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Breast Cancer clinical trials

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NCT ID: NCT05501886 Recruiting - Breast Cancer Clinical Trials

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

VIKTORIA-1
Start date: September 30, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

NCT ID: NCT05501769 Active, not recruiting - Breast Cancer Clinical Trials

ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer

TACTIVE-E
Start date: September 8, 2022
Phase: Phase 1
Study type: Interventional

A phase 1b study to assess the combination of ARV-471 and everolimus in participants with advanced or metastatic ER+/HER2- breast cancer.

NCT ID: NCT05501158 Active, not recruiting - Breast Cancer Clinical Trials

CYP2D6 Genotypes and Breast Cancer Clinical Outcomes in the Indonesian Population

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

The utilization of tamoxifen is considerably high in Indonesia, with about 170,000 tamoxifen prescriptions filed in 2015. It is metabolized by the enzyme CYP2D6, resulting in its active metabolite, endoxifen, which has been proven to be effective in the prevention and treatment of breast cancer. Studies showed the CYP2D6 gene has more than 100 variants; some of which are linked with reduced drug activity, while others do not have any pathological implications. The metabolizer profile of these variants is generally grouped into Ultra-rapid, Normal, Intermediate, and Poor Metabolizers (UM, NM, IM, and PM, respectively). In our previous study (NCT04312347), the investigators recruited 150 breast cancer patients who were taking adjusted dose of tamoxifen daily based on their CYP2D6 phenotype. Although the investigators have measured the endoxifen level of the patients with adjusted treatment, the clinical outcomes of the study are not yet conclusive.

NCT ID: NCT05500508 Recruiting - Breast Cancer Clinical Trials

Oral AMXT 1501 Dicaprate in Combination With IV DFMO

Start date: November 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1B/2A study will be conducted to establish safety and dose level of AMXT 1501 dicaprate in combination with IV DFMO, in cancer patients.

NCT ID: NCT05498311 Recruiting - Breast Cancer Clinical Trials

Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

IORT_BREAST
Start date: October 20, 2016
Phase: Phase 2
Study type: Interventional

To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

NCT ID: NCT05498155 Active, not recruiting - Breast Cancer Clinical Trials

Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer

OlympiaN
Start date: November 7, 2022
Phase: Phase 2
Study type: Interventional

This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems. Olaparib is a type of drug called a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor. PARP inhibitors can destroy cancer cells that are not good at repairing DNA damage. Olaparib is also approved by US Food and Drug Administration (FDA), European Medicines Agency (EMA) and in other countries for treating women with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. Durvalumab is a type of anticancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell. Your immune system can then attack and kill the cancer cells. Durvalumab is approved by the FDA and the EMA for the treatment of patients with locally advanced non-small cell lung cancer after receiving chemoradiation therapy and extensive-stage small cell lung cancer in combination with chemotherapy. Some parts of this study are experimental, which means that durvalumab and the combination of olaparib and durvalumab are still in the development stage for the treatment of breast cancer, and they are not approved for treatment of breast cancer, except for use in research studies like this.

NCT ID: NCT05496829 Recruiting - Breast Cancer Clinical Trials

IMPACT Trial: Intervention to iMProve AdherenCe Equitably

Start date: March 2, 2023
Phase: N/A
Study type: Interventional

To determine the efficacy of a multicomponent adherence intervention among participants with early-stage breast cancer on endocrine therapy and at least one oral cardiovascular disease (CVD) medication on adherence to endocrine therapy and to CVD medication at 24 weeks assessed by self-report using the Domains of Subjective Extent (DOSE)-Nonadherence questionnaire and also by pharmacy fill data assessed in the electronic health record (EHR).

NCT ID: NCT05496101 Recruiting - Clinical trials for Breast Cancer Female

CLI and FAR for Intraoperative Margin Assessment

CLI-FAR
Start date: November 21, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, single arm interventional study to evaluate the diagnostic accuracy of intraoperative Cerenkov luminescence imaging (CLI) plus flexible autoradiography (FAR) using the LightPath® Imaging System for intraoperative tumour margin assessment compared to post-operative standard-of-care histopathology in women undergoing breast-conserving surgery for breast cancer.

NCT ID: NCT05491694 Not yet recruiting - Breast Cancer Clinical Trials

To Evaluate the Efficacy of Toripalimab Combined With Chemotherapy After HIFU Induction in the Treatment of Early Triple-negative Breast Cancer

HIFU
Start date: September 1, 2022
Phase: Phase 2
Study type: Interventional

To investigate the efficacy and safety of terbinumab combined with chemotherapy (epirubicin + cyclophosphamide → nab-paclitaxel + carboplatin) in neoadjuvant therapy of triple-negative breast cancer after HIFU.

NCT ID: NCT05491395 Recruiting - Breast Cancer Clinical Trials

Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction

PROMART
Start date: June 27, 2022
Phase: N/A
Study type: Interventional

RATIONALE: Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. The biological explanation of this outcome is not fully understood, but recent advances in the analysis of patient-derived blood can contribute to establishing a connection of molecular alterations related to this clinical outcome. There is not a consensus about using hypofractionated RT schemes for patients with BCS and breast reconstruction since no studies had investigated the reasons why some patients lose the prosthesis. PURPOSE: This study will evaluate G3 toxicity rate in breast cancer patients with immediate prosthetic reconstruction, submitted to hypofractionated radiotherapy, analyzing capsular contracture, leakage, infection, and bad positioning in order to demonstrate the noninferiority of Hypo-RT with the conventional RT. Additionally, the molecular profile of blood samples will be investigated in order to find biomarkers related to inflammations processes and response to treatment.