Medical Services

Clinical Trials at Englewood Hospital: Oncology

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Breast Cancer

EHMC IRB Study #: E-13-534

Principal Investigator:
Dr. Minaxi Jhawer
Tel: 201-568-5250
Email: jhawerm@gmail.com

Sponsor:
Investigator-Initiated

Study Title:
The Impact of a Community Hospital-Based Yoga Program on the Quality of Life of Women with Triple Negative Breast Cancer

Eligibility requirements:
Patients must be a female, 18 years or older, with ER -, PR -, HER2 - ("triple negative") breast cancer and registered to participate in the free yoga program at EHMC.

Study objectives:
To evaluate the impact of yoga on the quality of life of women with triple negative breast cancer.

Summary of procedures:
Subjects will be asked to complete pre-yoga (Weeks 1, 2, or 3) and post-yoga (Weeks 8, 9, or 10) quality of life questionnaires.

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EHMC IRB Study #: E-13-511

Principal Investigator:
Dr. Jill Morrison
Tel: 201-568-5250
Email: doctorj44@optonline.net

Study Coordinator:
Christine Paolillo, RN
Tel: 201-568-6653
Email: cpaolillo@fsahemonc.com

Sponsor:
Celgene Corporation

Study Title:
A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly nab®-Paclitaxel in Combination with Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First-Line Treatment in Subjects with ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

Eligibility requirements:
Patients must be a female, 18 years or older, with ER (-), PR (-), HER2 (-) metastatic breast cancer.  Patients must have received adjuvant or neo-adjuvant anthracycline therapy - or
anthracycline therapy must be contraindicated.  Patients cannot have received prior cytotoxic
chemotherapy for metastatic breast cancer.  Patients cannot have known brain metastases

Study objectives:
The objective of this trial is to compare the progression-free survival (PFS) of a new chemotherapy called nab-paclitaxel is more effective than existing treatments.  This study will compare the effect of a nab-paclitaxel plus gemcitabine/carboplatin regimen vs. gemcitabine/carboplatin alone in subjects with triple negative metastatic breast cancer


Summary of procedures:
Patients will be randomized 1:1 to either the nab-paclitaxel + gemcitabine/carboplatin vs. gemcitabine/carboplatin alone. Treatments will be given on Days 1 and 8 of a 21-day cycle.  Patients will continue treatment for approximately 1 year orfor as long as the physician thinks it is providing benefit.  Throughout the treatment, patients will have scans to monitor
response to the treatment.  After completion of the treatment, there will be one follow up visit at 28-days post the last treatment, and then patients will be followedevery 3 months for survival.

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EHMC IRB Study #: E-13-506

Principal Investigator:
Dr. Jill Morrison
Tel: 201-568-5250
Email: doctorj44@optonline.net

Study Coordinator:
Audrey Ades
Tel: 201-894-3603
Email: audrey.ades@ehmc.com

Sponsor:
National Cancer Institute - ECOG

Study Title:
E1Z11: A Cohort Study to Evaluate Genetic Predictors for Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)

Eligibility requirements:
Patients must be 18 years or older, post-menopausal, with ER and/or PR positive stage I-III adenocarcinoma of the breast.  The treatment plan for the patient must be to receiveanastrozole for at least 12 months.

Study objectives:
To validate the association between the presence of previously identified genetic information (10 specific markers) and the development of aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) among women with breast cancer.

Summary of procedures:
Patients will take anastrozole as per the physician's regular instruction.  At baseline, the patient will donate a blood sample.  Periodically over 12 months, the patient will complete questionnaires.  If a patient develops AIMSS, then a follow up office visit is required.

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EHMC IRB Study #: E-13-492

Principal Investigator:
Dr. Rosalyn Stahl
Tel: 201-894-3422
Email: rosalyn.stahl@ehmc.com

Study Coordinator:
Neha Kalra
Tel: 201-894-2107
Email: neha.kalra@ehmc.com

Sponsor:
Spectrosense

Study Title:
Testing Spectrosense EVA System for Detection of Breast Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air 

Eligibility requirements:
This study is open to two patient populations: (1) Women with no previous diagnosis of breast cancer.  (2) Women with a biopsy-proven diagnosis of breast cancer who have notyet received any treatment.

Study objectives:
The purpose of this Study is to test the EVA device to see if it can find chemical compounds (called volatile organic compounds or VOCs) in exhaled breaths.  This  study is focused on trying to find VOCs which may be associated with breast cancer.  

Summary of procedures:
Patients in both arms of the study will fill out a questionnaire on their health history and will donate  one breath sample.

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EHMC IRB Study #: E-13-478

Principal Investigator:
Dr. Jill Morrison
Tel: 201-568-5250
Email: doctorj44@optonline.net

Study Coordinator:
Audrey Ades
Tel: 201-894-3603
Email: audrey.ades@ehmc.com

Sponsor:
National Cancer Institute - SWOG

Study Title:
S1027: 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 Receptor-Positive and HER2/NEU Negative Breast Cancer

Eligibility requirements:
Patients who are 18 years of age or older with a histologically confirmed diagnosis of invasive breast carcinoma with (+) estrogen and/or progesterone receptor status and negative HER-2 for whom standard adjuvant endocrine therapy is planned.

