Phase I/II Study of Weekly Abraxane and RAD001 in Women with Locally Advanced or Metastatic Breast Cancer. A Study of the Cancer Institute of New Jersey Oncology Group

The purpose of this study is to determine what dose of RAD001and Abraxane is safe to use when the two drugs are used at the same time. Other goals in this study are to learn about the effect of RAD001 and Abraxane on tumor growth; to find out what amount of RAD001 is present in the blood when it is combined with Abraxane; and to learn more about certain genes that produce proteins that may help predict or show an effect (a response to treatment) of this drug combination. Phase I: To determine the maximum tolerated dose (MTD) of RAD001 in combination of weekly Abraxane and determine the Phase II dose of RAD001.Phase II: To determine the activity on tumors, of the combination of RAD001 and Abraxane at the Phase II dose in patients with advanced breast cancer.
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NCI/CTEP 8282: A Phase 1 Study of Chronically-Dosed, Single-Agent ABT-888 in Patients with Either BRCA 1/2 Mutated Cancer; Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer; or Basal-Like Breast Cancer

The main goal of this research study is to find out the highest and safest dose of the study drug, ABT-888, that can be given on a daily basis to subjects with the following cancers: a cancer with a BRCA 1 or 2 (breast cancer 1 or 2 gene) associated cancer (most often breast and ovarian, but may include prostate and pancreatic); ovarian, fallopian tube, or primary peritoneal cancer that returns within 6 months after responding to a platinum-based chemotherapy, or breast cancer that does not express estrogen receptor, progesterone receptor, or human epidermal growth factor receptor (referred to as triple-negative breast cancer). This study will test different dosages of ABT-888. The study uses a well-established process of slowly increasing drug dosage to determine the highest dosage that can be given without causing serious side effects. Other purposes of this research study will be to examine what side effects occur when the drug is given to subjects, how much ABT-888 is in the blood at specific times after it is received, and whether or not ABT-888 is effective in treating these specific types of cancer.
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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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NCI/CTEP 8457: A Randomized Phase II Study of Fulvestrant vs. Fulvestrant in Combination with Bortezomib in Women with ER Positive Metastatic Breast Cancer

Primary: To determine if addition of bortezomib to fulvestrant improves median PFS compared with fulvestrant alone in postmenopausal women with ER-positive locally advanced inoperable or metastatic breast cancer who have disease that is resistant to aromatase inhibitor therapy
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The BEACON Study (BREAST CANCER OUTCOMES WITH NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 vs Treatment of Physician's Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane and Capecitabine

Primary objective:
* To compare overall survival (OS) of patients who receive NKTR-102
given once every 21 days (q21d) to patients who receive Treatment of
Physician's Choice (TPC) selected from the following list of seven singleagent
intravenous (IV) therapies: eribulin, ixabepilone, vinorelbine,
gemcitabine, paclitaxel, docetaxel or nab-paclitaxel
Secondary Objectives:
* To compare the objective response rate (ORR) per Response Evaluation
Criteria in Solid Tumors (RECIST) version 1.1 (hereafter referred to as
RECIST)
* To compare progression-free survival (PFS)
* To compare the clinical benefit rate (CBR, the proportion of patients
having complete response (CR), partial response (PR), or stable disease
(SD) for at least 6 months)
* To compare duration of response (DoR)
* To determine the safety profiles of NKTR-102 and TPC (including Grade
3 and higher toxicities, incidence of dose reductions and dose intensity)
* To compare health-related Quality of Life (HRQoL), using the QLQ-C30
questionnaire with the BR23 subscale
* To obtain pharmacokinetic (PK) data (in selected patients randomized to
NKTR-102 only)
* To evaluate the pharmacoeconomic implications of NKTR-102 therapy
using selected measures of health care utilization
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NSABP FB-9: A Phase II Randomized Clinical Trial Evaluating Neoadjuvant NSABP Chemotherapy Regimens with Weekly Paclitaxel or Eribulin Followed by Doxorubicin and Cyclophosphamide in Women with Locally Advanced HER2-Negative Breast Cancer

Primary objective:To determine the pathologic complete response rate in breast and axillary lymph nodes for patients with HER2-negative locally advanced breast cancer following neoadjuvant therapy
Secondary objectives: Determine 2 year recurrence free-interval.
Determine 2-year overall survival. Determine toxicities of the regimen
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M13-695: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Oral Bioavailability of Veliparib Extended Release Formulations in Subjects with Solid Tumors

Assess and compare the bioavailability of three test extended release (ER) formulations of veliparib with that of the current imemdiate release formulation of veliparib. Evaluate the potential effect of food on the oral bioavailability of three test extended release (ER) formulations of veliparib. Establish the maximum tolerated dose (MTD) and to establish the recommended Phase 2 dose (RPTD) and schedule for one or more of the ER formulations. Secondary objectives of the study are to assess the safety and tolerability of the ER formulations.
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Safety and Feasibility of Short-course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women with Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catherer: A Phase II Trial

