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ProtocolTrial Name and Objective
041001

Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women with Breast Cancer: A Phase II Trial

This study is a non-randomized, single arm study of female patients with invasive carcinoma of the breast who have had (or will have) a mastectomy followed by radiation therapy. The term 'accelerated' means that a higher radiation dose per treatment will be delivered over a shorter period of time (compared to the standard). Prior studies suggest that the accelerated radiation scheme used in this study is comparable to the standard or conventional whole breast radiation. That is, the evidence points to accelerated treatments may work at least as well as the longer, standard treatments. Along with measuring the recurrence outcomes, we will be measuring treatment side effects and cosmesis (how well the study treatment plan preserves the appearance of your surgically reconstructed breast).
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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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040406

Effect of DNA Variations on Breast Cancer Risk and Recurrence. A Study of The Cancer Institute of New Jersey Oncology Group (CINJOG)

The purpose of this study is to collect, store and analyze deoxyribonucleic acid (DNA) from patients. Your genes are inherited from your parents and they are in part responsible for why you are different from other people. These slight differences in genes among people are called polymorphisms. By collecting DNA from patients with cancer and without, scientists will be able to study whether these polymorphisms are important in determining the occurrence of cancer and how patients respond to cancer treatments. For example, having a particular polymorphism in a gene may affect the type of side effects you may have from certain drugs during treatment compared to a person who does not have this polymorphism.
Recently several SNPs in particular genes have been identified that may play a role in the earlier development of breast cancer. We want to determine if these SNPs are seen more often in patients with breast cancer as compared with patients of the same age without a diagnosis of breast cancer. We also want to determine if these SNPs are seen more often in patients experiencing a breast cancer recurrence than those remaining cancer-free.
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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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040703

Significance of Single Nucleotide Polymorphisms in Breast Cancer Patients Undergoing Radiation Therapy

In a cohort of approximately 250 women, diagnosed with breast cancer and treated with breast conserving surgery or mastectomy and radiation we will evaluate the frequency of this polymorphism (SNP309). We will correlate the polymorphism status with other clinical, pathologic and genetic information we have on these 250 women, including but not limited to stage, age of onset of disease, receptor status, her2 status, and the status of BRCA1 and BRCA2. We will recruit additional patients with a new diagnosis of breast cancer to correlate the status of SNP309 with other clinical and pathological variables.
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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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041317

CLEE011A2301: A randomized double-blind, placebo-controlled study of LEE011 in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease

To compare progression free survival between LEE011 in
combination with letrozole to placebo with letrozole among
postmenopausal women with HR+, HER2-negative advanced breast
cancer who received no prior therapy for advanced disease using RECIST
1.1
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051101

Phase I Study of Pazopanib in Combination with Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients with Advanced Solid Tumors

1.1 Primary Objective(s)
1.1.1 Determine the safety and tolerability of pazopanib in combination with weekly paclitaxel and weekly carboplatin on Days 1, 8, and 15 every 28 days in patients with advanced solid tumors.
1.1.2 Determine the maximum tolerated dose (MTD) of pazopanib in combination with weekly paclitaxel and weekly carboplatin on Days 1, 8, and 15 every 28 days in patients with advanced solid tumors.
1.1.3 Determine the effect of pazopanib on the pharmacokinetics of paclitaxel and carboplatin.
1.2 Secondary Objective(s)
1.2.1 Assess the clinical activity of pazopanib in combination with paclitaxel and carboplatin administered weekly in patients with solid tumors and in a cohort of triple-negative breast cancer patients.
1.2.2 Evaluate the change in circulating tumor cells in peripheral blood serially in patients enrolled in the dose expansion.
1.2.3 Evaluate blood-based biomarkers, such as cytokines and angiogenic factors (CAF) as potential markers for biological activity, therapeutic sensitivity, or resistance, in patients enrolled in the dose expansion.
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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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041309

REP0210: A single arm, preoperative, pilot study to evaluate the safety and biological effects of orally administered reparixin in early breast cancer patients who are candidates for surgery

1) Evaluate the effects of orally administered reparixin on CSCs in the primary tumor andthe tumoral microenvironment:
A) CSCs will be measured in tissue samples by the following techniques: assessment of CD44/CD24 by flow cytometry or RT-PCR, ALDEFLUOR assay flow cytometry (or ALDH1 by RT-PCR) and by assessment of ALDH1, CD44/CD24 and epithelialmesenchymal markers (Snail, Twist, notch) by immunohistochemistry (IHC). CSCs will be defined as ALDEFLUOR positive (ALDH-1+) and/or CD44 high/CD24 low by flow cytometry or RT-PCR, with consistent results in IHC assays and by the detection of ALDH-1+ cells with or without epithelial-mesenchymal transition (EMT) transcription factor in IHC assays.
B) AKT, FAK, PTEN and CXCR1 levels will be measured in tissue samples by IHC.
C).Measure markers of inflammation (IL-1â, IL-6, IL-8, TNF-á, GM-CSF VEGF, b-
FGF and hsCRP) in plasma, leukocyte subsets (enumerate T (subsets), B, and NK/NKT) and study PMN biology in peripheral blood samples
D) Measure markers of angiogenesis (CD31 staining), autophagy (P62 and LC3 by
IHC), tumor infiltrating leukocytes (CD4, CD8, NK and macrophages), EpCAM and
EMT markers (CD326, CD45, Twist1, SNAIL1, SLUG, ZEB1, FOXC2, TG2, Akt2,
P13k and CK19) and tissue cellularity (residual disease characterization in tumor bed) in surgically resected tumor tissue samples.
2) Evaluate the safety of oral reparixin administered t.i.d. for 21 consecutive days.

Secondary Objective
1) Define the PK profile of orally administered reparixin.
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041311

A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole with or without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women with Hormone Receptor-positive HER2-Negative Breast Cancer

To assess the anti-tumor activity of BYL719 QD plus letrozole and buparlisib QD
plus letrozole versus letrozole alone in increasing the pathologic complete
response (pCR) rate during neo-adjuvant treatment among postmenopausal
patients with HR+, HER2-negative breast cancer for each of the two cohorts: i)
PIK3CA mutated and ii) PIK3CA wild type tumors.
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041312

Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC)

The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed by doxorubicin + cyclophosphamide compared to two neoadjuvant chemotherapy regimens (paclitaxel followed by doxorubicin + cyclophosphamide; carboplatin and paclitaxel followed by doxorubicin + cyclophosphamide) with matching placebo in subjects with triple
negative breast cancer.

The secondary objectives of the study are to assess the incidence of pCR plus minimal residual disease(defined as residual cancer burden [RCB] class I) and the rate of eligibility for breast conservation after
therapy (BCR).
The tertiary objectives are to assess event free survival (EFS), overall survival (OS), clinical response
rate (CRR) at 12 weeks, incidence of chemotherapy-induced peripheral neuropathy (CIPN) as assessed
by the EORTC QLQ-CIPN20 questionnaire and NCI-CTCAE 4.0 grading for peripheral neuropathy,
Eastern Cooperative Oncology Group (ECOG) performance status, and breast cancer related quality of
life (QoL).
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041301

20110148: Randomized, single-blind study to estimate the effect of patient education on reported bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim

To estimate the difference between arms in mean maximum severity of
subject-reported bone pain in cycle 1
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130404

THE WOMEN'S CIRCLE OF HEALTH STUDY


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