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Breast Neoplasms clinical trials

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NCT ID: NCT01079676 Completed - Clinical trials for Neutropenia in Breast Cancer

A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.

NCT ID: NCT01077726 Completed - Breast Cancer Clinical Trials

A Study of Xeloda (Capecitabine) in Breast Cancer Patients With Central Nervous System (CNS) Progression

Start date: January 2010
Phase: Phase 2
Study type: Interventional

This single arm study will assess the efficacy of Xeloda in the treatment of brain metastases in breast cancer patients with central nervous system (CNS) progression after whole brain radiotherapy. Patients will receive xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

NCT ID: NCT01077453 Completed - Clinical trials for Healthy, no Evidence of Disease

Letrozole in Preventing Breast Cancer in Healthy Postmenopausal Women at High Risk for Breast Cancer

Start date: March 2010
Phase: Phase 1
Study type: Interventional

This randomized phase I trial studies the side effects and the best dose of letrozole in preventing breast cancer in healthy postmenopausal women at high risk for breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of letrozole may keep cancer from forming in healthy postmenopausal women at high risk for breast cancer.

NCT ID: NCT01077154 Terminated - Breast Cancer Clinical Trials

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

Start date: June 2, 2010
Phase: Phase 3
Study type: Interventional

This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.

NCT ID: NCT01075802 Completed - Breast Cancer Clinical Trials

Study of Tamoxifen Dose Escalation in Breast Cancer Patients With CYP2D6 Polymorphisms

TADE
Start date: March 2010
Phase: N/A
Study type: Interventional

Tamoxifen is an important drug for the treatment of breast cancer. Used adjuvantly after operation in early breast cancer, tamoxifen reduces annual recurrence rate by half and cancer death by one third. Used preventatively it also reduces the risk of breast cancer by 50% in women at high risk for developing the disease Tamoxifen needs to be activated in the body to an active form called endoxifen, mainly by the enzyme called CYP2D6. Patients have variable capability to activate tamoxifen due to variable function of this enzyme. Studies showed clear correlation of specific genetic variant of CYP2D6 with endoxifen blood levels. It is estimated that up to 25% Caucasian population have reduced or even absent CYP2D6 function. More recently, there were studies that showed the correlation with genetic variant of CYP2D6 and breast cancer relapse in early breast cancer patients treated with tamoxifen. Food and Drug Authority (FDA) in America and recommended checking CYP2D6 genotype in patients receiving tamoxifen treatment, but they did not specify how to interpret the genotype results and what kind actions to take in patient with adverse genotype. The aim of the investigators study is to see if increasing tamoxifen in patients with genetic polymorphism of CYP2D6 will increase endoxifen level to the same range of most patients who have wild type (normal functional)CYP2D6.

NCT ID: NCT01075607 Terminated - Clinical trials for Adenocarcinoma of the Breast

Lymph Fluid and Blood Collection for Identification of Novel Biomarkers

Start date: April 2010
Phase: N/A
Study type: Observational

The objective of this study is to identify and validate metastasis protein markers in lymph collected from women with metastatic breast cancer. We will examine peripheral blood for the presence of these identified markers in order to develop a user friendly clinical test to detect metastasis and to evaluate response to therapy.

NCT ID: NCT01075100 Completed - Clinical trials for Metastatic Breast Cancer

Ixabepilone + Carboplatin Metastatic Breast Cancer

Start date: January 2010
Phase: Phase 2
Study type: Interventional

Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. Carboplatin in combination with gemcitabine or paclitaxel has activity in metastatic breast cancer (MBC); there is also demonstrated activity of the gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of this combination at the doses and schedule proposed for this Phase II trial (BMS data on file).

NCT ID: NCT01074970 Completed - Breast Cancer Clinical Trials

PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations

Start date: February 2010
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy. Side effects and tolerability of this treatment in patients with residual disease following preoperative chemotherapy will also be observed and characterized.

NCT ID: NCT01074814 Completed - Clinical trials for Metastatic Breast Cancer

Pilot Study Using Molecular Profiling to Find Potential Targets & Select Treatments for Pts With Met br ca

Side-Out
Start date: March 2010
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to determine the response rate, that is the % of patients with non-progression of their metastatic breast cancer after 4 months on treatment that was selected by molecular testing and proteomics.

NCT ID: NCT01073865 Completed - Breast Cancer Clinical Trials

Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer

Start date: February 26, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.