J1259: A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment
This research is being done to find out if the investigational drug BKM120 is safe and effective when given with fulvestrant (Faslodex) to postmenopausal women whose hormone receptor-positive beast cancer has progressed on or after aromatase inhibitor treatment.
Website: http://www.clinicaltrial.gov/ct2/show/NCT01610284?term=belle2&rank=1
Principal Investigator:  Jeanine Werner, MD
Research Coordinator:  Liz Egan, RN (443) 481-5811
 

M12-895: 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
This research is being done to determine if patients with BRCA1 or BRCA2 mutation and metastatic breast cancer do better with veliparib in combination with temozolomide or carboplantin and paclitaxel with or without veliparib.
Website:  http://clinicaltrials.gov/ct2/show/NCT01506609?term=veliparib+AND+BRCA&rank=1
Principal Investigator:  Jeanine Werner, MD
Research Coordinator:  Liz Egan, RN (443) 481-5811
 

SBIR: Computed Optical Margin Assessment for Breast Cancer – Phase I
The purpose of this research is to see if a research study device called the Enlighten Imaging system can help surgeons better see the boundary between abnormal and normal breast tissue.
Website:  http://clinicaltrials.gov/ct2/show/NCT01699867?term=breast++cancer+optical+margins+assessment&rank=1
Principal Investigator:  Lorraine Tafra, M.D.
Research Coordinator:  Kristen Sawyer, CCRA  (443)481-5749
 

NSABP B-47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer
The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin®), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning. A second purpose of this study is to learn if adding trastuzumab to treatment with chemotherapy will help women with HER2-low breast cancer live longer.
Website: http://clinicaltrials.gov/ct2/show/NCT01275677?term=BREAST+NSABP+B-47&rank=1
Principal Investigator: Jeanine Werner, M.D.
Research Coordinator:  Liz Egan, RN (443) 481-5811

J1244 CD-ON-MEDI-573-1030: A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in Women with Metastatic Breast Cancer (MBC) �
This research is being done to find out what effects (good or bad) the combination of the investigational drug MEDI-573 and aromatase inhibitors (AIs) has on you and your breast cancer. As part of this study, researchers would also like to do laboratory testing on tissue samples and blood samples to find out as much as possible about breast cancer and how this regimen might affect the disease.
Website: http://clinicaltrials.gov/ct2/show/NCT01446159?term=BREAST+MEDI-573&rank=1
Principal Investigator:  Jeanine Werner, MD
Research Coordinator:  Liz Egan, RN (443) 481-5811

NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
This study will find out if adding trastuzumab to breast radiation therapy is more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-positive DCIS.
Website:  http://clinicaltrials.gov/ct2/show/NCT00769379?term=bREAST+NSABP+B-43&rank=1
Principal Investigator: Ravin Garg, MD
Research Coordinator:  Emily Ross, CCRC  (443) 481-5811

E2108: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer. Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer,
Website:  http://clinicaltrials.gov/ct2/show/NCT01242800?term=E+2108+BREAST+MARYLAND&rank=1
Principal Investigator: Robert Buras, MD
Research Coordinator:  Kristen Sawyer, CCRA (443)481-5749

J0737: A Feasibility Study of a Novel Technique to Identify Circulating Breast Cancer Cells in Patients with Metastatic Breast Cancer
This research study is being done to help develop a new technique in isolating circulating breast cancer cells in blood and other fluids in the body. This new technique may help us to use the cells in ways to understand more about how breast cancer begins and spreads.
Website:   http://www.clinicaltrial.gov/ct2/show/NCT00897338?term=metastatic+breast+johns+hopkins&state1=NA%3AUS%3AMD&rank=7 �
Principal Investigator: Dr. Stephen Cattaneo, MD. (443) -481- 3366
Research Staff:  Emily Ross, CRCC (443) 481-4392

CCCWF 97609: Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity
The purpose of this research study is to see if the skin reaction patients have to radiation therapy planned by their doctors is related to substances in the patient’s blood and urine. Questions related to their quality of life will be asked during the study. This study will be done in different racial and ethnic groups.
Website:  http://clinicaltrials.gov/ct2/show/NCT01407770?term=Impact+of+Genomics+and+Exposures+on+Disparities+in+Breast+Cancer&rank=1
Principal Investigator: Dr. Mary Young, MD. (410) 443-5800
Research Staff:  Elizabeth Egan, RN (443) 481-5811

Meaning, Self Efficacy and Spirituality in Young Women Living with Metastatic Breast Cancer
This study will look at the emotional, social, and spiritual needs of young women living with Metastatic Breast Cancer through a confidential interview process.  Women between the ages of 21-45 who have been diagnosed in the past 5 years with MBC may be  eligible for this study.
Principal Investigator:  Cheryl Fisher, M.S., NCC, LCPC – (443)-223-5889

NSABP B39 / RTOG 0413:  A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) vs. Partial Breast Irradiation (PBI) for Women with Stage 0, I or II Breast Cancer
The purpose of this clinical trial is to study different types of radiation therapy.  This study may help determine which radiation therapy, whole breast or partial breast, is more effective in women who have undergone surgery for ductal carcinoma in situ (DCIS) or stage I or stage II breast cancer.
Website: http://clinicaltrials.gov/ct2/show/NCT00103181?term=NSABP+B39+BREAST&rank=2
Principal Investigator: Dr. Mary Young – (443)481-5800
Research Coordinator: Elizabeth Egan, R.N. – (443)481-5811

D-CARE: A Randomized Double-Blind Placebo Controlled Multi-center Phase III Study of Denosumab as Adjuvant Treatment for Women with Early Stage Breast Cancer at High Risk for Recurrence
This study will evaluate if an investigational medicine, denosumab, can prevent the spread of cancer to the bone or to other parts of the body when it is given in addition to standard of care therapy.
Website: http://thedcarestudy.com/2057amgen/index_usa.htm
Principal Investigator: Dr. Jeanine Werner (410)573-5300
Research Coordinator: Carol Bell, RN – (443)481-4393

Tissue and Blood Library Establishment for Molecular, Biochemical and Histologic Study of Breast Disease
The purpose of this clinical trial is to collect breast tissue, lymph node tissue, blood samples and data (information) about patient health for use in current and future research studies on breast cancer and breast diseases.  It is also possible that this blood and tissue may be used in research to learn more about other types of cancer and other diseases. The research that may be done with the blood or tissue collected is not designed specifically to help the patient from whom it is collected. This study is for patients that are scheduled to have part of all of their breast tissue surgically removed as part of their clinical care.
Principal Investigator:Dr. Lorraine Tafra – (443)481-5300
Research Coordinator:Peggy Eckhauser, R.N. – (443)481-5757