Clinical Trial: Prospective Multicenter Study of the Role of Positron Emission Mammography in Pre-Surgical Planning for Breast Cancer

Funded by Naviscan PET Systems, Inc., www.naviscanpet.com

PI: Wendie A. Berg, MD, PhD, FACR, American Radiology Services, Johns Hopkins Green Spring

In women with newly diagnosed breast cancer who are thought to be candidates for lumpectomy surgery, mammography and clinical breast examination often do not depict the full extent of cancer. As a result, positive margins are common at the initial treatment surgery. Magnetic resonance imaging (MRI) has been shown to be highly sensitive in depicting the full extent of tumor in both the breast with cancer and the opposite breast, and is often used in planning treatment. There are, however, many noncancerous lesions that show up as suspicious on MRI. Positron emission mammography (PEM) is another way to image breast cancer, using a high-resolution PET scanner to image areas where there is increased metabolism of glucose. In preliminary studies, PEM appears to be equivalent to MRI at showing cancer, but it may be less likely to show noncancerous lesions. In this clinical research study, participants will have both a contrast-enhanced MRI of the breast(s) and a PEM study. The MRI is billed to insurance as part of usual care. The PEM study is performed at no charge at American Radiology Services, Timonium Crossing Office. The purpose is to determine whether MRI or PEM is better at predicting the actual extent of tumor and at helping surgeons to perform the most appropriate breast surgery at the time of initial diagnosis.

If interested in participating, please contact Kathy Wetzel at kwetzel08@gmail.com or Dr. Wendie Berg at wendieberg@gmail.com.

J0524: DNA Methylation Predictive Marker of Progression and Survival Following Systemic Therapy

In many cancers, the function of normal portions of DNA is silenced by a process called methylation. In past studies, we developed a special test to examine DNA in cancer tissue, in normal tissue, and in blood. We now want to use this test to look at the changes in the cells after receiving breast cancer treatment. If successful, it may be possible to know sooner if a treatment is working for a patient or if it is not. We hope that the information we learn in this study might lead to future studies where we look at whether or not it is possible to successfully make a change in treatment based on this test. Eligible individuals are breast cancer patients with evidence of metastatic disease who are about to begin a new treatment regimen of any kind -OR- healthy women without evidence of cancer in the last 5 years (except certain skin or cervical cancers). Weare requesting research bloods prior to starting treatment and at two (2) follow-up visits in breast cancer patients and up to 2 times from individuals without cancer.

We know that breast density (the thickness of the breast), blood hormones levels, inflammation levels and certain genes are factors that have been associated with an increased risk of breast cancer. The purpose of this study is find out if taking simvastatin for 24 weeks reduces certain factors which are associated with breast cancer risk. All subjects receive simvastatin. Simvastatin is an oral medication taken on an outpatient basis once each day. There are study-specific blood tests collected periodically during the trial as well as optional normal (contralateral) breast biopsies. Simvastatin is provided free-of-charge to patients in this trial. For more information, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=J0485

The purpose of this study is to look at the changes in contralateral breast density (the breast not involved with cancer) as well as changes in the blood including hormone levels (such as estrogen) and DNA (or "genes") in postmenopausal women with breast cancer who receive aromatase inhibitor treatment. Patients will be randomized (like the flip of a coin) to receive the aromatase inhibitor letrozole (Femara) or exemestane (Aromasin) - the drug will be provided free to all patients for the 2 years of the study. For more information, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=J0558

Many women with early-stage breast cancer are advised to receive chemotherapy in addition to hormonal therapy, yet research has not shown that chemotherapy benefits all of them equally. The TAILORx trial will use the Oncotype DX test results to assign patients to either chemotherapy + hormonal therapy or hormonal therapy alone based on their Oncotype DX Recurrence Score (RS). Patients with an RS of 11-25 will be randomized to receive either chemo/hormonal therapy or hormonal therapy alone. The choice of which type of chemotherapy and hormonal therapy is given will be determined by you and your physician. For more information, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=EPACCT1

