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|Protocol||Trial Name and Objective|
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).
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.
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.
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.
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
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
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)
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:
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:
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)
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 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
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
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
THE WOMEN'S CIRCLE OF HEALTH STUDY