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Breast Neoplasms clinical trials

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NCT ID: NCT04699630 Recruiting - Clinical trials for Metastatic Breast Cancer

A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer

Start date: May 3, 2021
Phase: Phase 2
Study type: Interventional

This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).

NCT ID: NCT04698252 Recruiting - Breast Cancer Clinical Trials

Local Therapy for ER/PR-positive Oligometastatic Breast Cancer

LARA
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from ER/PR-positive breast cancer. The study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.

NCT ID: NCT04697043 Recruiting - Clinical trials for Breast Cancer Stage IV

The Benefit of Surgery in Stage IV of Breast Cancer

Start date: November 20, 2020
Phase: N/A
Study type: Interventional

Treatment of Metastatic Breast Cancer is not usually considered curative. Recent retrospective studies have demonstrated that resection of the breast tumor in patients with primary metastatic breast cancer is associated with a significant improvement of the prognosis. In all these aforementioned studies, the decision to perform surgery could have been influenced by favorable prognostic factors, such as younger age, the presence of only one metastatic site, or good response to systemic therapy. To rule out the impact of potential confounders, most studies adjusted for age, tumor size, number and sites of metastases and hormone receptor status. In addition, some studies also adjusted for comorbidity or surgical margins. For example, in the study of Bafford et al., the benefit of surgery seemed confined to patients operated upon before diagnosis of metastatic disease and there was no survival advantage in patients who received an operation of the breast tumor after the diagnosis of the metastatic disease had taken place. This phenomenon was referred to as the stage migration bias. In a study by Leung et al., the benefit from surgery disappeared in the multivariate analysis when taking into account the use of chemotherapy. Finally, in a study by Cady et al. coding errors in the retrospectively collected dataset were found to explain part of the survival advantage. 4Therefore, this randomized controlled trial (RCT) has been initiated. In the literature, several retrospective studies noted that 35-60% of patients with metastatic cancer at the time of diagnosis received local treatment of primary lesions, which resulted in a positive impact on survival. However, an analysis of 16,023 patients presenting with stage IV disease and an intact primary tumor compared outcomes between patients having surgery of the primary tumor to negative margins or no surgery. In a multivariate analysis adjusting for known prognostic factors, surgery reduced the HR for death to 0.61 (95% CI = 0.58 to 0.65). Multiple other retrospective studies from single institutions, registries, and population-based cohorts have confirmed this initial observation, but it is uncertain whether these studies reflect a real benefit for surgery or consistent selection bias. Three prospective randomized trials are examining the role of surgery in patients presenting with stage IV disease and an intact primary tumor. While awaiting the results of these trials, it is not known precisely how or when to integrate such surgical management into a standard medical therapy for metastatic breast cancer or which patients, in particular, are most likely to benefit from such treatment. 1 The aim of this study is to investigate the effect of surgery of the primary tumor in breast cancer patients with distant metastatic disease at initial diagnosis. According to the controversies in previous studies design of a study with the least confounding factor to decrease the bias seems to be necessary.

NCT ID: NCT04694885 Recruiting - Clinical trials for Breast Cancer Female

Quality of Life Improvement During Chemotherapy

QoLMa
Start date: July 31, 2021
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial, taking place at the University Hospital Basel (CH). It aims at the alleviation of breast cancer patients' life quality during chemotherapy. The intervention group will participate in 10 sessions of structured hypnotherapy during the course of chemotherapy in addition to the standard of care. The control group will have access to the standard of care without any additional treatment. The main goal of the study is to investigate whether quality of life is higher among patients in the intervention group. Additionally, it will be analyzed if the interventions have a positive effect on chemotherapy side effects, symptoms of anxiety and depression and the immune system. Finally, the relative dose intensity (RDI) as well as treatment schedule adherence will be assessed. There are no risks to be expected from the intervention itself. In the case of positive findings, the standard of psycho-oncological care can be updated by integrating structured hypnotherapeutic interventions into the treatment of patients with breast cancer.

NCT ID: NCT04692831 Recruiting - Clinical trials for HER2-positive Metastatic Breast Cancer

Testing a New Imaging Agent to Identify Cancer

Start date: November 30, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.

NCT ID: NCT04692818 Recruiting - Breast Tumor Clinical Trials

3D Ultrasound Breast Imaging

Start date: November 19, 2021
Phase: N/A
Study type: Interventional

The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.

NCT ID: NCT04690439 Recruiting - Breast Cancer Clinical Trials

Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

LymphLight
Start date: February 22, 2021
Phase: N/A
Study type: Interventional

Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.

NCT ID: NCT04687956 Recruiting - Breast Cancer Clinical Trials

Primary Surgical Prevention of Breast Cancer-related Lymphedema

LYMPHA
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.

NCT ID: NCT04685460 Recruiting - Breast Neoplasms Clinical Trials

3D Printed Bolus in Post-mastectomy Radiotherapy

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Recently, there is growing interest in the application of three-dimensional (3D) printed bolus to radiotherapy.At present, the researches on the application of 3D-printed bolus in breast cancer are mainly focused on air gap between skin and bolus or electron beam conformal therapy [7,15], there are no clinical experience with customized 3D-printed bolus for volumetric modulated arc therapy (VMAT) in daily practice has been published up to now. We aim to evaluate dosimetry and application of 3D-printed bolus for the post-mastectomy radiotherapy (PMRT) with Volumetric modulated arc therapy (VMAT). Seventy five patients with breast cancer receiving radiotherapy following post-mastectomy in our department were randomly selected in this study. The accuracy of fit of the 3D-Printed bolus to the chest wall was improved significantly relative to conventional bolus.This study demonstrates customized 3D-printed bolus in post-mastectomy radiation therapy improves fit of the bolus compared to conventional bolus. Furthermore, VMAT based on 3D-printed bolus significantly improves the chest wall target coverage and the conformity of plan, and reduces the dose of ipsilateral lung and heart, compared to conventional bolus.

NCT ID: NCT04683770 Recruiting - Breast Cancer Clinical Trials

Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer

Start date: July 1, 2020
Phase:
Study type: Observational

Our study is aimed to explore a prospective observational clinical study on the efficacy prediction and survival prediction of HR + / HER2 - biomarkers detection in patients with advanced breast cancer. This study is a prospective, observational clinical study. We analyzed the incidence of biomarker mutations in HR + / HER2 - advanced breast cancer (stage IV), and the correlation between biomarkers and therapeutic efficacy, survival, and prognosis.