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Breast Cancer 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: NCT06139588 Completed - Breast Cancer Clinical Trials

Comparative Study of the Efficacy and Risk Profile of Two Animal-derived Acellular Dermal Matrices in Patients Undergoing Mastectomy, Radiotherapy and Implant-based Reconstruction

RTADM
Start date: June 1, 2017
Phase:
Study type: Observational

The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss) The main questions the study aims to answer are: - is one of the two matrices better than the other? (better results with fewer complications) - is there a group of patients who benefit more than another from the use of this type of devices? - is there an adm which works better in one specific subgroup of patients? Participants have undergone mastectomy, radiotherapy and implant reconstruction with the aid of two different kinds of acellular dermal matrices. Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications.

NCT ID: NCT06139107 Not yet recruiting - Breast Cancer Clinical Trials

RADIANT: Pre-op Radiation With Abemaciclib and Letrozole

Start date: December 21, 2023
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: NCT06137833 Not yet recruiting - Breast Cancer Clinical Trials

Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Adjuvant Chemotherapy

Start date: November 27, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effect of the administration of APPORTAL® in addition to the SoC (recommended physical exercise), in patients with breast cancer, suffering from fatigue during adjuvant chemotherapy. The main questions it aims to answer are: - if the food supplement APPORTAL® can be of help in supporting the physiological energy level, against the fatigue symptom in cancer patients undergoing adjuvant chemotherapy; - if the supplementation with APPORTAL® can optimize the nutritional status, the muscular strength, the quality of life of the patient. Also, the patients' satisfaction on the product received, the adherence to treatment will be evaluated and the overall safety and tolerability of the study product. The patients will be asked to perform 3 study visits from baseline to the end of treatment (at 4 and 8 weeks after baseline) and a follow-up visit after 12 weeks from baseline. The main assessments at each visit will be: - physical examination, weight, Body Mass Index (BMI), body temperature (°C), heart rate, respiratory frequency, and systolic and diastolic blood pressure; - previous and concomitant treatments; - fatigue assessment through BFI questionnaire; - quality of life through questionnaire SF-12; - muscular strength (dynamometer) - Adverse Event check (from Visit 2) Moreover, at visit 1 (baseline) and at visit 3 (end of treatment) a blood sample will be collected to evaluate the blood metabolites. Telephonic follow-up will be done at 2 weeks, 6 weeks, 10 weeks to assess compliance and to recommendations on physical activity and to study treatment (only at 2 and 6 weeks) and tolerability/safety. Participants will receive the nutrition supplement or the placebo, in addition to the SoC (recommended physical exercise), for 8 weeks. Researchers will compare Apportal® and Placebo groups to see if the physiological energy level against the fatigue symptom, the nutritional status, the muscular strength, the quality of life of the patient improve after 8 weeks of treatment with APPORTAL® in addition to SoC (recommended physical exercise).

NCT ID: NCT06137651 Not yet recruiting - Breast Carcinoma Clinical Trials

Trotabresib in Combination With Vinorelbine and Radiation Therapy for the Treatment of HER2+ Breast Cancer With Central Nervous System or Leptomeningeal Metastasis

Start date: December 31, 2023
Phase: Phase 1
Study type: Interventional

This phase I/Ib trial tests the safety, side effects, and best dose of vinorelbine when given in combination with trotabresib in treating patients with HER2 positive breast cancer that has spread to the central nervous system or leptomeninges (metastasis). Cancer cells that make too much HER2 may grow more quickly and are more likely to spread to other parts of the body as metastases, including the central nervous system. Trotabresib is part of a family of drugs called BET inhibitors. Trotabresib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vinorelbine is in a class of medications called vinca alkaloids. It works by slowing or stopping the growth of cancer cells in your body. Giving trotabresib and vinorelbine may increase in the anti-cancer activity of vinorelbine when used in combination with radiation (radiotherapy).

NCT ID: NCT06136923 Recruiting - Breast Cancer Clinical Trials

An Exploratory Study to Evaluate Attention Biases in Adults With Multiple Sclerosis, Breast Cancer, and Lung Cancer

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

CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo) components. DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self-processing) to optimally improve a participant's health.

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: NCT06134570 Enrolling by invitation - Breast Cancer Clinical Trials

ALDH1A1 Expression in Invasive Mammary Carcinoma

Start date: October 1, 2023
Phase:
Study type: Observational

ALDH1A1 isozyme oxidizes Retinaldehyde to retinoic acid, which regulates the expression of the genes involved in tumor-initiating stem-like cells, thereby initiating tumor growth and resistance to drugs. Much emphasis has been focused on ALDH1A1 as a CSC marker. High expression of ALDH1A1 has been reported as a poor prognostic marker in several tumor types and is associated with poor patient outcomes .

NCT ID: NCT06133959 Not yet recruiting - Breast Cancer Clinical Trials

Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer

HealthyME
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this two-phase project is to adapt The-Optimal-Lymph-Flow (TOLF) behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and Hispanic patients. The investigators have developed and tested behavioral intervention program TOLF that builds patients' self-management skills to promote lymph flow and results in complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, and improved quality of life (QOL). Of concern, this promising intervention has not been adapted to reduce patient barriers (e.g., relevance, cost, time, travel, competing demands) and system barriers (e.g., intervention availability, staffing, therapist) to timely interventions faced by Black and Hispanic women. Specific aims are to: Aim 1: Engage Black and Hispanic women (N=24) in adapting TOLF to be highly culturally appropriate. The investigators will conduct focus groups to refine TOLF focusing on barriers faced by and preferences of Black and Hispanic women. Aim 2: Conduct a pilot randomized controlled trial (RCT) (N=60) equally allocating women to either 1) TOLF or 2) lymphedema education (e-Lymph) to examine feasibility, acceptability, and examine primary outcomes (lymphatic pain, pain severity and interference, and lymph fluid level) and secondary outcomes (daily living function, psychological distress, QOL, self-efficacy for pain management) of the culturally appropriate behavioral interventions.