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Breast Neoplasms clinical trials

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NCT ID: NCT03761940 Recruiting - Radiotherapy Clinical Trials

Health Status of Women With Breast Cancer

OSTaRa
Start date: March 14, 2019
Phase:
Study type: Observational

The quality-adjusted life-year (QALY) is the outcome measure of choice in England and Wales for National Institute for Health and Care Excellence (NICE). To be able to conduct a cost utility analysis, QALY data is required. This can either be collected within trial or published data can be used. In the United Kingdom (UK) there is no up to date QALY data for women with early breast cancer treated with surgery followed by radiotherapy. The OSTaRa Study aims to provide up to date QALY data for women in this cohort.

NCT ID: NCT03761706 Recruiting - Breast Cancer Clinical Trials

Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging

Start date: February 28, 2018
Phase: N/A
Study type: Interventional

Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. Participants: 100 patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy. Procedures: The study entails screening, recruiting and consenting 100 eligible breast cancer patients who are about to begin adjuvant or neoadjuvant chemotherapy and agree to participate in a physical activity intervention, maintain a printed daily exercise log, wear a FitBit, complete questionnaires and assessments, and provide blood samples at various time points.

NCT ID: NCT03761420 Completed - Breast Neoplasm Clinical Trials

Adjuvant Endocrine Therapy in Early Stage Breast Cancer: Adherence and Clinical Outcome

Start date: August 1, 2019
Phase:
Study type: Observational

Breast cancer is the most common cancer among women in Norway. In 2016, 3402 new cases were diagnosed (3371 in women). Breast cancer is still the second most common cause of death from cancer among women with 585 breast cancer deaths in Norway in 2015. The majority of the patients (70-75 %) belong to the Luminal subtypes, which comprise the hormone receptor (oestrogen receptor (ER) and/or progesterone receptor (PR)) positive tumours. The most important systemic adjuvant therapy in luminal breast cancers is a long-lasting administration of per-oral anti-oestrogen medication. A systemic hypo estrogenic state in the body may be created by the selective oestrogen receptor modulator tamoxifen or by inhibitors of the peripheral systemic aromatization of adrenal androgens into estrogens (aromatase inhibitors). Initially, tamoxifen was given adjuvant for 2 years, later prolonged to 5 years and recently an extension to 10 years has been recommended for premenopausal women. Aromatase inhibitors were introduced in Norwegian treatment guidelines in 2002. Currently, they are recommended in postmenopausal patients for 5 years, either as monotherapy or in concert with tamoxifen (aromatase inhibitors for 2 years followed by tamoxifen for 3 years). In premenopausal breast cancer patients, tamoxifen still is the drug of choice. Two of the major underlying reasons for late recurrences in luminal breast cancer subtypes are development of endocrine resistance to tamoxifen and aromatase inhibitors or failure of taking the medication as prescribed. Higher mortality has been shown for breast cancer patients with reduced tamoxifen adherence. The patients' ability to follow instructions and recommendations are probably overestimated in controlled trials due to patient selection and close follow-up in the study setting. Some patients experience distressing side effects like hot flushes, fatigue, joint pain, mood swings and vaginal dryness. To the investigators' knowledge, there are few studies in Norway regarding discontinuation of endocrine treatment in breast cancer. In this study they will investigate the long-term discontinuation pattern to oral adjuvant systemic endocrine therapy in a large cohort of breast cancer patients treated in St. Olav's hospital in Trondheim, Norway, and the association between adherence to endocrine treatment and long-term survival.

NCT ID: NCT03760653 Withdrawn - Clinical trials for Breast Cancer Females

Synergic Effects of Physical Activity and Probiotic on Gut Immune System and Quality of Life of Breast Cancer Survivors.

ESICA
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Physical exercise along with gut microbiota improvement -because of probiotic intake- can improve the quality of life and immune system in breast cancer survivors. This is achieved because exercise improves the muscle mass in cancer patients (often reduced by treatment and/or inactivity), together with the gut microbiota improvement, this stimulates the inmune system function, improving the quality of life of these patients.

