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Ductal Carcinoma In Situ clinical trials

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NCT ID: NCT06218303 Recruiting - Clinical trials for Ductal Carcinoma in Situ

Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Start date: February 7, 2024
Phase: Phase 1
Study type: Interventional

Post-menopausal women with biopsy-proven DCIS will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor alone for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.

NCT ID: NCT06133647 Recruiting - Clinical trials for Ductal Carcinoma in Situ

Demographics, Characteristics and Outcomes of Male Breast Cancer Patients at Methodist Health System

Start date: May 4, 2023
Phase:
Study type: Observational

To determine the number of MBC cases as well as the demographics, characteristics, and outcomes of MBC patients at Methodist Health System (MHS).

NCT ID: NCT06075953 Recruiting - Clinical trials for Ductal Carcinoma in Situ

DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

Start date: February 14, 2024
Phase: Phase 2
Study type: Interventional

The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease. Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.

NCT ID: NCT06033092 Not yet recruiting - Clinical trials for Ductal Carcinoma in Situ

Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion

TOLERANT
Start date: May 2024
Phase: Phase 2
Study type: Interventional

Circulating levels of Sex Hormone Binding Globulin (SHBG) are significantly associated with a decreased risk of breast cancer. The main aim of this clinical trial is to verify whether Low Dose Tamoxifen (LDT) increases circulating levels of SHBG more than lifestyle intervention (LI) with or without intermittent caloric restriction (ICR) after 6 months in women at increased risk of breast cancer (i.e., healthy participants carriers of a germline pathogenic/likely pathogenetic variant in at least one of the following genes: BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, RAD51C or RAD51D, or with > 5% breast cancer risk at 10 years, using the Tyrer Cuzick or the Breast Cancer Surveillance Consortium Risk models or with a recently resected intraepithelial neoplasia of the breast (IEN). The secondary aims are: - to verify whether ICR significantly modulates primary and secondary endpoints such as Homeostasis Model Assessment (HOMA) index, immune and inflammatory markers, lipid profile, Adiponectin/Leptin (A/L) ratio, quality of life (QoL), Body mass index (BMI), fat body composition, safety and toxicity; - to verify whether LDT significantly modulates secondary endpoints, such as HOMA-index, immune and inflammatory markers, lipid profile, A/L ratio, QoL, BMI, fat body composition, safety and toxicity; - to investigate differences in microbiome composition by arms and the effect of changes in microbiome on QoL taking into account circulating biomarkers, cytokines, immune modulators, and inflammatory proteins in serum; - to investigate MD (Mammographic Breast Density) changes by LDT vs. LI, with or without ICR. This aim will be performed in a subgroup of participants (not all the participants will undergo mammography due to younger age).

NCT ID: NCT05961280 Completed - Clinical trials for Ductal Carcinoma in Situ

Selective Omission of Sentinel Lymph Node Biopsy in Mastectomy for Ductal Carcinoma in Situ: Identifying Eligible Candidates

Start date: January 1, 2010
Phase:
Study type: Observational

This study aimed to assess the prevalence of upgrade to invasive breast cancer and axillary lymph node metastasis in patients who were diagnosed with DCIS on biopsy and subsequently underwent mastectomy with axillary surgery to establish the need for SLNB. Furthermore, we explored the clinicopathologic features related to the upgrade to invasive breast cancer and axillary lymph node metastasis.

NCT ID: NCT05932758 Recruiting - Clinical trials for Ductal Carcinoma in Situ

Excisional Vacuum-Assisted Breast Biopsy

Start date: January 17, 2023
Phase: N/A
Study type: Interventional

The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).

NCT ID: NCT05218044 Recruiting - Clinical trials for Ductal Carcinoma in Situ

Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

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

Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.

NCT ID: NCT05032079 Withdrawn - Clinical trials for Ductal Carcinoma in Situ

Subzero and Scorpion Trial

Start date: November 16, 2020
Phase: N/A
Study type: Interventional

This is a prospective single-institution pilot study examining the feasibility of performing ultrasound-guided cryoablation to completely ablate breast ductal carcinoma in situ (DCIS). The study is designed such that patients meeting selection criteria will undergo cryoablation followed by surgical resection. The pathology of the surgical specimen will be used to determine the rate of complete tumor ablation. Standard adjuvant therapies otherwise remained unchanged.

NCT ID: NCT04985032 Recruiting - Clinical trials for Ductal Carcinoma in Situ

Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

Start date: August 15, 2022
Phase:
Study type: Observational [Patient Registry]

This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years

NCT ID: NCT04866992 Completed - Clinical trials for Anatomic Stage II Breast Cancer AJCC v8

Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)

SPrNSM
Start date: February 1, 2020
Phase:
Study type: Observational

This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.