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Breast Neoplasms clinical trials

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NCT ID: NCT01772472 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

Start date: April 3, 2013
Phase: Phase 3
Study type: Interventional

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

NCT ID: NCT01771666 Completed - Breast Cancer Clinical Trials

Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer

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

The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.

NCT ID: NCT01771549 Completed - Breast Cancer Clinical Trials

Kinetics of Troponin and BNP in Breast Cancer Chemotherapy With Adriamycin and Trastuzumab

Start date: January 2013
Phase:
Study type: Observational

This pilot study involves very frequent monitoring of breast cancer patient blood levels of hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are frequently elevated after experimental chemotherapy in animal models. Their behavior in humans has been inconsistent, with occasional elevations seen, usually within 30 days of therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced. A majority of patients greater than age 50 have elevations above the detection limit, compared to only 1-3% with conventional troponin assays, and over 90% of diabetics have elevations above the detection limit. Moreover, augmented release of high sensitivity troponin is detected after exercise or rapid atrial pacing of durations of 10-15 minutes in patients with and without coronary artery disease. This improved sensitivity suggests the potential for detection and monitoring of cardiac damage after cancer chemotherapy. We hypothesized that this new generation of troponin assay would be associated with kinetic behavior suggesting ongoing cardiac damage with anthracycline therapy, and possibly also with trastuzumab.

NCT ID: NCT01770353 Completed - Solid Tumors Clinical Trials

MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment

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

This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.

NCT ID: NCT01769625 Completed - Clinical trials for Biomarker Change Linked to Breast Cancer

Changes in Biomarkers Using Prostaglandin Inhibitors

Start date: January 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease. The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.

NCT ID: NCT01766297 Recruiting - Breast Cancer Clinical Trials

Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

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

The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.

NCT ID: NCT01765049 Active, not recruiting - Clinical trials for Invasive Breast Cancer

Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor

DEAR
Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

Breast density change after short term use of aromatase inhibitor in postmenopausal ER positive breast cancer would predict endocrine responsiveness

NCT ID: NCT01764802 Completed - Breast Cancer Clinical Trials

Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer

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

This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual and psychosocial function.

NCT ID: NCT01764789 Completed - Depression Clinical Trials

Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer

Start date: October 2010
Phase: N/A
Study type: Interventional

This pilot clinical trial studies stress reduction in improving quality of life in patients with recurrent gynecologic or breast cancer. Participating in a stress reduction program may help improve quality of life in patients with gynecologic or breast cancer.

NCT ID: NCT01764022 Completed - Clinical trials for Human Epithelial Receptor (HER)-2 Positive Breast Cancer

A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients

Start date: October 2012
Phase: Phase 3
Study type: Interventional

BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes pharmacokinetics assessment.