View clinical trials related to Breast Neoplasms.
Filter by:Primary Objective: To evaluate the tumor Objective Response Rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of SAR566658 in participants with anti-carbonic anhydrase 6 (CA6)-positive metastatic triple negative breast cancer (TNBC). Part 1: To select the SAR566658 dose based on ORR and safety of 2 dose levels of SAR566658. Part 2: Part 2a: To demonstrate the activity of SAR566658 based on ORR in participants overexpressing CA6 (membrane intensity of 2+, 3+ in greater than or equal to (>=) 30% of tumor cells) treated at the selected dose in an expanded cohort, in addition to the participants treated in Part 1. - Part 2b: To assess the efficacy in participants with metastatic TNBC and mild CA6 expression. Secondary Objectives: To assess: - Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS), and Time To Progression (TTP). - The impact of ocular primary prophylaxis on the incidence of keratopathies. - The potential immunogenicity of SAR566658. - To evaluate the global safety profile.
The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose of GS-5829 in combination with fulvestrant in women with advanced estrogen receptor positive, HER2-negative (ER+/HER2-) breast cancer. The primary objective of the Randomized Phase 2 Dose Expansion portion of this study is to evaluate the efficacy of GS-5829 in combination with fulvestrant compared to fulvestrant alone in women with advanced ER+/HER2- breast cancer. This study was terminated early and the Phase 2 portion of the study was not conducted.
The purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.
This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer. The study is an open-label design, consists of 2 parts: dose-finding portion (Part 1), and expansion portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 102 patients will be enrolled in the study.
In this four-part study, NKTR-214 was administered in combination with nivolumab and with/without other anticancer therapies. Part 1 considered escalating doublet (NKTR 214 + nivolumab) doses to determine the RP2D. Part 2 considered dose expansion cohorts for the doublet (NKTR 214 + nivolumab ± chemotherapy). Part 3 was schedule-finding for a triplet therapy (NKTR 214 + nivolumab + ipilimumab). Part 4 dose expansion for the triplet (NKTR 214 + nivolumab + ipilimumab) was planned to further assess the efficacy of the RP2D triplet combination at dosing schedules from Part 3.
The purpose of this study is to evaluate the effect of two exercise programs: 1) one program will be at low intensity; 2) the other program will be at moderate intensity. One hundred forty two women who are breast cancer survivors will be recruited. Participants will be educated on a home exercise program to be performed at either low or moderate intensity, according to group assignment. Evaluations to participants will consist of function and quality of life.
Art Therapy is a health profession in which art making is utilized as a means of expression and communication within a therapeutic and supportive relationship [1]. Art therapy has been shown to reduce psychological (anxiety, negative mood) and physical (pain, fatigue) symptoms which accompany many breast cancer patients and survivors [2-7]. Qualitative studies provide an initial understanding of the mechanisms through which art therapy facilitates symptom reduction [8]. Breast cancer patients have reported that art therapy provided them with access to emotional material otherwise inaccessible [9]. The goal of this study is to examine the effect of art making within a therapeutic framework on emotional awareness and acceptance.
This study is designed to compare the effectiveness of intradermal injection and subcutaneous injection with methylene blue for early-stage breast cancer patients who need sentinel lymph node biopsy.
Breast cancer related lymphedema (BRCL) is a common complication following breast cancer treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities, impaired physical mobility, mental discomfort, reduced quality of life and erysipelas. Therapy of BRCL is divided into conservative and operative methods. However, all the above method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety of this method will be also assessed.
Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced melanoma or metastatic TNBC Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune systems in those subjects who have failed 1st line therapy The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12 subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC) subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting dose is 4 mg/kg for Imprime PGG. In the event there are a total of > 4 (or > 33%) of subjects with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced to 2 mg/kg, and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of n=12 subjects. For the dose that meets the safety criterion in Stage 1, at least 1 response in melanoma subjects and 2 responses in TNBC subjects amongst the 12 subjects within each tumor type must be observed in order to proceed to Stage 2. Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For the dose that meets the Stage 1 safety criterion, success will be declared if at least 4 amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42 subjects with TNBC achieve an objective response.