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Metastatic Breast Cancer clinical trials

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NCT ID: NCT02384239 Completed - Clinical trials for Metastatic Breast Cancer

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

Start date: October 19, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant or tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving palbociclib together with fulvestrant or tamoxifen citrate may work better in treating hormone receptor positive breast cancer.

NCT ID: NCT02383030 Recruiting - Clinical trials for Metastatic Breast Cancer

Fulvestrant as Maintenance Therapy After First-line Chemotherapy in HER2 - Postmenopausal MBC Patients

FUMANCE
Start date: November 2015
Phase: Phase 3
Study type: Interventional

Breast cancer is one of the most prevalent cancers among women, and represents 20 - 25% of all female cancers. Despite earlier diagnosis and improvement in adjuvant therapies, some patients will present metastatic recurrence. Treatment of breast cancer is determined by the extent of the disease. Early or localized breast cancer is treated by a combination of surgery and radiotherapy. Adjuvant systemic therapy, consisting of chemotherapy and/or endocrine therapy, in tumors deemed hormone responsive, can prolong the disease-free interval and improve overall survival. However, approximately 30% to 40% of patients with early breast cancer will ultimately relapse, with either local recurrence or distant metastases, and require further systemic treatment for advanced disease. Since breast cancer that recurs or progresses after initial treatment is considered incurable, the therapy options available for advanced disease are concerned with disease control and palliation of symptoms. Hormonal therapy has become the treatment of choice in postmenopausal women with hormone sensitive breast cancer. Even though the treatment of advanced breast cancer in postmenopausal women has improved with the introduction of agents such as aromatase inhibitors, these agents still have limitations, and disease management continues to be sub-optimal. The use of systemic therapies such as hormonal therapy, chemotherapy or new biological treatment is to reduce tumour masses, improve survival and preserve quality of life. Whatever the initial efficacy of the treatment undertaken in metastatic setting, almost every patient will relapse. The main goal is to improve progression free survival (PFS). To achieve this, the type of chemotherapy, the optimal duration of chemotherapy, the benefit of maintenance chemotherapy, the benefit of maintenance hormonal treatment are debatable.

NCT ID: NCT02370238 Completed - Clinical trials for Metastatic Breast Cancer

A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer

FRIDA
Start date: July 29, 2015
Phase: Phase 2
Study type: Interventional

The Objectives of this study: The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occured first) in patients with metastatic triple-negative breast cancer (TNBC) treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone. The secondary objectives were: - To determine overall survival (OS). - To evaluate objective response rates (ORR). - To determine median PFS (mPFS). - To assess the safety of the combination of paclitaxel and orally administered reparixin (referred to as combination treatment).

NCT ID: NCT02365831 Recruiting - Clinical trials for Metastatic Breast Cancer

Observation of Medical Treatments in MBC HER2-negative Patients

AMBRA
Start date: May 2015
Phase: N/A
Study type: Observational

While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a standard strategy for HER2-negative tumors. Because of lack of information related to the the factors affecting the choice of a particular treatment strategy, as well as the optimization of the correct sequence of treatments, the choice of the treatment for the advanced disease remains highly empirical and may differ significantly among the different cancer centers. The purpose of this study is the observation of a cohort of patients with metastatic HER2-negative in terms of: 1. the choice of chemotherapy treatments starting from the first line of treatment; 2. factors that may influence these choices; 3. correlation among the characteristics of patients (age, menopausal status, etc.) and type of adjuvant and metastatic treatment ; 4. clinical outcome (pattern of relapse, time from diagnosis, etc.); 5. evaluation of the adherence to the literature's recommendations for therapeutic sequences in clinical practice.

NCT ID: NCT02362230 Terminated - Clinical trials for Metastatic Breast Cancer

Evaluation of Icotinib in Metastatic Triple-negative Breast Cancer After Second-line Therapy

Start date: January 2015
Phase: Phase 2
Study type: Interventional

Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments.

NCT ID: NCT02361112 Completed - Clinical trials for Metastatic Breast Cancer

Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer

BLTN-Ic
Start date: August 2014
Phase: Phase 1
Study type: Interventional

Pyrotinib is an oral tyrosine kinase inhibitor targeting both EGFR and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer: To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD) To determine the dose-limiting toxicity (DLT) To determine the pharmacokinetic profile of Pyrotinib To assess preliminary antitumor activity To determine preliminary regimen dose for phase II study

NCT ID: NCT02344550 Completed - Clinical trials for Metastatic Breast Cancer

Study of GnRH-A [Leuprorelin(Lorelin Depot] Plus Leterozole +/- Everolimus for Premenopausal Women With Metastatic Breast Cancer

LEO
Start date: January 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of addition of everolimus to letrozole with LHRH agonist in premenopausal metastatic breast cancer patients who failed to tamoxifen treatment.

NCT ID: NCT02344472 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Detect V / CHEVENDO (Chemo vs. Endo)

Start date: September 2015
Phase: Phase 3
Study type: Interventional

Chemo- versus endocrine therapy in combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus Kisqali® (ribociclib) in patients with HER2 positive and hormone-receptor positive metastatic breast cancer.

NCT ID: NCT02338245 Completed - Clinical trials for Metastatic Breast Cancer

Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab

Start date: December 29, 2014
Phase: Phase 2
Study type: Interventional

This is an open-label, randomized, parallel group Phase 2A/2B study to evaluate the clinical activity of ASLAN001 in combination with capecitabine compared with lapatinib in combination with capecitabine in patients with HER2 positive metastatic breast cancer that has failed on prior trastuzumab therapy.

NCT ID: NCT02329639 Recruiting - Clinical trials for Metastatic Breast Cancer

Prospective Study of VEGFR-2 /IL-8 Genetic Interaction in MBC Treated With Paclitaxel and Bevacizumab vs. Chemotherapy

BEVAPROS
Start date: April 2014
Phase: N/A
Study type: Observational

Metastatic Breast cancer (MBC) patients from ten Italian Divisions of Medical Oncology, with histologically confirmed HER2-negative MBC, treated with a first-line therapy including bevacizumab 10 mg/m2 i.v. on days 1 and 15 combined with first-line paclitaxel 90 mg/m2 i.v. on days 1,8 and 15, every 4 weeks, will be enrolled for the present pharmacogenetic study. MBC patients treated with first-line chemotherapy including paclitaxel without bevacizumab will be also enrolled as control group.