treated With Anthracyclines

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

This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium. Principal objectives: 1. To evaluate the prevalence of cardiovascular risk factors and cardiac function (as routinely evaluated) before treatment with anthracyclines of patients with metastatic breast cancer (MBC) aged > or = 65 years 2. To observe the management of cardiovascular risk during and after anthracycline treatment 3. To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30) Secondary objectives: 1. To evaluate the efficacy of anthracyclines on progression free survival and tumor response as routinely measured (e.g. recist criteria, tumor markers and other exams) 2. To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment. 3. To find out how quality of life, e.g. such as described according to EORTC QLQ-C30 criteria or Karnofsky index is achieved in the various patient subgroups 4. To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline 5. To calculate the cardiovascular risk according to SCORE