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ProtocolTrial Name and Objective
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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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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041508

The Effects of Race and Ethnicity on the Risk of Venous Thromboembolism in Women 65 Years or Older with Breast Cancer

This is a retrospective cohort study to evaluate the risk of VTE in women with breast cancer 65 years and older by race and ethnicity. The linked Surveillance, Epidemiology, and End Results (SEER) and Medicare database will be used for women 65 years and older diagnosed with breast cancer.
Objectives:
* Evaluate trends in incidence of VTE based on race/ethnicity over time.
* Evaluate the effect of race/ethnicity on the incidence of VTE after controlling for stage of disease, treatment modalities, and socioeconomic status.
* Evaluate differences in 5-year and overall survival in patients with VTE based on race/ethnicity
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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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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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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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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:
h To evaluate the association between loperamide exposure and incidence and severity of diarrhea.
h 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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051508

Protocol #: 20140318: A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

The primary objective of the study is to evaluate the maximum tolerated dose (MTD) of intrahepatic injection of talimogene laherparepvec into tumors of the liver, based on subject incidence of dose-limiting toxicities (DLTs), separately in subjects with primary hepatocellular carcinoma (HCC) and subjects with metastatic liver tumors (non-HCC).
The secondary objectives of the study are as follows:
* To evaluate the safety of intrahepatic injection of talimogene laherparepvec into liver
tumors as assessed by subject incidence of treatment-emergent and
treatment-related adverse events
* To evaluate the efficacy of intrahepatic injection of talimogene laherparepvec in the overall population and by tumor type (non-HCC and HCC) as assessed by: objective response rate (ORR), best overall response (BOR), durable response rate (DRR), duration of response (DOR), response in injected and uninjected lesions, disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
* To estimate the incidence of detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in blood and urine
* To estimate the incidence of clearance of talimogene laherparepvec DNA from blood and urine
* To estimate the rate of detection and incidence of talimogene laherparepvec DNA and virus at the surface of talimogene laherparepvec injection site, the exterior of the occlusive dressing, and the oral mucosa
* To estimate the incidence of talimogene laherparepvec DNA detection in lesions
suspected to be herpetic in origin

The exploratory objectives of the study are to assess blood and tumor tissue for potential biomarkers which predict and/or are correlated with clinical outcomes to talimogene laherparepvec
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041510

SOLAR-1: A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment

Primary: To determine whether treatment with alpelisib in combination with fulvestrant prolongs PFS compared to treatment with placebo in combination with fulvestrant for each of the following cohorts i) patients with PIK3CA mutant status ii) patients with PIK3CA non- mutant status
secondary: To determine whether treatment with alpelisib in combination with fulvestrant prolongs overall survival (OS) compared to treatment with placebo in combination with fulvestrant for each of the following cohorts i) patients with PIK3CA mutant status ii) patients with PIK3CA non-mutant status
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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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130404

THE WOMEN'S CIRCLE OF HEALTH STUDY


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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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041406

Use of the BioZorb implant to delineate the tumor excision site following lumpectomy

Objective:
To document findings and outcomes for patients who have the BioZorb surgical tissue marker implanted following partial mastectomy or "lumpectomy" in a broad spectrum of clinical practice settings.
Endpoints:
1. Surgical: identify the surgical sub-groups that physicians choose for implantation of the BioZorb; understand various cavity closure techniques that are used following tumor excision and how these techniques are utilized, and monitor surgical outcomes such as wound healing, cosmetic outcomes and surgeon satisfaction.
2. Radiation Oncology: identify the various types of radiation therapy delivered following lumpectomy, record the planned treatment volumes of tissue treated and document the utility of BioZorb for treatment planning and delivery.
3. Patient Satisfaction: patients rate their overall satisfaction with the breast appearance, patient acceptance, and treatment outcomes
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