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Breast Neoplasms clinical trials

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NCT ID: NCT03471663 Completed - Breast Cancer Clinical Trials

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

Start date: March 18, 2018
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.

NCT ID: NCT03471494 Completed - Gastric Cancer Clinical Trials

GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery

GS3
Start date: April 1, 2018
Phase:
Study type: Observational

Aim The aim is to determine the variation in quality of cancer surgery worldwide. Quality will be determined using measures covering infrastructure, care processes, and outcomes. The study will concentrate on the most common surgically treated cancers worldwide: breast, gastric and colorectal cancer. The primary aim focusses on 30-day mortality and complication rates after cancer surgery. The secondary aim is to characterise infrastructure and care processes in the treatment of these cancers worldwide. Primary outcome measure 30-day mortality and complication rates after cancer surgery. Primary comparison Between country groups defined by human development index. Hospital eligibility Any hospital in the world performing surgery for breast, gastric or colorectal cancer. Patient eligibility Consecutive patients undergoing surgery for breast, gastric, or colorectal cancer. Surgery can be with palliative or curative intent. Team Individual hospital teams with up to three people, collecting data for four weeks. Several teams collecting data over multiple four-week periods is encouraged. Time period Patients will be identified, and data collected on all patients during the time-period with follow-up to 30-days. The study will run from 1st April 2018 to 31st October 2018 (with follow-up of the last period to 30th November 2018). Validation Data validation will be in two parts. First, centres will self-report the key processes used to identify and follow-up patients. Second, independent validators will quantitatively report case ascertainment and sampled data accuracy.

NCT ID: NCT03470935 Completed - Clinical trials for Breast Cancer Female

Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger

ARTEMIS
Start date: September 15, 2017
Phase:
Study type: Observational

Brest cancer is the most common cancer in women in France with 52.000 new cases diagnosed in 2010 including nearly 6.000 women younger than 40. The improvement of the fertility conservation of cancer patients is one of the goals put forward by the french Cancer Plan (Objective 8.1). The issue of fertility after a breast cancer is a frequently raised subjects by the concerned couples today. The improvement in prognosis due to therapeutic advances combined with the increasing age of the first pregnancy and in the recomposed couples bring number of young women between 35 and 40 years followed for breast cancer today to raise these questions with their oncologists. Young women have a greater risk to develop agressive tumors requiring a mulitimodal treatment whose general and gonadic side effects can be important and permanently impact the reproductive capacity. At the time of diagnosis, almost 50% of these young patients report that they want to consider a later pregnancy but no data are available on the evolution of this wish over time although it is known that anti-cancer treatments have a serious impact on future possibilities of pregnancy(s). The sequential chemotherapy regimen prescribed in adjuvant or neo-adjuvant situation includes intercaling agents (antracyclines) and an alkylating agent (cyclophosphamide) partially responsible for subsequent fertility disorders. In addition, a chemotherapy-induced amenorrhea (CAI) occurs in 50 to 80% of women according to the studies, the latter is sometines definitive and sequellar of treatment. However, few data describe the time of recovery of menstrual cycles in women with CAI and subsequent impact of fertility. The aim of this study is to evaluate the impact of cancer diagnosis and treatment on the wishes of fertility before and after the management of cancer of the patients in question, on the recovery of menstrual cycles and the quality of sexual life of these patients. The investigators hope to improve the pre-therapeutic evaluation of women wishing to implement measures to preserve fertility, to assist women wishing to consider this type of project after cytotoxic treatments and accompany women suffering from a change in self-image that has an impact on their quality of life. These results could help to sensitize the doctors to the difficulties encountered by young women and to improve and/or to strengthen the global and adapted care of these patients.

NCT ID: NCT03468881 Recruiting - Breast Cancer Clinical Trials

A Communication Skills Package to Prevent Fear of Cancer Recurrence

FORECAST2
Start date: September 1, 2018
Phase:
Study type: Observational

This study (FORECAST 2) builds upon the work of the successful pilot study (FORECAST) that found some evidence that breast cancer patients' fears of cancer recurrence (FCR) were sensitive to the communication exchange with therapeutic radiographers during weekly review appointments. The aim of FORECAST 2 is to co-design and pilot a communication training package for therapeutic radiographers to help them manage emotional talk with breast cancer patients who are undergoing treatment, with the intention to minimise patients' development of FCR during this trajectory.

NCT ID: NCT03468374 Not yet recruiting - Clinical trials for Early-stage Breast Cancer

Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT

Start date: July 2018
Phase: N/A
Study type: Interventional

Role of SPECT/CT in detection of sentinel lymph node in patients with breast cancer that is in early stage with small mass with no nodal or distant metastasis using radioactive material nannocolloid that can change surgical approach

NCT ID: NCT03465813 Completed - Breast Cancer Clinical Trials

Reducing Distress and Depressive-symptoms in Rural Women

Start date: July 19, 2017
Phase: N/A
Study type: Interventional

Approximately 30% of U.S. breast cancer survivors experience significant cancer-related distress ranging from adjustment disorders, depression-symptoms and major depression up to 20 years after diagnosis. For rural cancer survivors, lack of access to care, support and stigma associated with cancer and mental health, challenge rural women's ability to prevent cancer-related distress and its deleterious outcomes. However, these barriers may be overcome by a new Internet-based psychoeducational program designed for newly diagnosed women; CaringGuidanceâ„¢- After Breast Cancer Diagnosis. This self-guided program provides information, cognitive-behavioral and supportive coping strategies in a text/audio/visual format accessed via Internet/mobile devices to increase understanding and provide supportive tools to prevent/manage distress and depressive-symptoms. This pilot study will determine preliminary efficacy of the CaringGuidanceâ„¢ program on distress and depressive-symptoms monthly and over 3 months, for rural women newly diagnosed with breast cancer.

NCT ID: NCT03464942 Completed - Breast Cancer Clinical Trials

Stereotactic Radiation and Immunotherapy in Patients With Advanced Triple Negative Breast Cancer

AZTEC
Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

This is a multi-centre, open label, phase 2, randomised controlled trial of patients with advanced triple negative breast cancer (TNBC) who have received no more than one line of chemotherapy (not including neoadjuvant or adjuvant therapy) who will be randomised to be treated with SABR 20Gy in 1# followed by atezolizumab or SABR 24Gy in 3# followed by atezolizumab.

NCT ID: NCT03463954 Recruiting - Clinical trials for Malignant Neoplasm of Breast

Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors

Start date: August 9, 2023
Phase: N/A
Study type: Interventional

Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.

NCT ID: NCT03462251 Completed - Breast Cancer Clinical Trials

Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line

RIBBIT
Start date: May 24, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib in combination with aromatase inhibitor (AI) or fulvestrant OR capecitabine with bevacizumab OR paclitaxel with / without bevacizumab in patients with HR-positive, HER2-negative advanced breast cancer with visceral metastasis. Half of the patients will receive a combination of ribociclib and AI/fulvestrant while the other half will receive capecitabine + bevacizumab or paclitaxel +/- bevacizumab.

NCT ID: NCT03461588 Completed - Breast Neoplasms Clinical Trials

Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

This study is to prospectively investigate the cardiac dose-sparing effect and clinical benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast cancer treated with breast conserving surgery followed by radiotherapy is enrolled. Radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters and cardiac toxicity are prospective evaluated, and the dose-effect relationship is analyzed.