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|Protocol||Trial Name and Objective|
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.
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).
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)
NSABP FB-7: A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens with Weekly Paclitaxel plus Neratinib or Trastuzumab or Neratinib and Trastuzumab Followed by Doxorubicin and Cyclophosphamide with Postoperative Trastuzumab in Women with Locally Advanced HER2-Positive Breast Cancer
Primary aim and endpoint
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
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.
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
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.
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.
TAC113886: A Phase I Dose Escalation Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study to Determine the Recommended Phase II Dose of GSK1120212 Dosed in Combination with GSK2141795
Primary: Part 1A: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination orally, once daily continuously. Part 1B: To determine the safety, tolerability and recommended Phase II dose of GSK1120212 and GSK2141795 administered in combination with an alternate schedule (i.e., at least one agent is dosed intermittently). Part 2A, 2B: To evaluate the clinical activity of GSK1120212 and GSK2141795 administered in combination in subjects with solid tumors that are predicted to be sensitive to the inhibition of MEK and/or AKT, including TNBC and BRAF-wild type melanoma.
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:
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.
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.
THE WOMEN'S CIRCLE OF HEALTH STUDY