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NCT ID: NCT01403779 Completed - Breast Cancer Clinical Trials

Comparison of the Cosmetic Outcome of Hypofractionated Versus Normofractionated IMRT in Treatment of Breast Cancer

KOSIMA
Start date: July 2010
Phase: Phase 3
Study type: Interventional

Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and normofractionated radiotherapy after breast-conserving surgery. However, the treatment in these studies was carried out with conventional techniques and not with the modern IMRT. Also the evaluation of quality of life and cosmetic outcome were not standardized. This study is a two-arm prospective study comparing normofractionated and hypofractionated radiotherapy in patients with breast cancer using tangential IMRT techniques. The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint is the patients' quality of life. Patients to be included are breast cancer 60 years old patients or older with tumour stages pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy). In both groups, a tangential intensity-modulated radiation technique aiming to achieve optimal dose homogeneity is applied. Since higher single radiation dose to the heart can lead to higher morbidity and/or mortality, patient stratification according to the diseased side was adopted where the left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore there is no randomization. For classification and grading of adverse cosmetic events, the "Common Toxicity Criteria (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of life is to be documented with two standardized, validated questionnaires "QLQ C30 and BR23" of the EORTC (European Organization for Research and Treatment of Cancer). The questionnaires are to be filled by the patients themselves at different time points during the study period. A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of around 20% is expected after 2 years. Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the need for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated therapy).

NCT ID: NCT01403688 Completed - Breast Cancer Clinical Trials

Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin

Start date: June 2011
Phase: N/A
Study type: Observational

Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA). The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.

NCT ID: NCT01400438 Completed - Breast Cancer Clinical Trials

Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer

HER-ception
Start date: July 2011
Phase: N/A
Study type: Interventional

Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. Curiously, no study to date has been submitted or published about how women with a one-year treatment "extra" Herceptin ® live this period in terms of quality of life, in terms of psychological impact for themselves and their families. The investigators have no more data on how often they return to work during this treatment or on the psycho-social parameters which underpin them. It therefore seemed interesting to "give a spotlight" on this particular period in these women HER2 + by comparing a patient population of same age receiving the same adjuvant but with no Herceptin ®.

NCT ID: NCT01399359 Completed - Breast Cancer Clinical Trials

Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer

Start date: August 2011
Phase:
Study type: Observational

RATIONALE: Learning about how patients make decisions about using chemoprevention may help doctors plan treatment in which more patients are willing to choose chemoprevention to reduce their breast cancer risk. PURPOSE: This clinical trial studies factors influencing decision-making about the use of chemoprevention in women at increased risk for breast cancer.

NCT ID: NCT01399086 Completed - Breast Cancer Clinical Trials

Fulvestrant in Postmenopausal Patients With Metastatic Breast Cancer

Start date: April 2011
Phase: N/A
Study type: Observational

This is a retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on patients who have commenced treatment with fulvestrant after January 1st of 2007. All necessary information for the purposes of the present study will be collected with the use of a paper-Case Record Form.

NCT ID: NCT01396655 Completed - Breast Cancer Clinical Trials

PET in Breast Cancer Receiving Neoadjuvant Chemotherapy

DA-PET
Start date: July 2006
Phase: Phase 2
Study type: Interventional

Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer. The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by neoadjuvant chemotherapy.

NCT ID: NCT01395459 Completed - Breast Cancer Clinical Trials

A Sustainable Approach to Increasing Cancer Screening

CATCH
Start date: September 2008
Phase: N/A
Study type: Interventional

Parent study: A Coordinated Approach to Cancer and Health (CATCH), was designed to compare the efficacy of two intervention arms (described below) intended to increase breast, cervical, and colon cancer screening rates among patients served by community health centers. A central focus of CATCH is to evaluate sustainable strategies for maximizing cancer screening rates among populations facing significant cancer disparities. CATCH was conducted in partnership with the large health clinic in Massachusetts, which serves a largely Hispanic low income population. Focusing on the use of an Interactive Voice Response (IVR) telephone technology system, the study is examining the extent to which the IVR, when developed in a culturally sensitive and appropriate manner (focus groups will be conducted to inform the intervention), can improve breast, cervical and colon cancer screening rates compared to a control group. Furthermore, we plan to determine if pairing IVR with telephone calls from a prevention care coordinator (PCC) will result in higher screening rates (when compared to the IVR only group). We will determine the cost-effectiveness of IVR alone vs. IVR + PCC. Substudy: We conducted a substudy of the parent study, looking at a comparison of return rates of two colorectal cancer screening home test kits: Fecal Occult Bood Tests (gFOBTs) and Fecal Immunochemical Tests (FITs). As well we surveyed people who pick up one of these two types of tests to assess barriers and facilitators of returning the completed kit to the health center for assessment.

NCT ID: NCT01392066 Completed - Breast Cancer Clinical Trials

Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis

Start date: July 2011
Phase: N/A
Study type: Observational

The purpose of this study is to describe psychosocial adjustment in patients with breast cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study mutual influences of the partner on the patient and vice versa, and to identify risk and protective factors that influence the adjustment process in both patients and partners. The overall aim is to generate knowledge that helps enables us to integrate the partners' needs, problems and resources in treatment and rehabilitation of breast cancer patients.

NCT ID: NCT01391806 Completed - Breast Cancer Clinical Trials

The Impact of Preoperative Breast MRI in Patients With Breast Cancer Selected for Breast Conserving Surgery

Start date: January 2009
Phase: N/A
Study type: Observational

The purpose of this prospective observational study is to evaluate the impact of preoperative breast MRI in patients with breast cancer selected for breast- conserving surgery. MRI is a more sensitive radiological modality than mammography and ultrasonography. Patients with small breast cancers are, based on conventional modalities, selected for breast-conserving surgery. If preoperative breast MRI reveal additional lesions in the breasts, and malignancy is confirmed histopathologically, this finding leads to a change of surgical method to mastectomy.

NCT ID: NCT01390818 Completed - Breast Cancer Clinical Trials

Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors

Start date: May 2011
Phase: Phase 1
Study type: Interventional

This research trial is testing a combination of two experimental drugs, MSC1936369B (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR) inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary purpose of the study is to determine the maximum tolerated dose of the drug combination.