Patients must not have inflammatory or metastatic breast cancer (Stage IV disease).

Patients must be of high risk by belonging to one of the following groups: (1.) Completed adjuvant chemotherapy and pathologically negative lymph nodes with a tumor measuring more than 2 cm in diameter and an oncotype DX Recurrence Score > 25 or (2.) Completed adjuvant chemotharpy and pathologically 1-3 positive lymph nodes and an oncotype DXRecurrence Score > 25 or (3.) Completed adjuvant chemotherapy and pathologically 4 or more positive
lymph nodes independent of the oncotype DX Recurrence Score or (4.) completion of neoadjuvant chemotherapy and 4 or more positive nodes pathologically determined prior to or after chemotherapy.

Study objectives:
To compare whether the addition of one year of everolimus in addition to standard endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer.

Summary of procedures:
All patients will receive their planned endocrine therapy and will be randomized to also receive either everolimus (2 pills taken once daily) or a matching placebo daily for 54 weeks.

Assessment for disease recurrence will occur every 12 weeks for 55 weeks, then every six months for two years, and then annually there after until recurrence, death, or 10 years after registration.

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EHMC IRB Study #: E-12-473

Principal Investigator:
Dr. Jill Morrison
Tel: 201-568-5250
Email: doctorj44@optonline.net

Study Coordinator:
Audrey Ades
Tel: 201-894-3603
Email: audrey.ades@ehmc.com

Sponsor:
National Cancer Institute - Alliance

Study Title:
Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias

Eligibility requirements:
Females who are at least 18 years old, have a diagnosis of ER and PR positive breast cancer, are receiving anastrozole (1mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days prior to registration, and are experiencing arthralgia (in hands, wrist, knees, or hips).

Study objectives:
To determine whether testosterone will reduce AI-induced arthralgia and associated joint symptoms.

Summary of procedures:
Patients will be randomized to receive either subcutaneous (as a pellet inserted under the skin) testosterone or placebo once every three months for six months. 

First insertion after 1 week baseline and then repeat at 3 months.  Patients will then be observed monthly for 6 months.

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EHMC IRB Study #:
E-11-430

Principal Investigator:
Dr. Jill Morrison
Tel: 201-568-5250
Email: doctorj44@optonline.net

Study Coordinator:
Audrey Ades
Tel: 201-894-3603
Email: audrey.ades@ehmc.com

Sponsor:
National Cancer Institute - Suncoast CCOP

Study Title:
SCUSF 0806: Phase II Placebo-Controlled Study of Lisinopril and Coreg CR to Reduce Cardiotoxicity in Patients with Breast Cancer receiving (Neo)Adjuvant Chemotherapy with Trastuzumab (Herceptin)

Eligibility requirements:
Females who are at least 18 years old, have a diagnosis of HER2 positive breast cancer, and are scheduled to receive neoadjuvant or adjuvant Herceptin (or Herceptin + chemo) therapy.

Study objectives:
To evaluate the effect of lisinopril or Coreg CR, compared to placebo, on Herceptin-induced cardiotoxicity in patients with breast cancer who are receiving adjuvant or neoadjuvant therapy.

Summary of procedures:
Patients will be assigned to one of three treatment arms: Arm I is oral lisinopril once daily, Arm II is oral Coreg once daily, and Arm III is oral placebo once daily.  Study treatment will begin with the first dose of Herceptin and continues for up to 52 weeks or until the end of Herceptin therapy.   In addition to cardiac function, quality of life will also be assessed at several time points throughout the study.  Patients are followed at 3, 6, 9, and 12 months post-treatment.

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EHMC IRB Study #: E-11-417

Principal Investigator:
Dr. Michael Schleider
Tel: 201-568-5250
MSCHLEIDE@aol.com

Study Coordinator:
Audrey Ades
Tel: 201-894-3603
Email: audrey.ades@ehmc.com

Sponsor:
National Cancer Institute - SWOG

Study Title:
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

Eligibility requirements:
Step 1: Patients with a confirmed diagnosis of node positive invasive breast cancer that is hormone receptor positive and HER-2 negative, and who are post-surgery with negative margins. Step 2: Females who are at least 18 years old with a Recurrence Score < 25 (as determined in Step 1), and who have not yet received any prior therapy.

Study objectives:
To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX.

Summary of procedures:
In Step 1, all patients submit their tumor tissue to Oncotype DX to get a Recurrence Score.  Step 2 is for patients who have a Recurrence Score of < 25 and who have not yet received any treatment. In Step 2, patients will be randomized to 1 of 2 treatment arms: Arm 1 is chemotherapy (3 - 6 cycles) plus endocrine therapy (2 - 5 years), and Arm 2 is endocrine therapy (2 - 5 years) alone. Patients will be followed for recurrence every 3 months for the first year, every 6 months from Years 2 - 5, and then annually.

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*Each listing only contains a summary of the study information. Please contact the Principal Investigator or Study Coordinator for the full details on a particular study.