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Breast Cancer clinical trials

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NCT ID: NCT05485766 Recruiting - Breast Cancer Clinical Trials

Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

Start date: February 29, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II, single-arm, open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA (gBRCA) 1/2 mutated triple negative breast cancer (TNBC). Pembrolizumab in combination with weekly paclitaxel and carboplatin (treatment 1) is followed by Pembrolizumab in combination with Olaparib (treatment 2) in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied

NCT ID: NCT05483712 Recruiting - Breast Cancer Clinical Trials

Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

Start date: January 18, 2023
Phase: N/A
Study type: Interventional

The hypothesis is that the daily use of brass mesh bolus achieves a comparable dose to every-other-day use of Superflab bolus (current standard of care) in chest wall post-mastectomy patients treated with rotational 6 MV photon delivery.

NCT ID: NCT05483491 Recruiting - Breast Cancer Clinical Trials

KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer

Start date: September 26, 2022
Phase: Phase 1
Study type: Interventional

This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined.

NCT ID: NCT05483283 Recruiting - Breast Cancer Clinical Trials

Empowering Vulnerable and Resilient Latinas to Obtain Breast Cancer Care

Start date: January 18, 2023
Phase: N/A
Study type: Interventional

The investigator and study staff will identify, recruit and randomize Latina participants with elevated genetic and Social Determinants of Heath (SDH) risks. Within 1 week of enrollment, all Latina Aim 1 participants in both study arms will engage in three 30-minute, individual, phone-based sessions with the study team across 3 consecutive weeks

NCT ID: NCT05475678 Recruiting - Breast Cancer Clinical Trials

Clinical Study of Camrelizumab Combined With TCb Versus TCb in Neoadjuvant Treatment of Triple-negative Breast Cancer

Start date: December 20, 2022
Phase: Phase 2
Study type: Interventional

Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored. Camrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety. Therefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.

NCT ID: NCT05472792 Recruiting - Breast Cancer Clinical Trials

Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN)

CAMERAN
Start date: May 17, 2022
Phase: Phase 2
Study type: Interventional

The aim of this prospective study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomized to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy. The study population will include women age 65 years and older with low-risk tumor characteristics (tumor size <2cm, grade 1-2, node-negative). APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. Quality of life outcomes will be measured at 1 year following lumpectomy and compared between groups. We hypothesize that the use of APBI may be superior in terms of quality of life when compared to endocrine therapy alone following lumpectomy while providing equivalent rates of disease control and overall survival. In this phase II study, we anticipate enrolling 90 women at N.C. Cancer Hospital in Chapel Hill, NC.

NCT ID: NCT05472532 Recruiting - Breast Cancer Clinical Trials

Evaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)

INOVOLINE
Start date: February 14, 2023
Phase: N/A
Study type: Interventional

A variety of in vivo experimental models have been established for the studies of human cancer using both cancer cell lines and patient-derived xenografts (PDXs). In order to meet the aspiration of precision medicine, the in vivo murine models have been widely adopted. However, common constraints such as high cost, long duration of experiments, and low engraftment efficiency remained to be resolved. The chick embryo chorioallantoic membrane (CAM) is an alternative model to overcome some of these limitations. The chick CAM is shown to be a robust model for both the inoculation of cell lines and grafting of patient tumors for drug therapy evaluations and target genes/pathways analysis. The start-up INOVOTION has developed a unique, highly sensitive and reproducible CAM assay to graft human cancer cells/tumors in the chicken egg environment. INOVOTION's technology was validated for over 55 human tumor cell lines, including carcinomas, gliomas and melanomas, as well as over 30 reference drugs currently on the market. At INOVOTION, the graft of human cancer cells on the chicken CAM is currently conducted manually. To scale-up, the process was recently automated. The automation performance was assessed on cancer cells lines. The objective of this study is to demonstrate that the automation of the INOVOTION process enables tumors' proliferation using patient samples (from tumor samples or circulating tumor cells) as grafting material.

NCT ID: NCT05470348 Recruiting - Breast Cancer Clinical Trials

A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

Start date: August 11, 2022
Phase: Phase 1
Study type: Interventional

In this study, the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase II dose (RP2D), the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 will be investigated in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors.

NCT ID: NCT05468034 Recruiting - Breast Cancer Clinical Trials

Exercise in Metastatic Breast Cancer: EMBody

Start date: April 26, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to study exercise in a novel population with indolent MBC (no progression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensity aerobic and resistance training exercise for 16 weeks in this population will significantly improve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass), all established predictors of survival, and 2) patient- reported outcomes.

NCT ID: NCT05466760 Recruiting - Breast Cancer Clinical Trials

PET/MR Radiomics for Breast Cancer Diagnosis

Start date: July 6, 2018
Phase:
Study type: Observational [Patient Registry]

Breast cancer is the most common malignancy in women in our country (2013 cancer registry report, Health Promotion Administration). MRI is a more accurate imaging modality for breast lesion diagnosis, monitoring of treatment response, and local staging than compared with mammography and ultrasound. ¹⁸ F-FDG PET was reported to be used for breast cancer diagnosis, staging, and prediction of treatment response as well. We usually interpret the aforementioned imaging modalities by qualitative methods for decision-making. Radiomics is a process involving the conversion of images to quantitative data for subsequent data mining to improve decisional making for patient care, to adjust the patient management, that is so-called precision medicine. Our study is to use semantic and agnostic features of radiomics by hybrid PET/MR for 1. The pre-operative breast cancer patients (without neoadjuvant chemotherapy before operation). 2. The patients will receive neoadjuvant chemotherapy (NAC). The study intends to investigate the association of PET/MR radiomics data with the probability of metastasis or risk of recurrences and survival. We will also investigate if the BD and BPE (measured on MRI) are associated with molecular subtypes, histologic grade and clinical outcome, risk of metastases, and long-term survival of breast cancer patients for the study participants.