To determine whether the short course accelerated partial breast brachytherapy treatment schedules result in local control that is comparable to conventional fractionation schemes for APBI (10 fractions delivered bid over 5 days).
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RTOG 1014: A Phase II study of repeat breast preserving surgery and 3D conformal partial breast re-irradiation (PBri) for local recurrence of breast cancer

The purpose of this study is to evaluate the tumor control and side effects of partial breast re-irradiation given after a lumpectomy. Patients who have had a lumpectomy and are eligible for this trial will receive highly conformal three dimensional conformal radiation therapy (3D-CRT) to treat only the area in the breast where the lumpectomy was performed. 3D-CRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer and to areas that the study doctor thinks may have cancer cells.
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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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LFA102: CLFA102X2102: A phase I, multicenter, open-label study of LFA102 administered intravenously in patients with prolactin receptor-positive castration-resistant prostate cancer or prolactin receptor-positive metastatic breast cancer

Primary objectives
Dose Escalation:
1. To determine the MTD or RP2D of LFA102 as a single agent when administered I.V. to adult patients with prolactin receptor-positive castration
resistant prostate cancer (CRPC) or metastatic breast cancer (MBC)
Dose Expansion:
1. To characterize the safety and tolerability of LFA102, including both acute and chronic toxicities
Secondary objectives
1. To characterize single and multiple dose PK of LFA102
2. Prostate cancer: To assess preliminary anti-tumor activity of
LFA102 as a single agent when administered IV to adult patients with prolactin receptor-positive CRPC
3.Breast cancer: To assess preliminary anti-tumor activity of LFA102 as a single agent when administered I.V to adult patients with PRLR-positive MBC
4. To assess any emergence of anti-LFA102 antibodies
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SWOG S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less

Primary Obj. - to determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, HER2-negative brest cancer with RS < or equal to 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemo compared to no chemo depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemo or not.
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NSABP FB-7: A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens with Weekly Paclitaxel plus Neratinib or Trastuzumab or Neratinib andor Trastuzumab Followed by Doxorubicin and Cyclophosphamide with Postoperative Trastuzumab in Women with Locally Advanced HER2-Positive Breast Cancer

Primary aim and endpoint
Aim: To determine the pathologic complete response rate in breast and axillary lymph nodes(pCR breast and nodes) for patients with HER2-positive LABC following neoadjuvant therapy which consists of paclitaxel/trastuzumab followed by AC VS paclitaxel/neratinib followed by AC
Endpoint: pCR breast and nodes
Secondary aims and endpoints
3.2.1 Pathologic complete response in breast (pCR breast)
Aim: To determine the pCR rate in breast in patients with LABC
Endpoint: pCR breast
3.2.2 Clinical complete response (cCR)
Aim: To determine the cCR rate in patients with LABC who present with palpable
disease
Endpoint: cCR assessed by physical exam at the completion of paclitaxel (before AC)
Endpoint: cCR assessed by physical exam at the completion of AC (before surgery)
3.2.3 Recurrence-free interval (RFI)
Aim: To determine 2-year RFI
Endpoint: Events for analysis of RFI include inoperable progressive disease and local,
regional, and distant recurrence during the 2 years from randomization.
3.2.4 Overall survival (OS)
Aim: To determine 2-year OS
Endpoint: Time from randomization until death from any cause
Toxicity
Aim: To determine toxicities of the FB-7 regimens
Endpoint: Reported toxicities, including cardiotoxicity, as defined by CTCAE v3.0
3.2.6 Correlative science studies
Aim: To explore molecular and genetic correlates of response
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A Randomized Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

Objectives: The primary objective of the study is to assess the progression-free survival (PFS) of oral
veliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel
compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and
metastatic breast cancer.
The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR),
and objective response rate (ORR) in those subjects treated with veliparib plus TMZ or treated with
veliparib plus carboplatin and paclitaxel versus placebo plus carboplatin and paclitaxel.
The tertiary objectives are to assess Eastern Cooperative Oncology Group (ECOG) performance status
and quality of life (QoL).
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NSABP PROTOCOL B-49:A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-RiskNode-Negative, HER2-Negative Breast Cancer

Primary Aim: Aim: To determine if the docetaxel plus cyclophosphamide regimen is non-inferior to the anthracycline-based chemotherapy regimens in terms of invasive disease-free survival (IDFS) by combining B-49 data with the TAC and TC arms of NSABP B-46-I/USOR 07132 and the data from USOR 06-090.
Endpoint: IDFS, defined as time to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.
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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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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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THE WOMEN'S CIRCLE OF HEALTH STUDY

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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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Life After Cancer: Examining Survivor Transitions from Specialist to Primary Care. A study of The Cancer Institute of New Jersey Oncology Group (CINJOG)

Aim 1: Explore the role of primary care providers in breast and prostate cancer survivors' cancer follow-up care.
Aim 2: Develop, test and validate a survey instrument for use among various survivor populations that assesses and measures survivor primary care use and attitudes regarding their follow-up cancer care.
Aim 3: Describe primary care usage of breast and prostate cancer survivors for follow-up care and recurrence surveillance.
Aim 4: Assess cognitive-affective, patient support and demographic factors that affect how survivors use specialists and primary care physicians for follow-up care.
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