Chemotherapy is sometimes given prior to surgery to shrink breast tumors to allow breast conserving surgery (lumpectomy) or to improve the chance that the tumor can be removed adequately by mastectomy. Recent studies have shown that estrogen lowering drugs called "aromatase inhibitors" are an effective and less toxic alternative for postmenopausal women with hormone receptor positive tumors. The primary purpose of the Z1031 study is to find out which aromatase inhibitor is the best one to use for future ACOSOG studies. All three aromatase inhibitors under investigation have been shown to shrink breast cancers. Patients will be treated with 16 weeks of either: exemestane, letrozole or anastrozole. Another aim is to develop new tests that can be used to predict which patients do well with this form of treatment. For this reason your consent will be requested for extra tumor biopsies and for access to tumor samples taken at surgery. For more information, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=ACOSOGZ1031

The goal of this study is to look at the effects of giving a statin (simvastatin) in combination with anastrozole. We are looking for patients who are taking anastrozole for breast cancer prevention or as part of their adjuvant breast cancer treatment and who would be interested in taking simvastatin for 2 weeks. Patients cannot already be taking a statin or have taken a statin in the past month. The study involves collection of research bloods prior to starting simvastatin and after 14 days. The simvastatin medication will be provided to patients during the study and subjects will continue to take anastrozole as prescribed by their doctor. For more information, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=J05100

This research is being done to find out how often lymphedema (swelling of the arm) happens after sentinel lymph node or axillary lymph node dissection. The study will use arm measurements, a symptom survey and a hand and arm function questionnaire to screen for lymphedema in breast cancer patients. People having surgery for their breast cancer at Johns Hopkins which includes a sentinel node or axillary node dissection may join. It is estimated that there will be 400 patients in this study. Please contact us for more information about this study.

The Breast and Ovarian Surveillance Service (Boss) Cohort Study (CHR#H.34.04.08.17.A2), Principal Investigator: Kala Visvanathan, MD, MHS

Women 18 years and older are needed to participate in an outpatient study looking at factors associated with breast density, and breast and ovarian cancer. This study is being conducted in families with a personal or family history of breast or ovarian cancer.

Eligible candidates must be 18 years of age and meet one of the following criteria: have a family history of breast or ovarian cancer in one first or two second- degree relative(s) on the same side of the family OR have a personal history of breast and/or ovarian cancer with no family history but an enrolled first-degree or (2) second-degree relative(s); OR have a mutation in the breast cancer susceptibility genes BRAC1 or 2. Women joining the study will be asked to review and sign a consent form, provide one blood sample (about 3 tablespoons) complete a questionnaire that contains questions on lifestyle, reproductive history, breast and ovarian cancer risk factors, and genetic test results and give permission to borrow recent mammogram(s) to assess breast density. Study visits will be conducted at Johns Hopkins Hospital and Johns Hopkins at Greenspring Station. For more information about this study contact the BOSS Cohort Research Coordinator at (443) 287-6144.

P.A.C.T.
PI is Robert Edwards, MD

This study is being conducted to improve clinicians' abilities to predict and take a proactive approach to pain after breast cancer surgery. We are currently recruiting women who are at least 21 years old who have been recently diagnosed with stage 0 or stage 1 breast cancer and will undergo a lumpectomy. The study consists of 3 visits to Johns Hopkins Behavioral Medicine Clinic that will include questionnaires related to personal outlook and coping styles, quantitative sensory testing, and the use of an electronic diary. The three visits can be scheduled for times convenient to your visits with the breast cancer outpatient center and you will be compensated for your time and parking. For more information and to participate in this study, please contact Tarek Kronfli, Study Coordinator at (410) 614-3396.

J0503

A Phase I Study Assessing the Feasibility and Safety of Intraductal Administration of Pegylated Liposomal Doxorubicin (Doxil) in Women with Breast Cancer

This study is being done to look at the feasibility and safety of giving a common chemotherapy drug (doxorubicin or Doxil) into the breast ducts of women with breast cancer awaiting mastectomy. Women with newly diagnosed breast cancer awaiting surgery with mastectomy are eligible; prior preoperative treatment is allowed (chemotherapy, trastuzumab, and/or hormonal treatment). Women with a prior excisional biopsy, radiation therapy, or surgery to the involved breast, or history of implant, are not eligible. The first 3 patients on the study will receive a sugar solution (dextrose) in the breast duct only to look at the feasibility of the study. Future patients will receive increasing doses of doxorubicin based on tolerance. There are study-specific blood tests collected periodically during the trial. The doxorubicin is provided in this trial.

