View clinical trials related to Breast Neoplasms.
Filter by:This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study: Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort). Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort). Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.
Worldwide, breast cancer is the most incident and prevalent cancer among women. Despite advances in the treatment of advanced breast cancer (ABC) during the past decade, adjuvant systemic therapy has yield little progression for such patients. ABC remains an incurable disease, responsible for approximate 40,000 deaths annually and a median life expectancy of no more than 3 years. The NCCN guidelines clearly define routine adjuvant chemotherapy regimens for the early breast cancer, however, for the patients with recurrence and metastasis, the choice of treatment options is not clear. In this trial, we choose the patients with disease progression who received anthracycline and taxane adjuvant chemotherapy after surgery. The patients received vinorelbine and gemcitabine (NG) or vinorelbine and platinum (NP) regiments for 6 cycles. Then the patients with complete response (CR), partly response (PR) and stable disease(SD) will be assigned to 3 groups, one group will receive the original regiment for 3 cycles to maintain treatment, one group will receive the vinorelbine for 6 cycles, the other group will receive the capecitabine for 6 cycles. Trasuzumab will be used to patients if HER-2 positive. Endocrine therapy will be used if the hormone receptors positive after the chemotherapy. The primary endpoint is to assess disease-free survival (DFS), the secondary endpoint is to assess the overall survival (OS).
This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).
This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side effects, and oncologic outcomes.
Sacrifice of the intercostobrachial nerve (ICBN) during surgery is associated with development of persistent post-surgical pain (PPSP), which affects up to 60% of breast cancer surgery patients. A large, definitive trial is needed to establish whether nerve preservation techniques are effective in reducing post-surgical pain after breast cancer surgery. If the effect of ICBN preservation is consistent with observational studies, the absolute reduction of rates of persistent pain would be considerable.The primary objective is to determine the effect of ICBN preservation, versus usual care, on the prevalence and intensity of PPSP at one year after breast cancer surgery involving axillary lymph node dissection (ALND). Within the larger INSPIRE pilot, we will also be conducting a biomarker sub-study. The objectives of the biomarker sub-study are: 1) to determine the association between pro-inflammatory cytokine levels and the presence and intensity of persistent pain at 3 weeks, and 3 months post-surgery, and) 2) to determine the effect of study intervention on the change in cytokine levels (pre-operative to post-operative) in participants who consent to participate in the sub-study.
The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.
Breast cancer, the first female cancer, affects one in eight women in her lifetime. The increase and uneven distribution of its prevalence throughout the world cannot be fully explained either by the increase in life expectancy, or by genetic factors present in less than 10% of cases, or by early detection, or by the use of hormone therapy for menopause at certain periods of time. Numerous experimental and epidemiological arguments, as well as the increased risk of breast cancer in women after 50 years of age who were exposed in utero to Distilbene prescribed for their mothers in the 1950s to 75's, suggest the involvement of environmental factors involved in early development (nutrition, alcohol, tobacco, chemical pollutants) that may act as endocrine disruptors, estrogenomimetic or intervening on other nuclear receptors such as the However, the formal demonstration of the deleterious physiopathological role of such exposure comes up against methodological difficulties in epidemiological terms: first of all, the fact that correlation is sought at the time of the discovery of breast cancer when there are critical windows of exposure (fetal, perinatal, peripubertal and pregnant) and that persistent organic products or POPs, most often lipids, are present. The objective of this project is to correlate the per-gravidic exposure to POPs (dioxins, dioxinlike, polychlorinated bisphenyls, organochlorine pesticides and flame-retardant polybrominated derivatives) and the development, within 15 years of delivery, of breast cancer, taking into account the confounding factors of classical breast cancer risk (age, reproductive events, etc.). This project benefits on the one hand from a cord blood bank set up between 2002 and 2005 (6,242 samples) carried out at the Nice University Hospital and the Grasse University Hospital, during a PHRC and on the other hand from the cancer observatory / CRISAP of the PACA Corsica region, exhaustive to more than 92% since 2005, registers which will be cross-referenced and whose cancer cases (N) will be compared to controls. The assays will be carried out after purification, using high-resolution mass spectrometry gas chromatography coupling, the quantification being carried out according to the principle of isotopic dilution. They will be carried out by LABERCA in Nantes, the national reference laboratory of the French Health Agencies ANSES and INVS and also involved in various European projects. Concentrations related to blood lipids will be expressed in quartile and analyzed separately or combined with a cumulative score taking into account confounding risk factors for breast cancer and the geolocation of the initial and final residence in relation to the incinerator of the City of Nice (Department of Public Health CHU of Nice).
This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy.
Breast cancer patients often receive systemic drugs as the initial curative treatment of their disease. The initial systemic therapy leads to a variable degree of tumor shrinkage. At present, there is no evidence-based consensus among breast surgeons on the optimal extent of resection after considerable tumor shrinkage and whether resection margin should be designed according to the tumor extent before treatment or the extent after treatment. This trial will help determine the optimal extent of resection in tumors that exhibits a significant change in volume after primary systemic therapy.
This research study is studying a drug called atezolizumab as a possible treatment HER2-positive metastatic breast cancer (MBC) that has spread to the brain. The names of the study drugs involved in this study are: - Atezolizumab - Pertuzumab - Trastuzumab