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Breast Neoplasms clinical trials

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NCT ID: NCT05064098 Recruiting - Breast Cancer Clinical Trials

Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients

Start date: June 29, 2021
Phase:
Study type: Observational

This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life.

NCT ID: NCT05063136 Recruiting - Breast Cancer Clinical Trials

Adjuvant Metronomic Capecitabine Plus Endocrine Therapy for HR+/HER2- Primary Breast Cancer

Start date: September 28, 2021
Phase: Phase 3
Study type: Interventional

Breast cancer (BC) is one of most prevalent malignant tumors in the world. According to the 2020 edition of the global cancer statistics report, the incidence rate of BC has overtaken lung cancer to become the most commonly diagnosed cancer. In the past three decades, survival of patients with primary BC have been notably improved, mainly due to early detection of the disease and advances in adjuvant treatments such as endocrine therapy, chemotherapy, and anti-HER2 therapy. Patients with HR-positive and HER2-negative primary BC account for approximately 70% of all cases of early breast cancer. Endocrine therapy is the core treatment for this subtype of BC. Tamoxifen, aromatase inhibitor or their sequential administration can reduce the recurrence and mortality of this BC subtype. The results of TEXT/SOFT study showed that, compared with the traditional 5-year tamoxifen treatment, tamoxifen + OFS or aromatase inhibitor + OFS can further improve the survival of HR+/HER2- breast cancer patients. However, for premenopausal BC patients with HR+/HER2-, only 82.5% (tamoxifen plus OFS) and 85.7% (aromatase inhibitor plus OFS) of 5-year DFS were achieved. For postmenopausal BC patients, the 5-year DFS was only about 84% with aromatase inhibitors. Therefore, the survival of HR+/ HER2- BC patients needs to be further improved. Metronomic chemotherapy refers to the use of the minimum effective dose of chemotherapy drugs for long-term, uninterrupted administration to achieve anti-tumor effect. Metronomic chemotherapy has gradually been verified in clinical practice in the past 20 years. In 2020, SYSUCC-001 study has confirmed that capecitabine (650 mg/ m2 bid, for 1 years) can reduce the risk of 5-year DFS events by 36% in TNBC patients in addition to standard treatment. Besides, POTENT study has confirmed that the combination of endocrine therapy and S-1 (for one year) can further reduce the risk of iDFS by 37% in HR+/HER2- BC patients who have completed the standard treatment. Compared with capecitabine, S-1 has no indication for BC and it is not in the recommendation for BC treatment in the guidelines. Therefore, the investigators conduct this study to explore whether adjuvant Capecitabine metronomic chemotherapy for one year can further improve the survival of BC patients with HR+/ HER2- in addition to standard treatment.

NCT ID: NCT05060068 Recruiting - Clinical trials for Breast Cancer Surgery

Effect of Intravenous S-ketamine on Opioid Consumption

Start date: October 7, 2021
Phase: N/A
Study type: Interventional

Female patients with an American Society of Anesthesia (ASA) physical status I-II, scheduled for elective breast cancer surgery will be included in the study. Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The primary outcome is the consumption of sufentanil during the surgery.

NCT ID: NCT05059444 Recruiting - Clinical trials for Non-small Cell Lung Cancer

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

ORACLE
Start date: September 7, 2021
Phase:
Study type: Observational

The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.

NCT ID: NCT05059379 Recruiting - Breast Cancer Clinical Trials

Medial vs. Entire Supraclavicular Lymph Node Radiation Therapy for Patients With Invasive Breast Cancer

SUCLANODE
Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

Locally advanced breast cancer has high-risk local regional recurrence after surgery. Radiotherapy could reduce the local regional recurrence and improve disease free survival and overall survival. Regional lymph node irradiation is the important part of breast cancer radiotherapy. However, there are some controversies about regional lymph node delineation, especially the supraclavicular irradiation volume. Many studies had confirmed that posterolateral region of the supraclavicular fossa (also named Posterior neck lymph node) had a high risk involvement based on the mapping of recurrence nodes. This randomized phase III trial compares medial supraclavicular lymph node irradiation with entire supraclavicular lymph node irradiation in patients with pathologically positive axillary lymph node and high risk of recurrence after mastectomy or breast conservative surgery. It is not yet known if radiation works better with entire supraclavicular fossa than medial supraclavicular fossa.

