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NCT ID: NCT03769415 Recruiting - Breast Cancer Clinical Trials

Harnessing Analysis RNA Expression and Molecular Subtype to Optimize Novel TherapY MBCA

HARMONY
Start date: November 6, 2018
Phase: N/A
Study type: Interventional

The HARMONY trial is an interventional trial designed to determine the impact of molecular information on clinical decision-making in metastatic breast cancer (MBC). HARMONY will enroll incident MBC patients. We will perform intrinsic subtype on the primary tumor using the PAM50 methodology in a CLIA-compliant setting and provide these data to the treating physician. In this way we will identify the congruence rates between expected and observed subtype based on clinical phenotype (e.g. luminal biology in a hormone receptor-positive tumor), survey the treating physicians regarding the impact of this biologic information on treatment decisions, and examine progression-free survival on concordant vs discordant treatment regimens. We will also examine other gene expression signatures related to tumor behavior and immune activation including signatures developed to characterize tumor-immune interaction and will perform RNA sequencing, however the results of those assays will be analyzed in an integrated fashion and will not be provided to the treating physician.

NCT ID: NCT03761706 Recruiting - Breast Cancer Clinical Trials

Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging

Start date: February 28, 2018
Phase: N/A
Study type: Interventional

Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. Participants: 100 patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy. Procedures: The study entails screening, recruiting and consenting 100 eligible breast cancer patients who are about to begin adjuvant or neoadjuvant chemotherapy and agree to participate in a physical activity intervention, maintain a printed daily exercise log, wear a FitBit, complete questionnaires and assessments, and provide blood samples at various time points.

NCT ID: NCT03760536 Recruiting - Breast Cancer Clinical Trials

Get REAL and HEEL Research Program

Start date: March 20, 2017
Phase:
Study type: Observational [Patient Registry]

The UNC Get REAL & HEEL (GR&H) program has provided after treatment support for women with a breast cancer diagnosis since 2006. The 16-week program includes an individualized training program and the opportunity to continue working out in the GR&H facilities at the conclusion of the 16-week program. The purpose of this protocol is to implement a research agenda at GR&H that will examine the efficacy of the program. The primary aim of this study is a pre-post test of the impact of the GR&H program (standardized combination of aerobic and resistance training) on VO2peak1,2. The secondary aims of this study are to evaluate quality of life as well as cardiorespiratory function (vascular health), physical function (muscular strength, body composition), cognition, balance, and patient-reported outcomes (fatigue, depression, anxiety, quality of life). Exploratory aims are focused on evaluating the impact of exercise on biomarkers: (1) aging - p16INK4a, (2) immune cell function - total leukocyte count, T and natural killer cells, monocytes, and neutrophils count and activity, and (3) circulating pro- and anti-inflammatory cytokines.

NCT ID: NCT03759548 Recruiting - Breast Cancer Clinical Trials

Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer

Start date: November 1, 2018
Phase:
Study type: Observational

Cancer patients undergo many different modalities of treatments. Pharmacological treatment should be well understood. The nutritional status is not taken into account when calculating drug's doses and this may have an impact in toxicity and quality of life. The present study proposes to evaluate the relationship between the calculation of pharmacological treatment's doses, the toxicity and the impact on quality of life among colorectal and breast cancer's patients.

NCT ID: NCT03750396 Recruiting - Breast Cancer Clinical Trials

Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer

CLEAR
Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.

NCT ID: NCT03750240 Recruiting - Breast Cancer Clinical Trials

Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy

Start date: July 25, 2017
Phase: N/A
Study type: Interventional

Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI. This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).

NCT ID: NCT03744715 Recruiting - Breast Cancer Clinical Trials

A Study to Allow Continued Treatment of Patients Who Have Participated in a Spectrum-Sponsored Poziotinib Study

Start date: October 5, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label extension study (Extension Study) designed to allow patients to continue to receive poziotinib treatment after they have completed the duration of treatment and all protocol-specified assessments and procedures in a previous Spectrum-sponsored poziotinib study (Original Study). Patients will proceed to the study with a maximum hiatus of 20 days following the End-of-Treatment (EOT) visit in the Original Study. This extension protocol is intended to provide clinical benefit of poziotinib to patients who are responding to treatment. The additional treatment is optional and voluntary.

NCT ID: NCT03740503 Recruiting - Breast Cancer Clinical Trials

Genomic Investigation of Unusual Responders

GENIUS
Start date: November 1, 2013
Phase:
Study type: Observational

Studies have shown that tumors from the same patient may respond very differently to the same therapeutic agents. This study aims to investigate the genetic basis of tumors that respond abnormally well or poorly to therapeutic agents in an effort to understand the fundamental genetic basis of this response. The present protocol seeks to retrospectively perform Exome, next-generation (DNA) sequencing and/or other molecular techniques on tumor samples to identify the genetic basis of a patient's exceptional response to chemotherapy.

NCT ID: NCT03738605 Recruiting - Breast Cancer Clinical Trials

Vaginal Laser Therapy in Breast Cancer Survivors

Start date: November 25, 2018
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.

NCT ID: NCT03737500 Recruiting - Breast Cancer Clinical Trials

Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer

BLITE-01
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.