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Carcinoma, Ductal clinical trials

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NCT ID: NCT06302569 Not yet recruiting - Clinical trials for Renal Medullary Carcinoma

Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma

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

This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin. Approximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice. Patients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin. The study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes.

NCT ID: NCT06211114 Not yet recruiting - Clinical trials for Collecting Duct Carcinoma

Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma

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

This is a phase II trial to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with axitinib for previously treated advanced collecting duct carcinoma.

NCT ID: NCT06195306 Not yet recruiting - Breast Carcinoma Clinical Trials

Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction

Start date: June 16, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk.

NCT ID: NCT06184750 Not yet recruiting - Breast Carcinoma Clinical Trials

Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial

Start date: August 3, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.

NCT ID: NCT06182072 Not yet recruiting - Clinical trials for Pancreatic Ductal Carcinoma

ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

Start date: December 29, 2023
Phase: Phase 1
Study type: Interventional

This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic pancreatic ductal adenocarcinoma (PDAC)

NCT ID: NCT06135896 Not yet recruiting - Clinical trials for Unresectable Pancreatic Cancer

Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers

Dulastin
Start date: December 10, 2023
Phase: Phase 2
Study type: Interventional

- Clinical trial phase: Phase 2 - Intervention model: Control group - Group allocation: Randomized controlled trial - Research perspective: Prospective study - Participating centers: Multicenter study - Definition of the intervention period: Based on the RECIST 1.1 guidelines, patients will receive treatment until dropout due to disease progression or unacceptable toxicity related to the trial drug. Patients will be followed up with to assess survival every 2 months until either death or the end of the trial, whichever is first. - The intervention period is from the date of IRB approval to December 31st, 2025 - The follow-up duration is one year, and the statistical analysis duration is six months - The total research period is from the date of IRB approval to June 30th, 2026

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: NCT05941520 Not yet recruiting - Breast Carcinoma Clinical Trials

Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer. The usual approach for patients at increased risk for breast cancer is to undergo yearly breast magnetic resonance imaging (MRI) or ultrasound in addition to yearly mammogram. Premenopausal women at very high lifetime risk for breast cancer (greater than 50%) can consider preventive removal (mastectomy) of both breasts. Premenopausal women age 35 or older with a prior diagnosis of atypical hyperplasia, lobular carcinoma in situ, or an estimated 10-year risk of greater than or equal to 3% or estimated 10-year risk of greater than or equal to 2-5 times that of the average woman (depending on age) may be advised to consider five years of standard dose tamoxifen. Standard dose tamoxifen is four times the dose used in this study. Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen blocks the use of estrogen by breast cells. This study may help researchers measure the effects of acolbifene and low dose tamoxifen on markers of breast cancer risk in mammogram imaging, breast tissue, and in blood samples.

NCT ID: NCT05703815 Not yet recruiting - Clinical trials for Invasive Breast Cancer

EpCAM and p53 Expressions in Infiltrating Duct Carcinoma of the Breast

Start date: January 2023
Phase:
Study type: Observational

Breast cancer represents the most frequently diagnosed cancer in women. It represents the 5th leading cause of cancer mortality all over the world. In Egypt, breast cancer represents the 2nd most diagnosed cancer among all population. But among Egyptian females it represents the 1st diagnosed cancer representing 32.4%. The main cause of death in breast cancer patients is tumor metastasis. Although only 5-10% of recently diagnosed breast cancer cases show metastasis to distant sites, but still there is a high risk for metastasis in patients with localized primary tumor following successful surgical management. Epithelial cell adhesion molecule (EpCAM) is a cell adhesion molecule. It modifies cadherin mediated cell adhesion and it induces epithelial cell migration and proliferation. Some authors elucidate that EpCAM is involved in metastasis. P53 is a known tumor suppressor gene involved in the control of cell cycle, DNA repair and apoptosis. It's one of the most mutated genes in cancer including breast cancer. Mutant p53 has a big role in tumor progression.

NCT ID: NCT04985357 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Defining the Clinical Potential of Mass Response as a Biomarker for Patient Tumor Sensitivity to Drugs

Start date: June 2024
Phase:
Study type: Observational

The primary objective of this study, sponsored by Travera in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from varying cancers and biopsy formats.