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Breast Cancer clinical trials

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NCT ID: NCT04828044 Withdrawn - Breast Cancer Clinical Trials

Microwave Ablation of Breast Tumors

Start date: September 2012
Phase:
Study type: Observational

The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.

NCT ID: NCT04281355 Withdrawn - Breast Cancer Clinical Trials

Individualized Locoregional Treatment of Initially Biopsy-proven Node-positive Breast Cancer After Primary Systemic Therapy

INDAX
Start date: January 1, 2021
Phase: Phase 3
Study type: Interventional

In clinically node-positive (cN+) breast cancer, preoperative systemic therapy (PST) is common. With increasing rates of complete tumour eradication, there is a need for de-escalation of locoregional treatment in the interest of decreased morbidity. In order to individually adapt postoperative therapies, axillary staging is crucial. Axillary lymph node dissection (ALND) comes at a high risk of arm morbidity. There is extreme divergence in the use of less extensive staging methods, i.e. targeted lymph node biopsy (TLNB), sentinel node biopsy (SNB) or both (TAD), and in the use of subsequent locoregional treatment, since prospective data are largely lacking. The main purpose of the European INDAX trial is to implement de-escalated staging and evaluate which regional treatment, individually adapted to the response after PST, is oncologically safe but least harmful. Population: cN+ breast cancer patients receiving PST, recruited 2021-2025. Staging by TLNB, TAD or SNB. Intervention: Negative staging (ypN0, Randomisation A, N=1433): no regional treatment. Positive staging (ypN+, Randomisation B, N=1513): no ALND but regional radiotherapy (rRT). Control: Randomisation A: rRT only. Randomisation B: ALND plus rRT. Outcome: Invasive disease-free survival (non-inferiority), arm morbidity and quality of life. Drug tests in whole-tumour organoid cultures, algorithm-based digital image analysis and gene expression analysis are performed to improve response prediction, facilitate tailoring of PST and increase eradication rates.

NCT ID: NCT04232319 Withdrawn - Breast Cancer Clinical Trials

Feasibility and Effectiveness of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors

Start date: January 15, 2020
Phase: N/A
Study type: Interventional

The proposed research will assess the feasibility and preliminary effectiveness of a Sleep Hygiene Program for Breast Cancer Survivors. Participants will complete assessments related to sleep issues, participate in a Sleep Hygiene Program, and complete another assessment post-intervention.

NCT ID: NCT04220476 Withdrawn - Breast Cancer Clinical Trials

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

CIMER
Start date: March 4, 2020
Phase: Phase 2
Study type: Interventional

Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.

NCT ID: NCT04160182 Withdrawn - Breast Cancer Clinical Trials

Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors

Start date: January 27, 2020
Phase: N/A
Study type: Interventional

The purpose of this project is to determine the feasibility and effectiveness of a 6-week, internet-based, Energy Conservation and Activity Management intervention among women who report cancer-related fatigue following breast cancer treatment.

NCT ID: NCT04142554 Withdrawn - Breast Cancer Clinical Trials

Parsaclisib in Newly Diagnosed Stage I-IIIC Triple Negative or HER2+ Breast Cancer

LCCC1820
Start date: June 1, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to find the lowest dose of the cancer drug parsaclisib that has an effect on the type of breast cancer a participant has. Researchers are looking at how Parsaclisib affects the immune system. They want to learn whether and how it helps the immune system to find cancer cells to fight them. Parsaclisib is an oral drug that limits the effects of a protein called phosphatidylinositol 3-kinase δ (PI3K). By limiting P13K, parsaclisib can block certain cells that prevent the immune cells from working. As a result, it may help the body's immune system to fight tumors. Parsaclisib is being studied in several clinical trials to treat different types of cancers. Parsaclisib has not yet been approved by FDA for the treatment of cancer. Studies have shown that a good way to find out how cancer acts when exposed to anti-cancer drugs is through a pre-operative window study. In this type of study, tissue and blood are collected before treatment. Then subjects receive a study drug for a few weeks before surgery. Blood is drawn during the course of treatment, and leftover tissue is collected during surgery. Comparing the tissue and blood before and after treatment shows the effects the study drug may have had on the tumor. Research shows that cancers differ when you look at the DNA and RNA (genetic codes) that are inside a cancer cell. DNA and RNA carry genetic information that can determine traits in humans (such as eye color, height, reaction to treatment, etc.), as well as the traits of cancer cells. Depending on the genetic profile (particularly DNA and RNA) of the cancer, it may respond differently to parsaclisib. In this study, the investigators will look at the genetic profile of a participant's tumor by studying tissue and blood samples collected before and after receiving treatment.

NCT ID: NCT03918317 Withdrawn - Breast Cancer Clinical Trials

A Study of the Use of AirXpanders AeroForm in Patients Undergoing Post-Mastectomy Radiation Therapy

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

This study seeks to to determine the efficacy and side effect profile following radiation therapy for participants with the AeroForm device placed. The AeroForm device is FDA approved.

NCT ID: NCT03863301 Withdrawn - Breast Cancer Clinical Trials

MRI-guided Single Dose Preoperative Radiotherapy in Low-risk Breast Cancer

ABLATIVE-2
Start date: March 4, 2019
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect data on response monitoring. Patient-reported outcome measures and treatment-induced toxicity will be evaluated.

NCT ID: NCT03846583 Withdrawn - Breast Cancer Clinical Trials

Tucatinib + Abemaciclib + Herceptin for HER2+ MBC

Start date: June 28, 2020
Phase: Phase 1
Study type: Interventional

This research study is studying a combination of drugs as a possible treatment for HER2-Postive Metastatic Breast Cancer. The interventions involved in this study are: - Tucatinib - Abemaciclib (VerzenioTM) - Trastuzumab (Herceptin®) - Endocrine Therapy: Exemestane (Aromasin®), Letrozole (Femara®), or Anastrozole (Arimidex®)

NCT ID: NCT03794596 Withdrawn - Breast Cancer Clinical Trials

A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer

IMpALA
Start date: September 2019
Phase: Phase 2
Study type: Interventional

This research is being done because the investigators are looking for new and better ways to treat a type of breast cancer called triple negative breast cancer. This type of breast cancer can be more difficult to treat than other types of breast cancer as it does not respond to drugs such as hormonal therapies. One type of treatment that looks promising is immunotherapy using new drugs called immune checkpoint inhibitors. Immune checkpoints help to regulate the immune system and can stop the immune system from attacking cancer cells. Immune checkpoint inhibitors block this 'off-switch' and aim to help the immune system control the cancer. These drugs have been very effective in other cancers such as melanoma and are now being tested in breast cancer. In this study patients will receive an immune checkpoint inhibitor called avelumab. Half the patients on the study will also receive aspirin tablets for approximately 18 days as the investigators wish to compare the effects of avelumab alone versus in combination with aspirin. Patients will attend hospital approximately five times in order to complete all necessary study assessments. The first visit screens patients for suitability, after which a baseline visit will collect the first of two breast tissue biopsies. At the third visit a single dose of Avelumab will be given via an infusion (a drip in the forearm). Patients will then return approximately two weeks later for a second breast tissue biopsy before having a final follow up visit another two weeks later. Blood and urine samples will be taken at various visits throughout the study to help us learn more about the effects these treatments may have on the immune system and on breast cancer cells.