Active clinical trials for "Breast Neoplasms"

This phase I trial studies the side effects and best dose of olaparib when given with hyperthermia in treating patients with breast cancer that has come back in the chest wall. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hyperthermia treatment may kill or damage tumor cells by heating them to several degrees above normal body temperature. Giving olaparib and hyperthermia treatment may work better in treating patients with breast cancer that has come back in the chest well compared to standard of care.

Triple negative breast cancer (TNBC), characterized by estrogen receptor, progesterone receptor and HER2 negative, accounts for 10-20% of all breast cancers and usually occurs in young women. It is an aggressive and worst prognosis breast cancer subtype, which urgently requires effective treatment.The pathological complete response (pCR) of neoadjuvant therapy is associated with disease-free survival (DFS) and overall survival (OS) of breast cancer. The correlation between pathological response and long-term survival in patients with early-stage breast cancer is the strongest among patients with triple-negative breast cancer.

This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。

The purpose of this study is to evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery

This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery. The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application. The total number of patients to be included in this study is 520 patients.

The proposed study is a randomized, parallel-group, placebo-controlled, subject- and assessor-blind trial. It is designed according to CONSORT and STRICTA recommendations. The 138 subjects will be randomly assigned to one of the two arms using block randomization in a 1:1 ratio: (I) acupuncture treatment, and (II) sham treatment. In groups (I) and (II), acupuncture or sham acupuncture treatment will be given twice a week for 6 weeks (12 sessions). A maintenance tapering treatment schedule will then be applied once per month for 3 months (3 sessions). The primary outcome will be improvement in sleep quality as measured by the change of ISI after 6 weeks of treatment. Secondary outcome assessment tools will include PSQI, HADS, BPI, BFI, FACT-B, sleep diaries, drug diaries, blinding success questionnaire and reports of adverse events. The subjects will be scheduled for on-site follow-up assessments at 3 and 6 months after the last treatment. An intention to treat (ITT) approach will be used for data analysis.

It has been well established that malignant tumors tend to have low levels of oxygen and that tumors with very low levels of oxygen are more resistant to radiotherapy and other treatments, such as chemotherapy and immunotherapy. Previous attempts to improve response to therapy by increasing the oxygen level of tissues have had disappointing results and collectively have not led to changing clinical practice. Without a method to measure oxygen levels in tumors or the ability to monitor over time whether tumors are responding to methods to increase oxygen during therapy, clinician's reluctance to use oxygen therapy in usual practice is not surprising. The hypothesis underlying this research is that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, including combined therapy, and to minimize normal tissue side effects or complications. Because studies have found that tumors vary both in their initial levels of oxygen and exhibit changing patterns during growth and treatment, we propose to monitor oxygen levels in tumors and their responsiveness to hyperoxygenation procedures. Such knowledge about oxygen levels in tumor tissues and their responsiveness to hyper-oxygenation could potentially be used to select subjects for particular types of treatment, or otherwise to adjust routine care for patients known to have hypoxic but unresponsive tumors in order to improve their outcomes. The overall objectives of this study are to establish the clinical feasibility and efficacy of using in vivo electron paramagnetic resonance (EPR) oximetry-a technique related to magnetic resonance imaging (MRI)-to obtain direct and repeated measurements of clinically useful information about tumor tissue oxygenation in specific groups of subjects with the same types of tumors, and to establish the clinical feasibility and efficacy of using inhalation of enriched oxygen to gain additional clinically useful information about responsiveness of tumors to hyper-oxygenation. Two devices are used: a paramagnetic charcoal suspension (Carlo Erba India ink) and in vivo EPR oximetry to assess oxygen levels. The ink is injected and becomes permanent in the tissue at the site of injection unless removed; thereafter, the in vivo oximetry measurements are noninvasive and can be repeated indefinitely.

This study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced and/or metastatic breast cancer, including Cohort 1 and Cohort 2. Each cohort will enroll 30-60 cases.

The objective of the study is to evaluate the effectiveness of telemonitoring in the dysfunctions of the upper limbs in activities of daily living, quality of life and prevention of lymphedema in women undergoing treatment for breast cancer. Secondarily, to analyze the degree of satisfaction in the proposed treatment modality. This is a randomized controlled trial, double blind (evaluator and patient), parallel in three groups (synchronous telemonitoring group, asynchronous telemonitoring group and control group). The protocol will last six weeks, and quality of life, upper limb functionality, and risk of lymphedema will be evaluated. Both intervention groups will be submitted to a kinesiotherapy program three times a week, with synchronous and asynchronous monitoring, while the control group will receive usual post cancer orientations. Kinesiotherapy protocol in synchronous form compared to the usual recommendations in remote form is expected to show superior result in upper limb function and quality of life of women after breast cancer.

Objectives Phase 1b Primary Objectives: To evaluate the safety and tolerability of X4P-001 combined with toriplimab in patients with locally advanced or metastatic TNBC Secondary Objectives: To characterize the pharmacokinetics (PK) profile of X4P-001 alone or combined with toriplimab To characterize the antitumor activity of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC(according to RECIST 1.1) To characterize the overall survival of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC To characterize the immunogenicity of toriplimab when administrated in combination with X4P-001