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Breast Neoplasms clinical trials

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NCT ID: NCT04103853 Completed - Clinical trials for Metastatic Breast Cancer

Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer

Start date: September 6, 2017
Phase: Phase 1
Study type: Interventional

This study is a multi-center, open-label, dose-esclation I/Ib clinical study to explore safety, efficacy an pharmacokinetics of proxalutamide in patients with metastatic breast cancer. This study includes two stages, stage I: single- and multiple-dose tolerance and pharmacokinetic study; stage 2: preliminary efficacy and safety study.

NCT ID: NCT04098926 Completed - Breast Cancer Clinical Trials

Highly Accelerated Dose-Integrated Radiotherapy in 5 Fractions in Breast Cancer

HAI-5
Start date: January 2015
Phase: N/A
Study type: Interventional

Adjuvant radiotherapy in breast cancer improves local control, also in the elderly. Hormonal therapy in hormone sensitive tumors improves results but can not substitute radiotherapy. Improved local control leads to less breast cancer related morbidity and mortality, also in an older population (Schonberg, JCO, 2011). Unfortunately, in older patients with lower life expectancy, adjuvant radiotherapy is often omitted. Following reasons are invoked: - frailty of the patient - fear for toxicity - impaired mobility, rendering transportation and positioning more difficult - dependency for transportation to and from the radiotherapy departement - negative cost effectiveness ratio, due to high cost (especially for complex techniques and long schedules) and lower benefit (lower life expectancy) Hypofractionation is feasible without increased toxicity, and combines better local control with patient comfort and lower costs. Further lowering the number of fractions (from 15-21 to 5) will further improve patient comfort, but is challenging when different doses are needed in the same target volume. This problem is addressed using advanced techniques permitting dose-integration. In the elder with cancer, several unrecognized geriatric problems, including depression and cognitive impairment, can be detected by CGA . Some problems do interact with cancer treatment. In this study screening and assessment is provided to support patients and to develop an inventory of radiotherapy obstacles. Our study includes breast cancer patients, ≥70 years old, referred for adjuvant radiotherapy after surgical treatment. A schedule of 5 fractions is offered, encompassing different targets of treatment.

NCT ID: NCT04098783 Completed - Breast Cancer Clinical Trials

Health Belief Model Based Nursing Interventions on Lymphedema Prevention

Start date: May 15, 2016
Phase: N/A
Study type: Interventional

Aim: The study was performed to examine effects of Health Belief Model based nursing interventions given at home visits on prevention of lymphedema in women having breast surgery. Methods: The study had an experimental design. 72 women receiving radiotherapy after breast surgery, of whom 37 formed the intervention group and 35 formed the control group. The study had an experimental design. Data were collected with a personal information questionnaire, Quick-Disabilities of the Arm, Shoulder and Hand Score (Q-DASH), European Organization for Research and Treatment of Cancer Quality of Life for Breast Cancer 23 (EORTC QLQ-BR23), Strategies Used by Patients to Promote Health (SUPPH), Arm Circumference Form at three home visits at three-month intervals. Hypotheses of the study 1. Extremity function restrictions will be lower in the intervention group than in the control group. 2. Self-efficacy levels will be higher in the intervention group than in the control group. 3. Functions improving the quality of life will be higher in the intervention group than in the control group. 4. There will be fewer symptoms reducing the quality of life in the intervention group than in the control group. 5. The incidence of lymphedema will be lower in the intervention group than in the control group. 6. The mean cost of the intervention group at home visits, will be lower than in the control group. What does this paper contribute? - Nurses can play an effective role in enabling women undergoing breast surgery to acquire behavior of lymphedema prevention. This may reduce treatment costs. - Future research should evaluate collaborative models of care in general practice aimed at improving lymphedema prevention for women undergoing breast surgery. - Policymakers should consider introducing funding measures for breast cancer survivors by nurses.

NCT ID: NCT04097756 Completed - Clinical trials for Advanced Breast Cancer

A Phase I Study of LX-039 Tablets

Start date: January 7, 2020
Phase: Phase 1
Study type: Interventional

This is a phase I dose escalation and expansion study in patients with ER+, HER2- advanced breast cancer to explore the tolerance, PK/PD(pharmacokinetics/pharmacodynamics) profiles and preliminary anti-tumor activity of different doses of LX-039 tablets. The trial consists of two parts, dose escalation and dose expansion. Part 1 is the dose escalation phase with initial 6 dose groups, and "3 + 3" design is used to explore MTD of the drug; Part 2 is the dose expansion phase with 2 ~ 3 doses selected for expansion according to the escalation results of Part 1, and more subjects are enrolled to further observe the tolerance and preliminary anti-tumor activity of the drug. After the completion of dose expansion, the recommended phase II dose (RP2D) will be determined after discussion based on the obtained tolerance and PK/PD data.

