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Breast Neoplasms clinical trials

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NCT ID: NCT02263495 Completed - Clinical trials for Metastatic Breast Cancer

Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer

EG_PG
Start date: December 19, 2014
Phase: Phase 2
Study type: Interventional

Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective chemotherapy. Paclitaxel plus Gemcitabine (PG) combination chemotherapy is one of the preferred chemotherapeutic regimens for patients with MBC, and was found to be proper as a maintenance chemotherapy regimen with survival benefit and feasible toxicity profile as shown in a large phase III KCSG (Korean Cancer Study Group) study (Park Y et al. J Clin Oncol 31(14):1732, 2013). Eribulin mesylate is a microtubule-targeting agent that showed improved overall survival benefit as monotherapy for MBC patients as a new chemotherapeutic agent after failure of anthracycline and taxane in EMBRACE study (Cortes J et. al. Lancet 377:914-923, 2011). Eribulin was also reported its promising efficacy in another randomized phase III study that demonstrated eribulin as efficacious as capecitabine (Kaufman P et. al. Abstr# S6-6, SABCS 2012). Both study results showed potential clinical benefit in patients with triple negative MBC (TNBC). Thus, eribulin combined with gemcitabine may be a new potential regimen for early line therapy in patients with metastatic breast cancer. Furthermore, eribulin may have rational benefit compared with paclitaxel in terms of neurotoxicity. Although there is no direct evidence that eribulin has better neurotoxicity profile than taxane, eribulin tended to show less neurotoxicity compared with ixabepilone in a phase II trial (Vahdat, L et al. 2011 SABCS). Eribulin has no worsen toxicity as compared to paclitaxel. Therefore, EG may have less neurotoxicity comparing to PG. In phase I trial, eribulin in combination with gemcitabine was feasible in patients with advanced solid tumor treated with chemotherapy (< 3 lines) (Goel R, et al, 2009 ASCO). Based on this rationale, the investigators are to conduct randomized phase II study comparing EG chemotherapy with PG chemotherapy for patients with HER-2 negative MBC as first-line chemotherapy. A total of 118 patients will be recruited. Patients will be randomized to a treatment arm by permutated method. The randomization ratio is 1:1. This study is multi-center, randomized, open label study.

NCT ID: NCT02263014 Completed - Breast Cancer Clinical Trials

Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)

Start date: February 24, 2014
Phase:
Study type: Observational

The goal of this research study is to learn more about how different treatment decisions may influence the quality of life in women with breast cancer. Researchers want to use what is learned from this study to help future patients with breast cancer to be more informed when making treatment decisions.

NCT ID: NCT02261389 Active, not recruiting - Breast Cancer Clinical Trials

Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET

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

The main purpose of follow-up in asymptomatic breast cancer patients during and after adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA and CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a critical increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast cancer local and distant recurrence compared to the usual follow-up practice.

NCT ID: NCT02260661 Completed - Clinical trials for Advanced Solid Malignancies

Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours

Start date: November 2014
Phase: Phase 1
Study type: Interventional

First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is administered as a single agent in a multiple ascending dose escalation phase to investigate dose level for monotherapy. Part B follows the multiple ascending dose phase, additional patients with tumors with documented PIK3CA gene mutation will be enrolled to a single dose expansion phase. Part C is a second dose escalation phase in which post-menopausal patients with estrogen receptor positive (ER+), HER2 negative breast cancer will receive AZD8835 in combination with fulvestrant. Part D follows the combination dose escalation phase of the study, additional postmenopausal patients with ER+/HER2 negative breast cancer with documented PIK3CA gene mutation will be enrolled to a AZD8835 and fulvestrant combination dose-expansion phase at maximum tolerated dose or recommended phase II dose.

NCT ID: NCT02260531 Completed - Breast Cancer Clinical Trials

Cabozantinib +/- Trastuzumab In Breast Cancer Patients w/ Brain Metastases

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

This research study is evaluating the effectiveness of the drug called cabozantinib (alone or in combination with trastuzumab) as a possible treatment for advanced breast cancer in which the cancer has spread to the brain.

NCT ID: NCT02258464 Terminated - Breast Neoplasms Clinical Trials

Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

Start date: March 2, 2015
Phase: Phase 2
Study type: Interventional

The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy

NCT ID: NCT02258451 Completed - Breast Neoplasms Clinical Trials

Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer

Start date: June 4, 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.

NCT ID: NCT02257775 Terminated - Clinical trials for Metastatic Breast Cancer

Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer

EVOLUTION
Start date: May 11, 2015
Phase: N/A
Study type: Observational

The objective of this study is to apply Whole-body DW imaging alongside the routine management of patients requiring systemic therapy for metastatic breast cancer to compare the time to progression of individual liver metastases within and between patients following stable disease or partial response to palliative systemic therapy for breast cancer.

NCT ID: NCT02256670 Completed - Breast Cancer Clinical Trials

Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial

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

Pilot study to assess feasibility and patient acceptance of a text message cell phone application for patients with stage I-III, hormone receptor positive breast cancer who start adjuvant endocrine therapy.

NCT ID: NCT02255240 Withdrawn - Breast Cancer Clinical Trials

LEVEL UP: Video Games for Activity in Breast Cancer Survivors

LEVEL UP
Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to test an intervention that uses home console video games to encourage increased physical activity among postmenopausal breast cancer survivors.