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Breast Neoplasms clinical trials

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NCT ID: NCT05865990 Recruiting - Clinical trials for Metastatic Breast Cancer

HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease

TUXEDO-3
Start date: November 24, 2023
Phase: Phase 2
Study type: Interventional

The goal of this phase II clinical trial] is to analyze the efficacy of patritumab deruxtecan (HER3-DXd) in patients with metastatic breast cancer (MBC) or advanced non-small cell lung cancer (aNSCLC) with active brain metastases (BM) who have received at least one line of systemic therapy in the advanced setting, or patients with active leptomeningeal carcinomatosis/disease (LMD) after radiotherapy from an advanced solid tumor who do not need immediate local treatment, and have not received prior treatment with an anti-HER3 targeted drug]. The main questions it aims to answer are: - The intracranial objective response rate (ORR-IC) per local investigator as judged by best central nervous system (CNS) response according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria of HER3-DXd in patients with active BM from MBC (Cohort 1) and aNSCLC (Cohort 2). - The overall survival (OS) rate at 3 months of HER3-DXd in patients with advanced solid tumors with untreated LMD (Cohort 3). Participants will receive HER3-DXd on day (D1) of each 21-day cycle until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Researchers will compare historical groups to see if HER3-DXd positively impacts patient outcomes.

NCT ID: NCT05862064 Recruiting - Clinical trials for TNBC - Triple-Negative Breast Cancer

PD-1 Combined With Adjuvant Chemotherapy and Antivascular Therapy Versus Chemotherapy Alone in Patients With Operable Triple-negative Breast Cancer

Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

This review will evaluate the efficacy, safety, and pharmacokinetics of SHR1210 (carrelizumab) compared with the antivascular drug famitinib in combination with anthracyclines/taxane-based adjuvant chemotherapy (carrelizumab + FAM + EC-P) compared with conventional chemotherapy regimens (dose-intensive epirubicin and cyclophosphamide, sequential paclitaxel, or EC-P) in patients with early-stage high-risk TNBC.

NCT ID: NCT05861830 Recruiting - Clinical trials for Advanced Breast Cancer

Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)

Start date: May 15, 2023
Phase: Phase 3
Study type: Interventional

CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors. The MAINTAIN study has shown clinical benefits by switching to Ribociclib and changing endocrine therapy after progression on CDK4/6 inhibitors. We hypothesize that combining Dalpiciclib with physician-selected endocrine therapy, following treatment failure with CDK4/6 inhibitors, would similarly lead to improved patient survival. In this study, 18F-FES PET/CT will be employed as a non-invasive alternative to biopsy techniques for evaluating the expression of ER in various systemic lesions of the patients.

NCT ID: NCT05861635 Recruiting - Breast Cancer Clinical Trials

The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression

Start date: February 1, 2023
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy and safety of vidicizumab combined with tirelizumab in the treatment of early high-risk or locally advanced breast cancer with low HER2 expression

NCT ID: NCT05861271 Recruiting - Clinical trials for Breast Cancer Stage I

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

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

For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with tumors larger than 1 cm or lymph node-positive. The APT study enrolled patients with stage I HER2-positive breast cancer and has confirmed the efficacy and safety of intravenous chemotherapy combined with targeted therapy, but only 2.2% of the patients enrolled in microinvasion are enrolled, and there is a lack of large sample size data to provide a treatment reference for these patients. In order to further explore the optimal strategy for adjuvant therapy in this type of patient, we designed a new clinical trial to evaluate the efficacy and safety of oral capecitabine plus pyrotinib as adjuvant therapy in previous retrospective studies.

NCT ID: NCT05860621 Recruiting - Clinical trials for Breast Cancer Female

Promoting Physical Activity in Breast Cancer Survivors on Aromatase Inhibitors

PAC-WOMAN
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

Aromatase inhibitors (AI) are frequently used to treat hormone-receptor-positive breast cancer, but they have multiple adverse effects (eg, arthralgia), resulting in premature therapy discontinuation/switch. Physical activity (PA) can attenuate these negative effects and improve quality of life (QoL). However, most cancer survivors fail to perform/sustain adequate PA levels, especially in the long-term. Theory-based interventions, using evidence-based behavior change techniques, aimed at promoting long-term behavior change in breast cancer survivors are effective, but remain scarce and fail to promote self-regulatory skills and better-quality motivations associated with sustained PA adoption. PAC-WOMAN will test the long-term effectiveness and cost-effectiveness of two state of the art, group-based interventions encouraging sustained changes in PA, sedentary behavior, and QoL. Additional aims include examining the impact of both interventions on secondary outcomes (eg, body composition, physical function), and key moderators/mediators of short and long-term changes in primary outcomes. A 3-arm pragmatic randomized controlled trial, involving a 4-month intervention and a 12-month follow-up, will be implemented, in a real exercise setting, to compare: 1) brief PA counseling/motivational intervention; 2) structured exercise program vs. waiting-list control group. Study recruitment goal is 122 hormone-receptor-positive breast cancer survivors (stage I-III), on AI therapy (post-primary treatment completion) ≥1 month, performance status 0-1. Outcome measures will be obtained at baseline, 4 months (i.e., post-intervention), 10 and 16 months. Process evaluation, analyzing implementation determinants, will also be conducted. PAC-WOMAN is expected to have a relevant impact on participants PA and QoL, and on the improvement of interventions designed to promote sustained adherence to active lifestyle behaviors, facilitating its translation to community settings.

NCT ID: NCT05860465 Recruiting - Clinical trials for Locally Advanced or Metastatic Breast Cancer

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

Start date: September 8, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.

NCT ID: NCT05858762 Recruiting - Clinical trials for Breast Cancer Diagnosis

Artificial Intelligence for Automated Diagnosis of Breast Cancer

AICAMAMMELLA
Start date: October 20, 2020
Phase:
Study type: Observational [Patient Registry]

Mammography is a two-dimensional imaging technique which involves the tissues overlapping under the projective image; dense glandular tissue above or below the lesion can reduce the visibility of the lesion. The trouble could be the interpretation of the image obtained which may lead to the inability to visualize a fist stage cancer and the probability that to a healthy person will be diagnosed a pathology that is not present (false positive). The introduction of an almost three-dimensional technique imaging called breast digital tomosynthesis (DBT) can overcome most limitations. In the last 5 years image analysis methods based on Artificial Intelligence (, AI) have also been massively introduced in breast cancer detection. The study is a prospective observational study based on Artificial intelligence whose the mail goal is to develop a method to identify a lesion.

NCT ID: NCT05858242 Recruiting - Breast Cancer Clinical Trials

Study on Early Auxiliary Diagnosis and Postoperative Recurrence Monitoring of Breast Cancer

Start date: March 7, 2023
Phase:
Study type: Observational

This study screened and identified effective methylation markers in breast cancer, established a detection system for early screening and early diagnosis, and provided a research basis for the embryonic form of non-invasive breast cancer early screening products in later incubation. Then, the plasma ctDNA polygene methylation test was performed for early and middle stage breast cancer patients who were to receive radical surgery for initial treatment, and the predictive effect of postoperative plasma ctDNA methylation status on postoperative prognosis of breast cancer was discussed. In addition, the application value of dynamic monitoring of ctDNA methylation in plasma for postoperative recurrence risk monitoring was explored through regular postoperative follow-up of stage I-III breast cancer patients undergoing radical surgery.

NCT ID: NCT05856773 Recruiting - Breast Cancer Clinical Trials

Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy

COMPRO
Start date: March 21, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.