NCT ID: NCT03760588 Active, not recruiting - Heart Failure Clinical Trials

Prevention of Cardiac Dysfunction During Breast Cancer Therapy

PRADAII
Start date: January 14, 2019
Phase: Phase 2
Study type: Interventional

Breast cancer is the most common cancer among women. The modern post-surgery treatment with chemotherapy, immunotherapy, radiation and hormone therapy has improved the overall 5-years survival drastically. However, an unwanted effect of the post-surgery treatment is its potentially deleterious effect on the heart resulting in cardiac dysfunction. Angiotensin antagonists are used as part of the heart failure treatment. In smaller studies angiotensin antagonists have shown to have a cardioprotective effect during breast cancer treatment. Sacubitril/valsartan is a potent drug that in addition to an angiotensin antagonist contains a neprilysin inhibitor. Sacubitril/valsartan has proved to be superior to enalapril in chronic heart failure. In this randomized placebo controlled double blind trial we hypothesize that sacubitril/valsartan used concomitantly during anthracycline containing chemotherapy for breast cancer treatment prevents cardiac dysfunction as measured by cardiac magnetic resonance imaging (CMR). PRADA II is a Norwegian multicenter trial intending to recruit 214 patients and follow them for 18 months with CMR, cardiac ultrasound, blood samples, functional capacity tests and health related quality of life questionnaires.

NCT ID: NCT03759548 Recruiting - Breast Cancer Clinical Trials

Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer

Start date: November 1, 2018
Phase:
Study type: Observational

Cancer patients undergo many different modalities of treatments. Pharmacological treatment should be well understood. The nutritional status is not taken into account when calculating drug's doses and this may have an impact in toxicity and quality of life. The present study proposes to evaluate the relationship between the calculation of pharmacological treatment's doses, the toxicity and the impact on quality of life among colorectal and breast cancer's patients.

NCT ID: NCT03758976 Recruiting - Clinical trials for Metastatic Breast Cancer

Sweden Cancerome Analysis Network - Breast Recurrence (SCAN-B-rec)

Start date: January 21, 2019
Phase:
Study type: Observational [Patient Registry]

Prospective multicenter observational study to assess molecular drivers of metastatic breast cancer and disease evolution upon therapeutic pressure. The main aim is to develop and validate prognostic, predictive and pathogenic markers in clinically well-characterized population-based material of breast cancer tumors and the corresponding normal tissue.These data will be used to characterize recurrent breast cancer on a molecular level, study tumor evolution, develop biomarkers of response/resistance to targeted therapy in the metastatic setting, enroll patients on targeted treatment clinical studies and to elucidate mechanisms of resistance to therapy.

NCT ID: NCT03756298 Active, not recruiting - Clinical trials for Triple Negative Breast Cancer

Efficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy for Triple Receptor-Negative Breast Cancer

Start date: January 15, 2019
Phase: Phase 2
Study type: Interventional

This study will enroll patients who received neoadjuvant therapy for TNBC prior to surgery and did not get pCR. Given the relatively poor prognosis for these patients, this population is considered novel therapeutic as adjuvant treatment. Currently, capecitabine monotherapy could be beneficial to this group of patients according to CREATE-X trial results. The investigators are addressing the effect of anti-PD-L1, atezolizumab combined with capecitabine in patients with TNBC who did not get pCR after neoadjuvant chemotherapy compared to capecitabine monotherapy.

NCT ID: NCT03756090 Not yet recruiting - Breast Cancer Clinical Trials

The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer

PECP
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

This study will look at effects the combination of palbociclib and dose-dense neoadjuvant chemotherapy may have on triple negative breast cancer tumours which have not yet been treated.

NCT ID: NCT03756064 Recruiting - Breast Cancer Clinical Trials

Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.