For more information about this study, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=J0503

J0504

A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydoxamic Acid (SAHA) in Women with Newly Diagnosed Breast Cancer

The purpose of this study is to look at the safety of giving an experimental drug, SAHA, to women prior to breast cancer surgery. We will also look at the effects of the drug on breast cancer tissue. Women with a newly diagnosed breast cancer awaiting surgery with mastectomy or lumpectomy are eligible. Women must not have received prior preoperative treatment of any kind allowed and any hormone replacement therapy must have been stopped at least 30 days prior to starting the study. All subjects will receive SAHA for the 3 days prior to breast cancer surgery. There are study specific blood samples collected prior to starting the study drug and on the day of surgery. SAHA is provided in this trial.

For more information about this study, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=J0504

J0381: Phase I/II Partial Breast Irradiation with Concurrent Chemotherapy
PI is Dr. Richard Zellars

Standard chemotherapy and radiation can last more than 6 months. This long course of treatment can cause you to lose time from work and family and seriously decrease your quality of life. Faster and easier treatments are needed and may be on the way. We are conducting a study in which the total course of chemotherapy and radiation for breast cancer is decreased from approximately 6 months to less than 2 months! We are currently seeking women with newly diagnosed breast cancer to participate in this study.

What is the background for this research study?
Studies have shown that a lumpectomy (or breast conserving therapy) is as effective a treatment as mastectomy for many women with breast cancer, but almost all women having lumpectomy need daily radiation treatments for 5 to 7 weeks following their surgery.

Unfortunately, many women choose to have a mastectomy because of the difficulty and inconvenience of 7 weeks of daily radiation. New techniques for shortening the length of radiation treatments are being tested in order to allow women greater freedom to choose the therapy that best reflects their desires.
At Johns Hopkins, we are investigating the use of partial breast irradiation for patients who would be candidates for breast conserving therapy (lumpectomy). With this approach only part of the breast is treated. Because a smaller area is receiving the radiation, a larger dose of radiation can be given each day. This allows patients to receive the same effective dose of radiation in a shorter period of time. In this study, radiation is given daily (weekends not included) for 3 weeks.

What is the purpose of this research study?
The purpose of this research study is to evaluate the side effects and effectiveness of treating only part of the breast with full dose radiation while also receiving chemotherapy.

Who is eligible for this study?
Women with newly diagnosed breast cancer who are candidates for breast conservation therapy (lumpectomy) and will be receiving Adriamycin and Cytoxan chemotherapy may participate in this study. Patients may also receive additional chemotherapy after completing their radiation therapy and Adriamycin/Cytoxan treatments if that has been recommended by their medical oncologist.

What is involved in this study?
After a consent form is signed, a special PET/CT or CT will be obtained to plan the radiation. The radiation may be started within 2 days of your chemotherapy and will last a total of 15 treatments (3 weeks). The chemotherapy, given with radiation, will be delivered once every two weeks for a total of 4 times. This course of therapy (radiation and concurrent chemotherapy) will last 7 weeks. You will be evaluated for side effects twice a week during radiation and once a week until the completion of chemotherapy. After the chemotherapy is complete you will be asked to return for a follow-up on our routine schedule, every 3 - 6 months for 5 years then annually afterwards.

Who can I contact to get more information about this study?
Please call (410) 614-3158 for more information.

Partial Breast Irradiation Clinical Trial.
PI- Dr. Richard Zellars

For more information click on: http://www.radonc.jhmi.edu/html/partial_breast_irradiation.html

This research is being done to find out how often lymphedema (swellingof the arm) happens after sentinel lymph node or axillary lymph nodedissection. The study will use arm measurements, a symptom survey, and ahand and arm function questionnaire to screen for lymphedema in breastcancer patients. Patients who are having a sentinel lymph node oraxillary dissection are invited to participate in the study.

RTOG study for DCIS, principal investigator: Fariba Asrari, MD

This is a randomized trial for noncomedo DCIS, grade 1 or 2 with size of 3cm or less and clear margin of 3mm or more. All patients need to have had lumpectomy surgery only and then are randomized to no further radiation therapy vs radiation therapty to breast only.

