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Breast Cancer clinical trials

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NCT ID: NCT02992730 Active, not recruiting - Clinical trials for Breast Cancer Female

Predictors of Adjuvant Endocrine Therapy in Women With Breast Cancer

WHIP
Start date: April 2011
Phase:
Study type: Observational

Breast cancer is the leading cancer diagnosed in women and the second cause of cancer death. Of all racial/ethnic groups in the US, Black women have the highest rate of breast cancer deaths. Two-thirds of Black breast cancer patients have estrogen receptor (ER) positive tumors that can be treated with adjuvant hormonal therapy. If taken for the full five years, this therapy has been shown to reduce mortality by 50%. However, ER positive Black women are more likely to die from their breast cancer as ER positive White women. Preliminary data suggest that non-adherence to adjuvant hormonal therapy could explain some of this disparity. To date, no study has systematically examined psychosocial, healthcare, and biological factors that predict adherence to hormonal therapy in Black women with breast cancer. To begin to fill this knowledge gap, Investigators will conduct a prospective cohort study of 422 ER positive Black breast cancer patients recruited from health maintenance organizations (HMOs). Our primary outcome is adherence to therapy at 36 months post initiation. Specific aims are to: 1) Examine psychosocial factors (e.g. health beliefs, socio-cultural values, etc.) that predict adherence to hormonal therapy; 2) Identify clinical (e.g., side effects), and biological (e.g., stage, etc.) factors that predict adherence to hormonal therapy; and 3) Evaluate healthcare variables (e.g., communication, management of side effects, etc.) that predict adherence. Investigators will also explore the role of CYP2D6 genetic variations in adherence to hormonal therapy which is novel and will increase knowledge about this genetic factor in Blacks. The study is focused on the time-period (first 3 years) when women appear to be the most vulnerable to terminating treatment prematurely. A better understanding of predictors of adherence in Black women may help target interventions and ultimately improve potentially avoidable adverse breast cancer outcomes in this underserved group.

NCT ID: NCT02983071 Active, not recruiting - Breast Cancer Clinical Trials

G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT02980848 Active, not recruiting - Breast Cancer Clinical Trials

Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study

BCSC-ADVANCE
Start date: September 2016
Phase:
Study type: Observational [Patient Registry]

This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational pragmatic comparative effectiveness research study using high-quality, prospectively collected data from BCSC registries to generate evidence on how breast density should be integrated into decision making around breast cancer screening and preoperative diagnostic work-up. We will augment existing BCSC registry infrastructure with additional prospective data collection and collection of patient reported outcomes (PROs), CISNET modeling of long-term screening outcomes, and qualitative data from focus groups with women represented in two aims.

NCT ID: NCT02958774 Active, not recruiting - Breast Cancer Clinical Trials

Hypofractionated Radiation Therapy for Patients With Breast Cancer Receiving Regional Nodal Irradiation

Start date: October 23, 2017
Phase: N/A
Study type: Interventional

The primary objective of this study is to document lymphedema rates in patients requiring regional nodal irradiation (RNI) who receive hypofractionated radiation as compared to conventional radiation.

NCT ID: NCT02955940 Active, not recruiting - Breast Cancer Clinical Trials

An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib

Start date: November 30, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide continued supply of ruxolitinib alone, ruxolitinib plus background cancer therapy, or background cancer therapy alone to subjects from an Incyte-sponsored study of ruxolitinib that has reached its study objectives or has been terminated. This study will also provide another mechanism for reporting adverse events related to study drug safety.

NCT ID: NCT02955394 Active, not recruiting - Breast Cancer Clinical Trials

Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer

Start date: September 21, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment.

NCT ID: NCT02949167 Active, not recruiting - Breast Cancer Clinical Trials

MyHealth: Follow-up After Breast Cancer Treatment

MyHealth
Start date: November 2016
Phase: N/A
Study type: Interventional

Approximately 24,000 women attend a follow-up care program after end of primary treatment for breast cancer (BC) in Denmark. There is no well-conducted, larger randomized controlled trials (RCT) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. The primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program (MyHealth) will significantly reduce reported symptoms among BC patients following primary treatment compared to physician-led scheduled follow-up. Secondary, the investigators will examine patient activation (self-management), anxiety, depression, fear of recurrence, work ability, time to recurrence, overall survival, health behavior changes, health care utilization and financial costs in the two arms. The MyHealth program provides patients with a nurse-led education focusing on management of symptoms, an electronic platform to report symptoms to the nurses and support in symptom management and navigation of patients to appropriate health care services.

NCT ID: NCT02942355 Active, not recruiting - Breast Cancer Clinical Trials

Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer

Start date: December 7, 2016
Phase: Phase 2
Study type: Interventional

This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after first-line chemotherapy in postmenopausal patients with HR-positive, HER2-negative metastatic breast cancer. Pre- and perimenopausal women must receive therapy with an LHRH agonist. The LHRH agonist will be by choice for an approved LHRH agonist administered according to its respective prescribing information. Following informed consent and eligibility check, subjects will be enrolled to either Cohort A or Cohort B.

NCT ID: NCT02938390 Active, not recruiting - Breast Cancer Clinical Trials

Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy

Start date: October 2016
Phase:
Study type: Observational

Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in the study. US will be performed after induction of general anesthesia, prior to surgery using Sonositeā„¢ portable US, 5-12mHz transducer using doppler mode.

NCT ID: NCT02918084 Active, not recruiting - Breast Cancer Clinical Trials

CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer

GIM10-CONSENT
Start date: June 2013
Phase: Phase 3
Study type: Interventional

Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet.