|Protocol||Trial Name and Objective|
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.
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).
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.
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
To determine the recommended maximal tolerated dose (MTD) or recommended phase II dose of single agent ONC201 orally once every three weeks
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).
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.
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.
Does Type of Surgical Resection After Neoadjuvant Chemotherapy Affect Breast-Cancer Specific Mortality?
The objective of this study is to investigate whether patients with breast cancer who were downstaged with preoperative chemotherapy to undergo lumpectomy have equal survival to patients who underwent preoperative chemotherapy followed by mastectomy.
Breast Cancer Surveillance in High Risk Patients
The objective of this study is to conduct a retrospective chart review on patients at high risk for developing breast cancer. In particular, we will examine a population who chose to undergo breast surveillance, instead of prophylactic mastectomy, and characterize the nature and extent of their follow-up. We will analyze details such as the number of clinic visits, frequency of screening MRIs and percentage that lead to further work-up including targeted ultrasounds, percutaneous or open biopsies, or surgical intervention. The ultimate aim of this research is to create a framework that can be communicated to high risk patients to help them decide whether to undergo continued surveillance or bilateral prophylactic mastectomy. For those who choose close clinical follow-up, we hope this research will provide a roadmap for what the average patient can expect.
Cardiovascular Morbidity and Mortality after Breast Cancer Treatment
1. Purpose/Specific Objectives
The purpose of the proposed study is to characterize the impact of breast cancer related loco-regional treatment (e.g. surgery (lumpectomy & mastectomy) or radiation therapy) on cardiovascular outcomes and/or cerebrovascular disease in New Jersey.
The overall goal is to study the relationship of breast cancer loco-regional treatment (surgery or radiation therapy) related to cardiovascular and/or cerebrovascular diseases, treatment, environmental and familial factors with respect to long-term outcomes in terms of morbidity and mortality in New Jersey breast cancer patients. Use of procedures, readmissions, death and cause of death are the main outcome measures.
1.1 Primary Endpoint
* To examine the rate of cardiovascular outcomes (Using ICD9 codes 410-414, and 420-429) between breast cancer patients who had radiation therapy for breast cancer (Using ICD9 codes 233, 174, and 175). We will compare left versus right breast cancer patients.
* To examine the rate of cardiovascular outcomes (Using ICD9 codes 410-414, and 420-429) between breast cancer patients (Using ICD9 codes 233, 174, and 175) who did not have radiation therapy for breast cancer.
1.2 Secondary Endpoints
* The differences between sub-groups compared to the reference group (lacking the factor(s) under consideration; i.e. a matched cohort of patients who were not treated for breast cancer) will be investigated by looking at the data longitudinally.
* Future studies may focus on systemic interrelationships between disease incidence, treatment, environmental parameters, etc., and address possible consequences of changes in breast cancer treatment over time on the incidence of cardiovascular and cerebrovascular disease morbidity and mortality after breast cancer treatment.
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.
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)
To assess the safety and tolerability of adjuvant treatment with olaparib
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)
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.
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
The safety objective for this study is as follows:
- To compare cardiac safety and overall safety between the 2 treatment arms
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.
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)
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.
1) Define the PK profile of orally administered reparixin.
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.
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
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
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.
A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab plus Pertuzumab plus a taxane following anthtracyclines vs Trastuzumab Emtansine plus Pertuzumab following Anthracycline as Adjuvant Therapy in Patients with Operable HER2-positive Primary Breast Cancer
The co-primary efficacy objectives for this study are as follows:
To compare invasive disease-free survival in the node positive subpopulation and in the overall protocol-defined population of patients with human epidermal growth (HER) factor-2-positive breast cancer randomized to either receive a taxane and 1 year of trastuzumab plus pertuzumab following anthracycline-based chemotherapy or 1 year of
trastuzumab emtansine plus pertuzumab following anthracycline-based chemotherapy
The secondary efficacy objectives for this study are as follows:To compare IDFS plus second non-breast primary cancers, disease-free survival,
and distance recurrence-free interval in the node-positive subpopulation and
in the overall protocol-defined population between the two treatment arms
To compare overall survival in the node-positve subpopulation and in the
overall protocol-defined population between the two treatment arms
The safety objectives for this study are as follows:
To compare overall safety, cardiac safety, hepatic, and pulmonary safety in the overallprotocol-defined population between the two treatment arms
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
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).
THE WOMEN'S CIRCLE OF HEALTH STUDY
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
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.