J0425

Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer

This study is being done to determine the feasibility of using a simple non-BSA, fixed starting dose of capecitabine (Xeloda®) and to determine pharmacogenetic and pharmacokinetic parameters that can help predict for toxicity and response. All subjects receive capecitabine. Capecitabine is an oral medication taken on an outpatient basis twice-each day for 14 days followed by 7 days of rest (1 cycle = 21 days) and is provided free-of-charge to patients in this trial. For more information about this study, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=J0425.

IBCSG-24-02(SOFT): A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer

This study is being done to see if shutting down the ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just giving tamoxifen alone in premenopausal women. It will also look at whether a hormone drug called exemestane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries. For more information about this study, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=EIBCSG2402

J0085: A Phase I Vaccine Safety and Chemotherapy Dose-Finding Trial of an Allogeneic GM-CSF-secreting Breast Cancer Vaccine Given in a Specifically Timed Sequence with Low, Immunomodulatory Doses of Cyclophosphamide and Doxorubicin (Principal Investigator: Leisha A. Emens, M.D., Ph.D.)

This is a Phase I study of a cellular breast cancer vaccine given in sequence with low doses of Cyclophosphamide and Doxorubicin. The cellular breast cancer vaccine is investigational. The study is only open at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. It is open to men and women with metastatic breast cancer who have been treated with any number of prior chemotherapy regimens for metastatic disease, and have had stable disease after chemotherapy or on hormonal therapy. Concurrent hormone therapy and/or bisphosphonates (standard breast cancer therapy that is not chemotherapy or other investigational therapy) is allowed. The study will test the breast cancer vaccine given in timed sequential therapy with low doses of Cyclophosphamide and Doxorubicin. The chemotherapy is not included for its ability to shrink tumors, but rather to test whether or not it can better enable the vaccine to activate the immune system against the breast cancer. The doses of chemotherapy drugs are about 30% of those used in standard therapy. The goal of the study is to determine the doses of chemotherapy that maximize vaccine-activated immunity, and to test the safety of the vaccine combined with chemotherapy. For more information about this study, please visit: http://www.hopkinskimmelcancercenter.org/clinicaltrials/index.cfm?action=3&protocolnumber=J0085

PET Scan for Breast Cancer-- Dr. Richard Wahl, principal investigator

There is a new research study will include those with newly diagnosed breast carcinoma scheduled for sentinel or armpit node dissection, or who will be receiving chemotherapy for known primary tumor or recurrence.

This work will try to determine the imaging capability of PET scanning for tumor detection and evaluating the response of tumors to therapy. Such data may allow for more rational planning of therapeutic protocols in the future.

If you are interested in learning more about this study, a research associate from the PET for Breast Cancer Study-- Barbara Levit at 410-502-5828 or Madge Murrell at 410-614-2416..

BIOLOGICAL MARKERS IN BREAST FLUID FOR EARLY DETECTION OF BREAST CANCER

We are studying a new approach for early detection of breast cancer, called nipple aspiration of breast fluid. This study is part of the Early Detection Research Network (EDRN) sponsored by the National Cancer Institute (for more details on the EDRN, see http://www3.cancer.gov/prevention/cbrg/edrn ). This approach may allow us to detect the very early abnormalities in breast cells that cannot be seen with mammography or other methods. The test is simple, quick, and non-invasive (no needles or anything penetrating the breast). In contrast to mammography (which may be less sensitive with younger women because their breast tissue is more dense), the nipple aspiration method may be more sensitive in pre-menopausal women. This could make the test especially useful for women with a family history of breast cancer who may need to begin surveillance during the pre-menopausal years. Thus, if it is proven to be successful, it will be used in addition to mammography for early detection.

Nipple aspiration involves taking a small sample of breast fluid that is normally present in a woman's breast. A simple pump that works like a breast milk pump is used to remove the fluid. We will examine the fluid for certain proteins or other substances produced by breast cells. By analyzing these compounds we may detect evidence that the cells are beginning to undergo pre-cancerous changes. Because such changes may occur very early in the process of developing breast cancer, we hope that this test will allow breast cancer to be detected at the very earliest stage. However, the test is still experimental. Your participation can help us to determine whether this test will be useful for early detection of breast cancer.

Eligibility criteria: