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ProtocolTrial Name and Objective
041404

TRI-fraction Radiotherapy Utilized to Minimize Patient Hospital Trips : A Phase II trial

To determine the toxicity rate with shorter courses of APBI delivered with a breast brachytherapy applicator.
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041503

The IDEA Study (Individualized Decisions for Endocrine therapy Alone: A prospective, single-arm cohort study of patients receiving endocrine therapy alone (without radiotherapy) after breast conserving surgery for early-stage, post-menopausal breast cancer patients whose tumors have favorable biologic features

2.1 Primary
In a prospective, single-arm cohort study, to evaluate the risk of loco-regional recurrence in postmenopausal women aged 50-69 with biologically favorable, early-stage breast cancer who receive lumpectomy and endocrine therapy alone, without radiotherapy.

2.2 Secondary
2.2.1 To quantify the rate of salvage mastectomy and of other salvage therapy in this setting

2.2.2 To evaluate whether locoregional recurrence is associated with compliance with aromatase inhibitor or tamoxifen therapy over 5 years or duration of endocrine therapy
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041209

The INFORM Study: Randomized Phase II trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide in Women with Newly Diagnosed Breast Cancer and Germline BRCA Mutations

The main goal of this study is to determine if the pathologic complete response (pCR) rate (determined by the Miller-Payne method 1) to neoadjuvant cisplatin is at least 20% greater than the pCR to doxorubicin/ cyclophosphamide (AC) in women with newly diagnosed breast cancer and a germline BRCA mutation.
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041401

A Phase 2 Trial of Liposomal Doxorubicin and Carboplatin in Patients with ER, PR, HER2 Negative Breast Cancer (TNBC)

Primary- Determine the rate of pathologic complete response with treatment of liposomal doxorubicin and carboplatin in patients with ER, PR, HER2 negative breast cancer (TNBC).
Secondary-
1) Determine recurrence free survival (RFS), 2-year RFS, and overall survival (OS) after treatment with neoadjuvant liposomal doxorubicin and carboplatin followed by definitive breast surgery and then weekly paclitaxel in patients with ER, PgR, HER2 negative breast cancer.
2) Describe the mutational spectrum of tumors found in primary, untreated ER, PgR, HER2 negative breast cancer and their association with pathologic complete response to neoadjuvant doxil and carboplatin.
3) Determine functional significance of genomic landscape in predicting drug response using patient derived xenograft (PDX) and ex vivo models.
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051403

A first-in-human phase I single-agent open-label dose-escalation study of every three-week dosing of oral ONC201 in patients with advanced solid tumors

Dose escalation:
To determine the recommended maximal tolerated dose (MTD) or recommended phase II dose of single agent ONC201 orally once every three weeks

Dose expansion:
To characterize the safety and tolerability of ONC201 in patients with tumors that have a high frequency of PI3 kinase pathway or RAS signaling activation (metastatic castrate resistant prostate cancer, metastatic renal cell carcinoma, melanoma, glioblastoma multiforme, breast cancer).
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131404

Virtual Weight Loss Program for African-American Breast Cancer Survivors

Primary objective:
Aim 1: Determine feasibility of using an online commercial weight loss program in AA breast cancer survivors, as measured by:
1. Accrual: % patients recruited and completing baseline assessments.
2. Study retention: % patients completing final follow-up assessment
3. Intervention adherence:
a. Use of website- number of log-ins, time spent, and use of features such as food
diaries, joining teams, posting on message boards, number of SparkPointsTM
received on Sparkpeople.com
b. Use of Fitbit monitor- % patients who wore the monitor and uploaded data
c. Satisfaction (e.g., ease of use of website, usefulness of content, extra training and support needed) and barriers to participation (e.g., lack of computer access, lack of skills, time, interest, etc.)

Hypothesis: Using the online SparkPeople program will be feasible in AA breast cancer survivors(defined as 50% recruitment rate and 85% retention rate).

Secondary Objective
AIM 2: Collect preliminary data on effect sizes of changes in our primary and secondary outcomes
associated with the use of the online commercial weight loss program. Change from
baseline to 3 and 6 months in:
1. Weight, BMI, waist circumference, % body fat (primary)
2. Caloric intake and physical activity levels (secondary)
3. Cardiopulmonary fitness and blood pressure (secondary)
4. Quality of life, fatigue, psychological distress (secondary)
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130503

Environmental Determinants of Puberty. A Pilot Study

To test the feasibility of conducting a cohort study of prepubertal girls in New Jersey and allow us to learn essential information for the planning of such future study.
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131325

Geonotypic and Phenotypic Response of Breast Tissues and Cultured Epithelial Cells from Women Undergoing Reduction Mammoplasty

1.1 Primary Objective(s)

The primary objectives of this study are to examine the association of environmental, lifestyle and behavioral exposures and breast tissue biomarkers, among cancer-free Caucasian and African-American women undergoing elective reduction mammoplasty surgery. This will allow us to gain a better understanding of the determinants of breast tissue biomarkers, which may be associated with breast cancer risk factors.

1.2 Secondary Objective(s)

The secondary objectives of this study will focus on the plasma-breast correlations of select biomarkers related to cell signaling and inflammation/obesity and on the associations between single-nucleotide polymorphisms (SNPs) and plasma and breast tissue biomarker concentrations and protein expression profiles.
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131304

Radiation from Interventional Cardiovascular Procedures and Risk of Breast Cancer

Hypothesis: The primary hypotheses underlying this project are as follows: (1) Exposure to IR delivered during ICPs will lead to an increased risk of developing breast cancer in our cohort of patients and (2) As ICPs have become longer and more complex, the procedural changes over time may increase the relative risk of developing breast cancer.

Aim 1: To quantitate the exposure to IR delivered to patients in New Jersey who underwent interventional cardiovascular procedures.
Aim 1A: To calculate population based rates of low, moderate, high, and very high effective doses of IR from interventional cardiovascular procedures.
Aim 1B: To describe the specific types of interventional cardiovascular procedures among persons for whom the long-term risks of IR exposure are most relevant.

Aim 2: To quantitate the risk of developing breast cancer in patients admitted for cardiovascular disease in New Jersey who had received IR from interventional cardiovascular procedures by linking MIDAS with the NJSCR. We will compare the risk of developing breast cancer in patients exposed to IR (ICP group) and unexposed patients (non-ICP group).
Aim 2A: To link the MIDAS groups from Aim 1 to the NJSCR, and classify cohort members by breast cancer diagnosis.
Aim 2B: To longitudinally compare the IR exposed group with the matched unexposed group of patients who did not receive IR from interventional cardiovascular procedures.
Aim 2C: To estimate the risk of developing breast cancer based on rates of low, moderate, high, and very high effective doses of radiation from interventional cardiovascular procedures.

Aim 3: To determine systemic interrelationships between changes in interventional cardiovascular procedures over time on the incidence of breast cancer and associated rates of morbidity and mortality.
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131310

Role of Body Mass Index and Body Surface Area in Understanding Racial Differences in Chemotherapy Dose Modification for Early Stage Breast Cancer

1)Characterizing racial differences in dose intensity based on BMI and BSA.
2)To examine BMI and BSA as predictors of dose intensity, by race.
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131312

Chronic Disease Outcomes in Older Women with Breast Cancer

The broad aim is to investigate chronic disease outcomes among older women who have been diagnosed with breast cancer.

The specific aims are as follows:
Specific Aim 1. To explore racial differences in the effect of comorbidity on survival time in older breast cancer patients
Specific Aim 2. To evaluate the effect of breast cancer diagnosis on chronic disease medication adherence in older women
Specific Aim 3. To evaluate the effect of breast cancer diagnosis on receipt of preventative health care in older women
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131319

Lifetime Alcohol Exposure and Breast Cancer Risk

This combined case-control study focuses on examining the relationship between alcohol drinking patterns and other factors which may contribute to the etiologies of breast cancer. Major factors to be examined during the course of these investigations included lifetime alcohol consumption patterns, tobacco smoking histories, passive tobacco smoking exposure, diet, occupational history, residential history, medical history, and family history of major diseases
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131320

Environmental and Genetic Determinants of Breast Density in Women

The objectives: to measure breast density in women seeking routine mammography, to compare the association with differences in environmental, lifestyle and behavioral exposures with the level of breast density and to evaluate associations with genetic polymorphisms in candidate genes related to hormone metabolism, among Caucasian and African American women. The analysis focusing on the associations between alcohol intake and breast density will make comparisons between drinkers and non-drinkers of alcoholic beverages, and will examine whethere these associations are mediated by 1) polymorphisms in candidate genes affecting estrogen and alcohol metabolism or 2) menopause status (pre-menopausal vs. post-menopausal).
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041501

NSABP B-55: A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

Primary Objective The primary objective is to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS)
Safety Objective
To assess the safety and tolerability of adjuvant treatment with olaparib
Secondary Objectives
1.To assess the effect of adjuvant treatment with olaparib on overall survival (OS)

2.To assess the effect of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS)
3.To assess the effect of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer
4.To assess the effect of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale
5.To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future germline BRCA mutation assays (gene sequencing and large rearrangement analysis)
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041502

A RANDOMIZED PHASE III TRIAL COMPARING AXILLARY LYMPH NODE DISSECTION TO AXILLARY RADIATION IN BREAST CANCER PATIENTS (cT1-3 N1) WHO HAVE POSITIVE SENTINEL LYMPH NODE DISEASE AFTER NEOADJUVANT CHEMOTHERAPY

Primary objective
To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy.
2.2 Secondary objectives
2.2.1 To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy.
2.2.2 For each treatment arm
* To obtain an estimate of the distribution of residual disease burden scores.
* To estimate the distribution of overall survival.
2.3 Correlative objectives
* To estimate the incidence of arm lymphedema.
* To estimate the incidence of breast lymphedema for patients who underwent breast conserving surgery based on the specific treatment rendered to the axilla.
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041505

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis

In a recent Phase 3 study conducted in women with early stage HER2-positive breast cancer who had previously received adjuvant treatment with trastuzumab, neratinib demonstrated a 33% improvement in disease-free survival versus placebo (hazard ratio = 0.67, which was statistically significant with a p-value of 0.0046). The rationale of this study is to collect safety data in patients with early-stage HER2-positive breast cancer who have completed a prior course of adjuvant trastuzumab in order to expand the safety profile of neratinib when given concomitantly with intensive antidiarrheal prophylaxis for 2 cycles. The results will guide how to better manage neratinib-related diarrhea in this patient population.
The primary objective of this study is to characterize the incidence and severity of diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. The secondary objectives of this study are:
 To evaluate the association between loperamide exposure and incidence and severity of diarrhea.
 To assess incidence of serious adverse events and other adverse events of special interest.
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041506

A Phase II Clinical Trial of Pembrolizumab as Monotherapy for Metastatic Triple -Negative Breast Cancer (mTNBC)

1.Objective (Cohorts A+C): To evaluate the Overall Response Rate (ORR) to pembrolizumab as 2L+ monotherapy in subjects with PD-L1
2.Objective (Cohort A): To evaluate the ORR to pembrolizumab as 2L+ monotherapy for PD-L1 (+) centrally confirmed mTNBC, based on RECIST 1.1 as assessed by central radiology review.
3.Objective (Cohort A): To evaluate the ORR to pembrolizumab as 2L+ monotherapy for centrally confirmed mTNBC independent of PD-L1 status (all comers), based on RECIST 1.1 as assessed by central radiology review.
4.Objective: (Cohorts A-C): To determine the safety and tolerability of pembrolizumab monotherapy for mTNBC. across cohorts and by PD-L1 status within the line of treatment for mTNBC.
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081210

ECOG E2810: Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy

1 .To evaluate disease-free survival with pazopanib as compared to placebo, defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause for patients with metastatic RCC with no evidence of disease following metastatectomy.
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041303

Roche BO27938 / NSABP B-50-I / GBG 77 - A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine versus Trastuzumab as Adjuvant Therapy for Patients with HER2-Positive Primary Breast Cancer who have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

The primary efficacy objective for this study is as follows:
- To compare invasive disease-free survival (IDFS) in patients with residual invasive breast cancer after treatment with preoperative chemotherapy and HER2-directed therapy including trastuzumab followed by surgery between the 2 treatment arms
The secondary efficacy objective for this study is as follows:
- To compare IDFS including second non-breast cancers, disease-free survival (DFS), overall survival (OS), and distant recurrence-free interval (DRFI) between the 2 treatment arms
Safety Objectives
The safety objective for this study is as follows:
- To compare cardiac safety and overall safety between the 2 treatment arms
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041304

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients with Her2+ Metastatic Breast Cancer Who Have Received Two or More Prior Her2-Directed Regimens in the Metastatic Setting

The co-primary objectives of this study are:
1) to compare independently adjudicated PFS following treatment with neratinib plus capecitabine versus lapatinib plus capecitabine in patients with HER2+ MBC who have received two or more prior HER2-directed regimens in the metastatic setting.
2) to compare OS following treatment with neratinib plus capecitabine versus lapatinib plus capecitabine in this population.
3.2 Secondary Objectives
The secondary objectives of this study are to compare between the two treatment groups:Investigator-assessed PFS, Objective response rate (ORR), duration of response (DOR) and clinical benefit rate (CBR)
(complete response [CR] or partial response [PR] or stable disease [SD] ?24 weeks), time to intervention for symptomatic metastatic central nervous system (CNS) disease, safety (AEs, serious adverse events [SAEs]), health outcomes assessments.
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051302

JNJ-42756493: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced or Refractory Solid Tumors or Lymphoma

1) To determine a safe and biologically active Phase 2 dose (recommended Phase 2 dose [RP2D]) for JNJ-42756493 (Part 1 Dose Escalation)
2) To evaluate the feasibility of treating a molecularly-defined subset of subjects with squamous celllung cancer and subjects with breast cancer with JNJ-42756493 at the RP2D (Part 2 Dose Expansion)
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041314

S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer

1.1 Primary Objective

The primary objective of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer.

1.2 Secondary Objectives

a. To compare whether the addition of one year of everolimus to standard adjuvant endocrine therapy improves overall survival (OS) and distant recurrence-free survival (DRFS) in this patient population.

b. To evaluate the safety, toxicities and tolerability of one year of everolimus in combination with standard adjuvant endocrine therapy and compare it with standard adjuvant endocrine therapy plus placebo in this patient population.

c. To determine whether the benefit of one year of everolimus use in addition to standard adjuvant endocrine therapy varies by recurrence score (RS), nodal status, or other commonly used prognostic factors.

d. To evaluate adherence to 1-year treatment of everolimus in comparison to placebo in addition to standard adjuvant endocrine therapy in this patient population.
e. To collect specimens in order to evaluate biomarkers of therapeutic efficacy.
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051304

Phase IB Study of MK-3475 in Subjects with Select Advanced Solid Tumors

To evaluate preliminary signals of potential anti-tumor activity of MK-3475
in subjects with a given a histopathologic type of PD-L1 positive advanced solid tumor based on RECIST 1.1 as determined by the investigator in specific tumor indications
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041403

A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a
BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or Locally Advanced Unresectable
Breast Cancer.
The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR),
objective response rate (ORR), PFS2 and duration of overall response (DOR) in subjects treated with
veliparib in combination with C/P versus subjects treated with placebo with C/P. The tertiary objectives
are to assess change in ECOG performance status, change in Quality of Life (QoL).
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130404

THE WOMEN'S CIRCLE OF HEALTH STUDY


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131039

Non Clinical Factors in Disparate Treatment for Early Stage Breast Cancer among Blacks and Whites

1. To examine patient- and health system-level factors that may contribute to disparities in receipt of initial adjuvant chemotherapy among patients diagnosed with early stage breast cancer.
2. To examine care process-level factors that may contribute to disparities in receipt of initial adjuvant chemotherapy among patients diagnosed with early stage breast cancer.
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041306

Chemotherapy effect on brain structure, neurophysiology and psychomotor behavior in breast cancer patients

All testing and data collection will take place by staff at Kessler Foundation Research Center. Dr. Serena Wong at CINJ will be involved only in the recruitment and screening of study subjects and interpretation of results.

Objectives of study:
1. To evaluate the effects of chemotherapy on the integrity of the corpus callosum and corticospinal tract using magnetic resonance diffusion tensor imaging.
2. To characterize neurophysiological function and psychomotor behavior which are critically dependent on the integrity of the CC and CST
3. To investigate the relationship among white matter structure damage, neurophysiological function and psychomotor behavior changes
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041308

NSABP B-51: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT

To evaluate whether the addition of regional nodal radiation to chestwall and/or breast radiation will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

PRIMARY AIMS: Ipsilateral recurrence-free interval, defined as time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer.

SECONDARY AIMS: Overall and disease-free survival, characterization of locoregional recurrence patterns, second invasive and/or in situ cancers, QOL, molecular marker predictors, effectiveness of adjuvant radiation techniques.
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