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Breast Neoplasms clinical trials

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NCT ID: NCT01712009 Completed - Clinical trials for Bone Pain in Stage I - III Breast Cancer

NOLAN: Naproxen or Loratadine and Neulasta

NOLAN
Start date: November 1, 2012
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.

NCT ID: NCT01711502 Completed - Clinical trials for Breast Cancer Nos Metastatic Recurrent

Epidemiology and Management of Metastatic Breast Cancer

Start date: January 2013
Phase: N/A
Study type: Observational

This is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . The main purpose of this study is to provide accurate, evidence based description on the incidence of progression of metastatic breast cancer and its clinical management.

NCT ID: NCT01707121 Completed - Physical Activity Clinical Trials

The Impact of Physical Activity on the Outcome of Surgery

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

Over the last decades different life style factors have been established as risk factors for various diseases. The obesity pandemic displays a good example of a disease where great effort is undertaken to characterize risk factors associated with obesity (1). Smoking is another life style risk factor established since several decades, and where primary prevention has been increasingly successful (2, 3). Cardiovascular epidemiologic research at the University of Gothenburg recognized PA as a factor of importance early on and thus included PA related questions in the work up of studies with large cohorts (4-6). A 4-level scale was introduced in the late 1960:s by Saltin and Grimby (7) and has been used extensively since then. With this background it is of interest to record physical activity one year and one month prior to certain types of elective surgery and to study the relationship of PA to surgical complications and recovery is of interest. The aim of this study is to investigate whether a higher physical activity prior to a surgical procedure reduces hospital stay, sick leave and the complication rate. A secondary aim is to investigate the effect of preoperative physical activity on the rate of resumption of QoL and normal physical function.

NCT ID: NCT01706016 Completed - Breast Cancer Clinical Trials

Local Treatment by Thermic Destruction of Primitive Breast Cancer

LASERBREAST1
Start date: October 9, 2012
Phase: Phase 2
Study type: Interventional

Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser

NCT ID: NCT01705691 Completed - Breast Cancer Clinical Trials

Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer

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

NSABP FB-9 is a Phase II, multi-center, randomized study of eribulin or weekly paclitaxel followed by doxorubicin and cyclophosphamide (AC) as neoadjuvant therapy for women with HER2-negative, operable and locally advanced breast cancer (stage IIb and III). Patients in the control arm will receive neoadjuvant weekly paclitaxel (WP) followed by AC. The primary aim of the study is to determine the pathologic complete response (ypCR) in breast and axillary lymph nodes following completion of neoadjuvant therapy. The secondary aims include determination of the ypCR in axillary nodes, clinical complete response (ycCR) rate after eribulin or paclitaxel and after completion of neoadjuvant chemotherapy, two-year recurrence-free interval, two-year overall survival, and toxicity of the neoadjuvant regimens.

NCT ID: NCT01704547 Completed - Breast Cancer Clinical Trials

Breast Cup Immobilization Device II (GCC 1047)

BCID II
Start date: October 2012
Phase:
Study type: Observational

The study is designed to assess the accuracy of patient breast reproducibly using the revised BCID. This study would provide data for target verification and quality assurance to eventually allow treatment of breast cancer patients for either a TBB or accelerated partial breast irradiation. The BCID is a low-risk device similar to immobilization devices used routinely in radiotherapy for other disease sites.

NCT ID: NCT01703754 Completed - Clinical trials for Breast Cancer Nos Metastatic Recurrent

Adenoviral Vector Monotherapy or Combination With Chemotherapy in Subjects With Recurrent/Metastatic Breast Cancer.

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

Phase II, randomized, safety and efficacy study in recurrent/metastatic breast cancer with accessible lesions. Primary End point is rate of Progression Free Survival (PFS) at the 16 week treatment time point. Hypothesis: Adenoviral vector (Ad-RTS-hIL-12) alone and in combination with chemotherapy (palifosfamide) is safe and efficacious.

NCT ID: NCT01703520 Completed - Male Breast Cancer Clinical Trials

Finasteride (MK-0906) and Male Breast Cancer - A Register-Based Nested Case-Control Study (MK-0906-162/2003.021).

Start date: May 1, 2011
Phase:
Study type: Observational

The objective of this study is to investigate the potential association between finasteride (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden, Finland, and Norway from data in national registries. The primary hypothesis of this study is that the previously reported increased incidence of male breast cancer among finasteride users is explained by confounding factors.

NCT ID: NCT01702571 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

Start date: November 27, 2012
Phase: Phase 3
Study type: Interventional

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

NCT ID: NCT01701050 Completed - Clinical trials for Metastatic Breast Cancer

Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index

COMETI P2
Start date: April 1, 2013
Phase: N/A
Study type: Observational

Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly characterize circulating tumor cells (CTC) for tumor markers that predict endocrine sensitivity (estrogen receptor [ER] and Bcl-2) and resistance (HER2 and Ki67) has been demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed that can be calculated for each patient using the CTC enumeration and marker results. The primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic breast cancer patients before the initiation of a new endocrine therapy for the identification of patients that will progress rapidly.