|
 Medical Services
Clinical Trials at Englewood Hospital: Oncology
Breast Cancer
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.
###
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.
###
EHMC IRB Study #: E-12-453
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 Adjuvant Surgical Breast and Bowel Project (NSABP)
Study Title:
NSABP 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-Risk Node-Negative HER2-Negative Breast Cancer
Eligibility requirements:
Females who are at least 18 years old, have a diagnosis of HER2 negative breast cancer, mastectomy or lumpectomy performed within 84 days of study entry, and have received no previous chemotherapy
Study objectives:
To determine if Docetaxel + Cyclophosphamide is non-inferior to an anthracycline-based chemotherapy regimen in terms of invasive disease-free survival. The toxicities of both regimens will also be compared.
Summary of procedures:
Patients will be assigned to one of two treatment arms: Arm 1 will receive one of four anthracycline-based chemotherapy regimens (physician's choice). Arm 2 will receive 6 cycles of docetaxel + cyclophosphamide administered every 21 days. Patients will also receive adjuvant radiation therapy as clinically indicated and endocrine therapy for hormone receptor-positive tumors
Patients will be followed every six months after the completion of their assigned chemotherapy until Year 6. The patients will then be followed every 12 months through Year 10.
###
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.
###
EHMC IRB Study #: E-11-411
Principal Investigator:
Dr. David Dubin
Tel: 201-541-2463
Email: david.dubin@ehmc.com
Study Coordinator:
Audrey Ades
Tel: 201-894-3603
Email: audrey.ades@ehmc.com
Sponsor:
NSABP
Study Title:
NSABP B-39: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer
Eligibility requirements:
Females who are at least 18 years old with Stage 0, 1 or 2 breast cancer, who have had a prior lumpectomy with negative margins, and who have not yet received any treatment.
Study objectives:
To determine the effectiveness of partial breast irradiation (PBI) compared to whole breast irradiation (WBI) in providing equivalent local tumor control in early stage breast cancer.
Summary of procedures:
Patients will be randomized to receive either PBI or WBI. For the PBI group, if chemotherapy is indicated, the radiation will be given prior to the chemotherapy. For the WBI group, the chemotherapy (if indicated) will be given before the radiation. Patients will be followed with scans and labs at the end of therapy, 4 weeks following therapy, every 6 months through 5 years, then annually thereafter.
###
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.
|
|
