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Breast Neoplasms clinical trials

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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: NCT01402193 Recruiting - Breast Cancer Clinical Trials

Study of Arimidex and Radiotherapy Sequencing

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

The purpose of this study is to compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.

NCT ID: NCT01401166 Active, not recruiting - Breast Cancer Clinical Trials

Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in HER2-positive Early Breast Cancer

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This randomized, open-label, crossover study evaluated participants' preference and healthcare professional satisfaction with trastuzumab (Herceptin) subcutaneous (sc) versus intravenous (iv) administration in participants with HER2-positive early breast cancer.

NCT ID: NCT01401062 Completed - Clinical trials for Metastatic Breast Cancer

Fresolimumab and Radiotherapy in Metastatic Breast Cancer

Start date: July 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test safety of combining fresolimumab and local radiotherapy and to see if the combination can achieve tumor regression.

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: NCT01400399 Recruiting - Breast Carcinoma Clinical Trials

Cosmetic Evaluation of Lumpectomy Versus Oncolytic Mammoplasty With Bilateral Breast Reduction for Early Stage Breast Cancer

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

This study will evaluate the cosmetic outcome and examine factors contributing to cosmetic outcome in women treated with lumpectomy or bilateral breast reduction mammoplasty/mastopexy (BRM) followed by hypofractionated whole breast irradiation. Breast conservation is now an established method of treatment for early breast cancer. Because breast conservation is essentially a cosmetic alternative to mastectomy, quality of life, cosmetic outcome and tumor control are all important considerations during comprehensive treatment planning. Irradiation schemes have been demonstrated to be efficacious and with excellent short term cosmetic outcomes. However, their interaction with currently evolving surgical techniques needs to be examined in order to maintain optimal local control while preserving cosmetic outcome.

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.