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Breast Neoplasms clinical trials

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NCT ID: NCT05561686 Not yet recruiting - Clinical trials for HER2-positive Breast Cancer

Real-world Study of Pyrotinib in Neoadjuvant Therapy for HER2-positive Breast Cancer

Start date: October 1, 2022
Phase:
Study type: Observational

Pyrotinib is currently being investigated in both registration studies and investigator-initiated studies in the neoadjuvant and adjuvant setting for HER2-positive breast cancer, all of which are RCTs, but randomized clinical studies have selected specific populations in defined settings, which may differ from the actual clinical setting. Given the limited real-world data on pyrotinib, real-world studies focusing on neoadjuvant therapy have not been reported. At present, we hope to collect the data of neoadjuvant therapy for HER2-positive breast cancer patients who have been prescribed pyrotinib, and explore the efficacy and safety of pyrotinib-based neoadjuvant therapy for HER2-positive early or locally advanced breast cancer patients; exploratory analysis to explore the correlation between TMB levels and pCR rate of neoadjuvant therapy in HER2-positive breast cancer patients, and the effect of pyrotinib-based neoadjuvant therapy on intestinal flora.

NCT ID: NCT05560308 Not yet recruiting - Clinical trials for HER2+ Advanced Breast Cancer Patients Progressing on TKI Therapy

Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic Breast Cancer Who Had Progressed on TKI Therapy

Start date: September 30, 2022
Phase: N/A
Study type: Interventional

This trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design. Preliminary efficacy and safety in patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy.

NCT ID: NCT05539365 Not yet recruiting - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer

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

This phase II trial tests the safety, side effects, and whether dendritic cell-based treatment and pembrolizumab work in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). The term triple-negative breast cancer refers to the fact that the cancer cells don't have estrogen or progesterone receptors (ER or PR) and also don't make any or too much of the protein called HER2 (the cells test "negative" on all 3 tests). Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. Pembrolizumab, is an immune checkpoint inhibitor drug, that works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Giving dendritic cell-based therapy and pembrolizumab may decrease symptoms and improve quality of life in patients with triple negative breast cancer.

NCT ID: NCT05538000 Not yet recruiting - Clinical trials for No Metastatic Breast Cancer

Personalized Preventive Support for Cognitive Impairment in Non-Metastatic Breast Cancer (EFACog)

EFACog
Start date: May 2024
Phase: N/A
Study type: Interventional

EFACog is a single-center prospective cohort feasibility study conducted on a single group of patients to study the feasibility of a personalized support program by a nurse conducted over 9 months, using face-to-face and telephone interviews. The objective of this support program is to prevent the occurrence of post-chemotherapy cognitive impairment. After a pre-inclusion visit, patients with no pre-existing cognitive impairment will be included in the study and will receive a 9-month follow-up after the first course of chemotherapy. All follow-up visits (telephone or face-to-face) will be scheduled in conjunction with those taking place in the care setting.

NCT ID: NCT05536128 Not yet recruiting - Clinical trials for Advanced Breast Cancer

Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor

Post-CDK
Start date: December 31, 2022
Phase: Phase 2
Study type: Interventional

Protocol Title: A Phase II open label, umbrella study evaluating the efficacy and safety of Fulvestrant plus DNA damage repair inhibitors in hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor

NCT ID: NCT05519670 Not yet recruiting - Breast Cancer Clinical Trials

A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr

CAPRICE
Start date: March 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study will be to combine oral capecitabine and oral niraparib such thz association may increase clinical benefits of PARP inhibitors in germline BRCA mutated HER2 negative advanced breast cancer patients.

NCT ID: NCT05512416 Not yet recruiting - Breast Cancer Clinical Trials

Neoadjuvant Dalpiciclib Plus Letrozole for HR+/HER2- Breast Cancer

Start date: August 2022
Phase: Phase 2
Study type: Interventional

In this single arm, open label, phase 2 trial, operable patients with stage IIB-III HR+/HER2- breast cancer will be enrolled and receive six cycles of adjuvant dalpiciclib plus letrozole. This study aims to assessed the biological effects and safety of dalpiciclib in combination with letrozole for HR+/HER2- breast cancer in the neoadjuvant setting.

NCT ID: NCT05512286 Not yet recruiting - Breast Cancer Clinical Trials

Patient-Reported Outcome and Safety Between Preoperative and Postmastectomy Radiotherapy in DIEP Flap Reconstruction

CAPPELLA
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This study is the first prospective randomized study assessing the patient-reported outcomes and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction of deep inferior epigastric perforator(DIEP) flap. Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. We aimed to explore the feasibility of preoperative radiotherapy followed by DIEP flap reconstruction in patients with breast cancer requiring mastectomy.

NCT ID: NCT05507398 Not yet recruiting - Clinical trials for Breast Cancer Female

The Anti-tumor Effect of Metformin And Atorvastatin in Breast Cancer

Start date: October 2022
Phase: Phase 4
Study type: Interventional

This study aims at evaluating and comparing the anti-tumor effects of metformin and statins (hydroxyl-methyl-glutaryl-CoA reductase inhibitors) in patients with non-metastatic breast cancer (stage I, II, & III).

NCT ID: NCT05505812 Not yet recruiting - Breast Cancer Clinical Trials

Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes for the Treatment of Advanced Breast Cancer

Start date: October 8, 2022
Phase: Early Phase 1
Study type: Interventional

Prospective, single-center, single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced breast cancer.