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Breast Neoplasms clinical trials

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NCT ID: NCT06246084 Not yet recruiting - Breast Cancer Clinical Trials

INTENT Pilot Study - Enhancing Adherence Intentions to Endocrine Therapy

Start date: July 2024
Phase: N/A
Study type: Interventional

This research is being done to pilot an intervention which aims to improve participants' experiences on Endocrine Therapy. The name of the intervention used in this research study is: Endocrine Therapy Education Program (a brief, video-based intervention)

NCT ID: NCT06245889 Recruiting - Clinical trials for Triple Negative Breast Cancer

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

NeoADAPT
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4 cycles of neoadjuvant paclitaxel/carboplatin/pembrolizumab. A PET scan will be performed at baseline and after 1 cycle of therapy. A breast MRI will be performed after treatment completion. Patients with complete clinical response will proceed to surgery. Patients with clinical residual disease will complete neoadjuvant rescue with 4 cycles of doxorubicin/cyclophosphamide prior to surgery. If residual disease identified after surgery, adjuvant therapy to be determined by the treating oncologist (may include doxorubicin/cyclophosphamide/pembrolizumab, capecitabine etc).

NCT ID: NCT06245824 Not yet recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (T-DXd) With Pyrotinib in First-line HER2-positive Unresectable or Metastatic Breast Cancer Trial

Start date: January 30, 2024
Phase: Phase 4
Study type: Interventional

This is an exploratory, single-arm, multi-center study to assess the efficacy and safety of T-DXd combined with pyrotinib as the first-line treatment of HER2-positive metastatic breast cancer. This study is planned to recruit 3 to 12 patients in safety run-in (Part A) and 39 to 42 patients in dose expansion (Part B) in several investigational sites in China. The total number of patients enrolled in the study will be 45 to 51. Among them, 45 patients will start at the recommended dose. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will receive T-DXd combined with pyrotinib until confirmed progressive disease. Patients will attend a safety follow up visit 40 days after last dose of T-DXd with pyrotinib. There are two main parts to this study; Part A, Combination dose finding and Parts B, Dose expansion. Tumor assessments will be performed at Screening as baseline with follow-up every 9 weeks(±7 days) from the date of first dosing date of T-DXd with pyrotinib for 54 weeks, and then every 12 weeks (±7 days) until confirmed objective disease progression. Primary Objective for Part A: To define the recommended dose of pyrotinib combined with T-DXd Recommended dose Secondary Objective for Part A: To investigate the safety and tolerability of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer. Primary Objective for Part B : To determine the efficacy of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer. Secondary Objective for Part B : To further determine the efficacy of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer and To further evaluate the safety and tolerability profile of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer.

NCT ID: NCT06243796 Active, not recruiting - Breast-cancer Clinical Trials

Seroma Formation After Modified Radical Mastectomy With Flap Fixation Technique in Breast Cancer Patients

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

The goal of this clinical trial is to evaluate the effectiveness of mastectomy flap fixation in breast cancer patients. The main questions it aims to answer are: - To compare seroma formation after mastectomy flap fixation with conventional surgery in breast cancer patients Participants will be randomly divided into 2 groups, 1. Mastectomy flap fixation 2. Conventional surgery with non flap fixation. Researchers will record the amount and color of drainage fluid, patient and tumor characteristics, and operative related factor after surgery. Researchers will compare with conventional surgery to see if seroma formation, and wound infection.

NCT ID: NCT06243432 Recruiting - Clinical trials for Advanced Breast Carcinoma

Estrogen Receptors and HER2 Levels' Expression in Luminal Metastatic Breast Cancer

CYCLHER
Start date: February 1, 2023
Phase:
Study type: Observational

CYCLHER is a retrospective observational multicentric italian study aimed to evaluate the correlation between hormone receptors (HR) and HER2 immunohistochemistry (IHC) levels and treatment'response in patients affected by advanced breast cancer treated with first line CDK4/6 inhibitor plus endocrine therapy.

NCT ID: NCT06240195 Recruiting - Breast Cancer Clinical Trials

Biomarkers of Efficacy and Tolerability of Sacituzumab-Govitecan in the Treatment of Patients With Triple-negative Breast Cancer in the Metastatic Phase: Prospective Multicenter Real-world Study

BIO-PROSA
Start date: January 17, 2023
Phase:
Study type: Observational

Observational, prospective, multicenter study. Collection of data relating to the effectiveness of sacituzumab govitecan SG, in a real-world context and planned research of predictive biomarkers of efficacy/tolerability carried out on multiple platforms at the center coordinator.

NCT ID: NCT06239766 Completed - Breast Cancer Clinical Trials

BC Risk Assessment Before Top Surgery

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

The population of transgender and gender-diverse (TGD) persons in Wisconsin and the U.S. is steadily increasing. As this population grows, the number of individuals seeking gender-affirming therapies, including gender-affirming operations and gender-affirming hormone therapy, is also growing. An example of gender-affirming surgery is chest masculinization surgery, in which most breast tissue is removed in a person assigned female or intersex at birth to allow the chest to appear masculine. Gender-affirming chest masculinization surgery is not generally considered equivalent to an oncologic mastectomy, which aims to removal all breast tissue for future breast cancer reduction or current breast cancer treatment. The goals of this investigation are to 1) determine the percent of TGD persons considering chest masculinization surgery who have an elevated lifetime risk of breast cancer development and/or a pathogenic genetic mutation; 2) measure the percent who are at risk and choose to undergo risk-reducing mastectomies as part of chest masculinization surgery; and 3) assess and compare self-perceived breast cancer risk with calculated risk. The results of this study will substantially inform TGD patients and surgeons on the utility of personalized breast cancer risk assessment prior to chest masculinization surgery and the accuracy of self-perceived breast cancer risk in TGD persons.

NCT ID: NCT06239467 Recruiting - Breast Cancer Clinical Trials

First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

PIKture-01
Start date: March 1, 2024
Phase: Phase 1
Study type: Interventional

OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with fulvestrant or trastuzumab. Phase 1a (Part A) will investigate escalating doses of OKI-219 monotherapy, and Phase 1b will investigate OKI-219 (at a tolerated dose determined in Part A) in combination with standard dose fulvestrant (Part B) or standard dose trastuzumab (Part C). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met.

NCT ID: NCT06238986 Recruiting - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy

Start date: March 22, 2024
Phase:
Study type: Observational

This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.

NCT ID: NCT06238921 Not yet recruiting - Breast Cancer Clinical Trials

Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

Start date: June 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone.