Open, Controlled, Multicenter Phase I/II Clinical Study of Hydroxychloroquine in Combination With Antibody-drug Conjugate Versus Antibody-drug Conjugate for Advanced Breast Cancer.
Advanced breast cancer is a special subtype of human breast cancer. Conventional guidelines recommend chemotherapy combined with other adjuvant therapies for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Trastuzumab Deruxtecan (T-DXd) and Sacituzumab Govitecan (SG) are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment. The autophagy agents hydroxychloroquine or chloroquine has become the only FDA (Food and Drug Administration) approved autophagy inhibitor, and hydroxychloroquine and antibody-drug conjugate(ADC) may have synergistic effects based on the previous work results of our research group. Therefore,we envisage that Trastuzumab Deruxtecan(T-DXd) or Sacituzumab Govitecan (SG) combined with hydroxychloroquine(HCQ) in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival. To this end, we intend to conduct a prospective,multi-center, phase I/II clinical trial to evaluate the efficacy and safety of T-DXd or SG in combination with HCQ in patients with advacned breast cancer.
NCT06328387 — Metastatic Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/metastatic-breast-cancer/NCT06328387/
Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients
Prospective pilot study on the feasibility and efficacy of a brief psychosexual support intervention in breast cancer patients undergoing hormonal therapies for at least 6 months. The study is randomized in the two following arms: Control arm (standard care pathway) Psychosexual intervention arm
NCT06327607 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06327607/
The Enigma of Subjective Lymphedema: Why do Patients Report Lymphedema After Breast Cancer Treatment Without an Objective Measurable Swelling? The Role of Sensory Processing and Subclinical Lymphedema
Breast cancer related lymphedema (BCRL) is due to its chronicity and impact an extremely dreaded complication after breast cancer treatment. The prevalence rate of objective arm and trunk/ breast BCRL is declining due to the major shift into the treatment approach of breast cancer. However, the prevalence rate of subjective arm and trunk/ breast BCRL is much higher than that of objective BCRL. Subjective BCRL is defined as the diagnosis of BCRL based on the patient's sensation of a difference in size at the arm and/or trunk without any objectively measurable swelling. At this moment, it is not clear how many breast cancer patients experience subjective arm or trunk/breast BCRL and what the underlying mechanisms may be. Therefore, the investigators hypothesize that four mechanisms might be associated with the presence and the severity of subjective arm or trunk/breast BCRL, including sensory processing problems (1. nociceptive and/or 2. neuropathic and/or 3. central) and the presence of disturbed lymphatic transport without clinical manifestation (4. subclinical BCRL). The investigators will set up a prospective longitudinal study with breast cancer patients to determine the prevalence of subjective and objective arm or trunk/ breast BCRL at 1, 6. and 12 month(s) post-surgery and the transitions between the different types of BCRL and to compare the amount of swelling at arm or trunk/ breast, the presence or severity of subclinical BCRL and peripheral and central sensory processing problems between patients with different types of BCRL. In addition, the present study will be undertaken to determine the contributing factors to the severity of subjective arm or trunk/ breast BCRL within the group of patients with subjective BCRL at different time-points after surgery (at 1, 6. and 12 month(s) post-surgery).
NCT06324721 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06324721/
Clinical Evaluation of a Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Triple Negative Breast Cancer (TNBC)
This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing.
NCT06324240 — Anatomic Stage III Breast Cancer AJCC v8
Status: Not yet recruiting
http://inclinicaltrials.com/anatomic-stage-iii-breast-cancer-ajcc-v8/NCT06324240/
The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy
This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not.
NCT06318507 — Breast Neoplasms
Status: Recruiting
http://inclinicaltrials.com/breast-neoplasms/NCT06318507/
Breast Cancer Subtype Characterization Through Patient's Derived Organoids". (BCinsightPDO)
Development of tools to predict patients chemo-sensitivity and identification of corresponding biomarkers is an urgent challenge for BC patients lacking targeted therapies, such as TNBC, or for patients experiencing relapse after adjuvant chemotherapy or targeted therapies. The refinement of 3D-cultivation techniques, experienced in the last decade, has allowed cultivation of patients-derived cancer cells in organotypic structures, named patient-derived organoids (PDO), which preserve histologic, genomic and transcriptomic features of primary tumors. PDO allow propagation, pharmacological treatment and genetic manipulation of patients-derived cancer cells in a close to physiology setting, thus representing a promising tool in the development of personalized therapies
NCT06315868 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06315868/
Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study
This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.
NCT06314906 — Nausea and Vomiting
Status: Recruiting
http://inclinicaltrials.com/nausea-and-vomiting/NCT06314906/
A Phase Ⅲ Randomized, Open Label, Parallel, Multicenter To Assess Efficacy and Safety Study of Hemay022 in Combination With AI In Postmenopausal HER2+/ER+ Advanced Breast Cancer Patients Treated With Trastuzumab-containing Regimens
The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI, and the safety of Hemay022 in combination with AI. The trial plans to recruit 339 subjects, who will be randomly divided into two cohorts (the experimental group is hemay022 combined with AI, and the control group is lapatinib combined with capecitabine). During the treatment period, imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated, etc.
NCT06313983 — Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/breast-cancer/NCT06313983/
A Prospective, Observational Clinical Study of AMH Predicting Postchemotherapy Menopause in Premenopausal Breast Cancer Patients Who do Not Use OFS
To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause
NCT06313476 — Breast Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/breast-cancer/NCT06313476/
A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer
A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer
NCT06313086 — HER2-positive Breast Cancer
Status: Recruiting
http://inclinicaltrials.com/her2-positive-breast-cancer/NCT06313086/