NCT ID: NCT04091542 Completed - Breast Cancer Clinical Trials

Hyperventilation and Oxygenation to Prolong Breath Hold in Breast Cancer Irradiation Treatment

HOBBIT
Start date: March 15, 2019
Phase: N/A
Study type: Interventional

With the HOBBIT trial, the investigators want to develop a technology that allows volunteers to hold their breath for a long time. This technique will then be taught to patients with breast cancer to be able to hold their breath long-term during the irradiation. After all, research has shown that the heart is in a better position when the patient enters her breath after a deep inhalation, as a result of which there is less unwanted radiation of the heart. To develop this technique the investigators use healthy volunteers, who are asked several times to hold their breath as long as comfortable. Before the respiratory arrest the investigators allow these volunteers to hyperventilate, administer oxygen and cause hyperinflation of the lungs. The volunteers come back four times, on four consecutive days. The first day they receive a short training. Afterwards oxygen is administered for a few minutes while the volunteers are asked to hyperventilate. Afterwards, by using the learned technique, they must hold their breath for as long as possible, comfortably. They should hold their breath 3 times in total with a short break in between. The following days there is always a change in the preparation protocol, compared to the previous study. Different parameters in the protocol will be changed for different groups of volunteers, this is based on randomization. In this way the effect of different parameters in the preparation of the AHS can be investigated. The investigators will use this information to develop a new protocol for extending the duration of breathing to two minutes and thirty seconds for use during radiotherapy treatment. The method for finding the optimal technique is iterative optimization. This method follows a process of development, testing, feedback and redevelopment cycles. Iteratively, these cycles of development use the prior research to further elaborate the most promising discoveries and drop paths that do not produce the desired result. During the development The investigators listen to the input of different people: doctors, nurses, support staff, engineers and the participants, to guarantee the usability of the technique on the radiotherapy device. Once the researchers think they have found a solution that meets all the conditions, a group of untrained volunteers are asked to implement the technique. With this the investigators validate the technique for later use in breast cancer patients.

NCT ID: NCT04091178 Completed - Breast Cancer Clinical Trials

Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer

OPTIVIT
Start date: October 10, 2013
Phase: Phase 2
Study type: Interventional

An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy. A calcium supplementation will be prescribed in parallel. An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy

NCT ID: NCT04090164 Completed - Breast Cancer Clinical Trials

Association of Hepatitis C Virus With Breast Cancer

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

Hepatitis C viral infection is a major health problem in Egypt. The management of breast cancer patients is often complicated by the presence of associated HCV infection. This study aims at investigating the epidemiological association of the two conditions. It will also investigate the possible correlation with treatment outcome.

NCT ID: NCT04088877 Completed - Breast Cancer Clinical Trials

Rise Up After Breast Cancer

RISE-UP
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The objectives of this pilot study are to determine the feasibility of a community-based moderate intensity resistance exercise training (RET) program in combination with an art sculpting class on body image in breast cancer survivors (BCS). The protocol will be measuring recruitment; attendance; cost tracking; body image distress; body image appreciation; and muscular strength. Participant feedback on the intervention will be collected through a final focus group. Additionally, cognitive interviews will occur prior to the intervention, where participants will be asked to "think-out-loud" as they answer the Body Image Scale for Cancer questionnaire. The purpose of this interview technique is to gain a deeper understanding of the participants' thought process behind choosing each answer. The proposed pilot study will be a single prospective before and after study that will help inform a future large-scale project. A minimum sample of 12 subjects will be recruited. The Health Research Ethics Board of Alberta Cancer Committee will approve this study. Participants will participate in RET biweekly for 12 weeks and the sculpting class weekly for 8 weeks. After the first week of RET, the art class will begin. Both the RET and sculpting class will be between 1-2 hours in length. Analyses: Quality of life, fitness testing and body image scales will be administered before and after the intervention. Cognitive interviews will occur once before the intervention has started and a final focus group will occur at the end of the intervention to get participant feedback on the effectiveness of the program

NCT ID: NCT04087057 Completed - Clinical trials for Invasive Breast Carcinoma

Barriers Associated With Timely Adjuvant Chemotherapy Administration in Patients With Invasive Breast Cancer

Start date: August 23, 2019
Phase:
Study type: Observational

This trial studies the barriers associated with timely chemotherapy given after surgery (adjuvant) in patients with invasive breast cancer. Meeting with patients and asking questions may help doctors to learn about factors that can cause delays in the start of chemotherapy after surgery in patients with breast cancer.

NCT ID: NCT04081389 Completed - Clinical trials for Anatomic Stage II Breast Cancer AJCC v8

Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer

Start date: December 6, 2019
Phase: Phase 1
Study type: Interventional

This phase I trial studies how well chemokine modulation therapy and standard chemotherapy given before surgery work in treating patients with early stage triple negative breast cancer. Chemokine modulation therapy, including celecoxib, recombinant interferon alfa-2b, and rintatolimod, may stimulate the immune system and stop tumor cells from growing. Drugs used in standard chemotherapy, such as paclitaxel, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemokine modulation therapy together with standard chemotherapy may work better than giving either therapy alone in treating patients with triple negative breast cancer.