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Breast Neoplasms clinical trials

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NCT ID: NCT06142344 Recruiting - Breast Cancer Clinical Trials

Radioembolisation and Chemotherapy in Liver Metastatic Breast Cancer Patients

HoLiBreast
Start date: October 19, 2023
Phase: N/A
Study type: Interventional

The goal of this multicentre clinical pilot study is to investigate the feasibility of the addition of Ho-166 radioembolization to chemotherapy in patients with liver metastastic breast cancer. Participants will receive a mapping angiography and Ho-166 radioembolization. Chemotherapy will be stopped 2-5 prior to radioembolization and continuation of chemotherapy will be evaluated at 2 weeks post-radioembolization.

NCT ID: NCT06139107 Recruiting - Breast Cancer Clinical Trials

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

Start date: June 21, 2024
Phase: Phase 1
Study type: Interventional

This phase 1b study investigates the safety and feasibility of combining pre-operative radiation therapy with Cyclin-Dependent Kinase 4 (CDK4/6) inhibitors in participants with hormone receptor positive/HER2 negative (HR+/HER2-) breast cancer. The study aims to assess the benefits of concurrent use of these treatments in a specific participant population, focusing on their safety and tolerability. The hypothesis is that the combination therapy will be well-tolerated, providing valuable insights into its effectiveness for future clinical applications.

NCT ID: NCT06135714 Recruiting - Breast Cancer Clinical Trials

Metastasis-directed Therapy for Oligometastases of Breast Cancer

OLIGAMI
Start date: November 8, 2023
Phase: Phase 3
Study type: Interventional

OLIGAMI trial is a multi-institutional, two-arm, open-label, randomized controlled phase III trial being conducted with the participation of 50 hospitals belonging to Japan Clinical Oncology Group. After the first registration, all patients will be performed in a 12-week, subtype-specific, systemic therapy consisting of CDK4/6 inhibitors with hormonal therapy for luminal BC, docetaxel with trastuzumab and pertuzumab for HER2-positive BC, chemotherapy with immune checkpoint inhibitors for triple-negativeBC expressing PD-L1, and olaparib for cases harboring BRCA mutations. For other triple-negative BC, chemotherapy will be administered. If this 12-week systemic therapy does not cause any progression or complete response, patients proceed to second registration for randomization; arm A continues same systemic therapy alone, and arm B performs MDT followed by same systemic therapy. The MDT will involve either RT or surgery, and RT will involve mainly SBRT and partly conventional RT.

NCT ID: NCT06135194 Recruiting - Breast Cancer Clinical Trials

Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib

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

To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib

NCT ID: NCT06133647 Recruiting - Clinical trials for Ductal Carcinoma in Situ

Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System

Start date: May 4, 2023
Phase:
Study type: Observational

To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).

NCT ID: NCT06133465 Recruiting - Clinical trials for Pleomorphic Lobular Breast Carcinoma in Situ

Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management

Start date: October 15, 2023
Phase:
Study type: Observational

The goal of this retrospective multicenter observational study is to understand and evaluate the diagnostic and therapeutic management of pure forms of Florid Lobular Carcinoma In Situ (FLCIS) and Pleomorphic Lobular Carcinoma In Situ (PLCIS) of the breast. It addresses the significant challenges and controversies surrounding their clinical management, due to a lack of consensus or approved international guidelines. The main questions this study aims to answer are: - How is the diagnostic process for pure FLCIS and PLCIS currently managed? - What are the primary therapeutic approaches for these specific breast conditions? - How are positive and "close" surgical excision margins handled? - Is adjuvant treatment, such as hormone therapy and radiotherapy, necessary? - What factors are associated with recurrences? - What are the rates of recurrences and/or upgrade to invasive carcinoma? Participants will retrospectively collect all cases of pure FLCIS and PLCIS, reporting detailed data about their diagnostic and therapeutic management, as well as clinical and survival outcomes. Methodology: This international multicenter retrospective study will collect cases involving the pure forms of FLCIS and PLCIS of the breast. The study aims to provide insights into the current diagnostic and therapeutic approaches, along with the identification of opportunities to enhance clinical management, ultimately providing evidence-based recommendations and addressing the current lack of scientific literature regarding their treatment.

NCT ID: NCT06133348 Recruiting - Breast Cancer Clinical Trials

Promoting Resilience in Women With Breast Cancer

PRISM
Start date: January 24, 2024
Phase: N/A
Study type: Interventional

The PRISM (Promoting Resilience in Stress Management) intervention is an evidence-based program that builds resilience. This program was developed in adolescent and young adult oncology and utilizes centrally administered skills-based coaching to bolster positive psychological tools known as resilience resources. These resources include stress management, goal-setting, and positive reframing. Previous studies using this intervention have found PRISM to be successfully administered remotely and it has improved resilience, psychological distress, hope, and quality of life. Among adult caregivers, PRISM has shown to improve resilience, self-efficacy, and engagement with medical care. While PRISM successfully targets distress and associated downstream consequences known to be experienced by breast cancer survivors, it has not been utilized in adults with cancer or in marginalized communities. Adapting this intervention to this context will require the testing of the intervention and, importantly, tailoring to meet the needs of women with breast cancer, particularly those of marginalized populations who may uniquely benefit from this intervention.

NCT ID: NCT06133088 Recruiting - Clinical trials for Advanced HR-positive and HER2-negative Breast Cancer; CDK4/6 Inhibitor Treatment Failed

Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial.

Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

This is a single-arm, Phase II clinical study to explore the efficacy and safety of dalpiciclib combined with fluvestrant and compound gossypol acetate tablets in advanced HR-positive and HER2-negative breast cancer after CDK4/6 treatment failed.

NCT ID: NCT06129786 Recruiting - Breast Cancer Clinical Trials

Overcoming Therapy Resistance in ER+ Breast Cancer Patients: a Translational Project (OVERTuRE)

OVERTuRE
Start date: May 18, 2023
Phase:
Study type: Observational

Patients presenting with a de novo diagnosis of luminal-like advanced breast cancer (ABC) or with disease recurrence after >12 months from the end of adjuvant ET, are generally candidate to a first line therapy with an aromatase inhibitor in association with a CDK4/6i. Disease recurrence in <12 months from the end of adjuvant ET defines the disease as "endocrine resistant" and identifies patients that should receive a first line therapy with the selective estrogen receptor degrader (SERD) Fulvestrant in association with the CDK4/6i Ribociclib, according to the results of the MONALEESA-3 trial. A significant percentage of ABC patients develops a primary resistance with disease progression within the first 6 months from the beginning of the treatment. Furthermore, another relevant percentage of patients initially responding to the therapy, will later develop a secondary resistance, thus progressing after a median of 2 years from the beginning of the treatment. Thereby, it is crucial to identify biomarkers that could be predictive of a response or a resistance to ET and/or CDK4/6i, to provide the best therapeutic strategy, tailored upon both clinico-pathological and molecular characteristics. Numerous pathways associated with resistance to CDK4/6i have been investigated by means of liquid biopsy analysis. The aim of this study is to identify potential biomarkers predictive of a clinical benefit in patients receiving a first line therapy with AI/fulvestrant (+/- LH-RH analogue) in association with a CDK4/6i for luminal-like advanced breast cancer.

NCT ID: NCT06129747 Recruiting - Breast Cancer Clinical Trials

Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast

Start date: November 30, 2023
Phase: Phase 2
Study type: Interventional

The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.