NCT ID: NCT05058183 Recruiting - Breast Cancer Clinical Trials

Safe De-escalation of Chemotherapy for Stage 1 Breast Cancer

Safe-De
Start date: June 5, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to assess the rates of circulating tumour DNA (ctDNA) in patients treated with surgery for stage 1 breast cancer that is HER2 positive or triple negative. The study will involve collecting blood samples from patients before and after surgery, if patients are enrolled after surgery, blood samples will be collected after the procedure. On the follow-up visit, the results obtained from the blood tests will serve as a diagnostic method to discern adverse outcomes in the groups of patients with positive and negative ctDNA detection. Also, the results obtained will aid physicians in determining treatment courses for patients, in order to reduce the intensity of adjuvant chemotherapy. By identifying the patients with residual disease with ctDNA analysis, it is possible that this will improve disease prognosis.

NCT ID: NCT05057598 Recruiting - Breast Cancer Clinical Trials

DianaWeb: Before and After Study Online Based Participatory Research on Breast Cancer Women

DianaWeb
Start date: June 21, 2016
Phase: N/A
Study type: Interventional

DianaWeb is a community-based participatory research (CBPR) offered to Italian breast cancer patients. The aim of the study is the evaluation of effectiveness of a lifestyle and nutrition intervention to improve the prognosis. DianaWeb study utilizes an interactive website - http://www.dianaweb.org/ - to monitor patient life-style, and to obtain clinical, pathological and anthropometric data (height, body weight, waist circumference and blood pressure). Detailed instructions were provided for measuring at home. The website contains theoretical and practical advice to encourage women to follow healthy lifestyles and nutrition, and the indications emerging from research for women diagnosed with breast cancer. DianaWeb study intends to recruit 50.000 women with breast cancer diagnosis.

NCT ID: NCT05056857 Recruiting - Breast Carcinoma Clinical Trials

Neutrophil Extracellular Traps Formation in Breast Cancer Patients Taking Tamoxifen

Start date: October 1, 2021
Phase:
Study type: Observational

This study examines the long-term effects of tamoxifen (TAM) treatment on excessive production of neutrophil extracellular traps (NET) and their impact on breast cancer and side effects. NET are produced by the body to fight infections but have also been linked to side effects caused by the body's immune system. Treatment with tamoxifen increases the production of NETs. This study may help researchers determine if the increased number of NETs in the body has a damaging effect in breast cancer.

NCT ID: NCT05056844 Recruiting - Breast Carcinoma Clinical Trials

Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

This clinical trial studies contrast enhanced spectral mammography (CESM) for the evaluation of pathologic nipple discharge. CESM is similar to standard mammography, but it includes an intravenous (by vein) injection of an iodine-based contrast, which makes tissue and blood vessels more visible in scans. The goal of this trial is to learn if CESM, is better than standard mammography in quickly and efficiently determining the cause of nipple discharge and detecting breast cancer, if present. CESM may increase the chance of finding breast cancers and lower the risk of having unnecessary biopsies.

NCT ID: NCT05056818 Recruiting - Breast Carcinoma Clinical Trials

Comparison of Synthetic Mammography Versus Full-Field Digital Mammography in Image Interpretation and Performance Metrics

Start date: December 15, 2020
Phase:
Study type: Observational

This study compares synthetic mammography to full-field digital mammography in image interpretation and performance metrics. Digital breast tomosynthesis (DBT) has previously been found to be superior in performance to standard digital mammography in both screening and diagnostic settings for the early detection and improved diagnosis of breast cancers. DBT in combination with full-field digital mammography (FFDM) reduces recall rates and increases cancer detection rates relative to FFDM alone. Synthetic mammography is a 2-dimensional reconstructed image, using the dataset derived from the DBT acquisition, without requiring additional radiation dose. Collecting information from patients' medical records may help doctors analyze the characteristics, utility, and impact of synthetic mammography to compared to FFDM.