J0805: Partial Breast Irradiation with Concurrent Chemotherapy

The primary purpose of the study is to assess the potential acute and late skin and subcutaneous toxicities of partial breast irradiation concurrent with chemotherapy (PBIC). It is also planned to assess cosmetic effect and local control rate of patients treated with PBIC. All females greater than or equal to 18 years of age with confirmed adenocarcinoma of the breast may join. Patients must have had a bilateral mammogram prior to surgery and undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Patients must be registered on study such that radiation therapy begins no sooner than 7 days prior to, but no later than 7 days after, day 1 of chemotherapy. The chemotherapeutic regimen will be chosen by the patient and her medical oncologist. There will be 15 weekday treatments of radiation therapy.

J0805 Summary Document

J05118: Feasibility Study of Combination Therapy with Breast Tumor Vaccine for HER-2/neu-Overexpressing Metastatic Breast Cancer

This is a feasibility study to examine combination therapy with Trastuzumab (T) in a dose and schedule known to be effective against HER-2/neu-overexpressing breast cancer, low doses of Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine. Both T and CY are known to have immunomodulatory effects that might enhance vaccine activity. The purpose of this study is to determine the safety of this combination therapy and evaluate whether CY and T makes the breast cancer vaccine work better in patients with HER-2/neu-overexpressing Stage IV breast cancer. This study is open to adult men and women with HER-2/neu-overexpressing metastatic breast cancer who have stable disease after chemotherapy or hormonal therapy. Patients currently on T, hormonal and/or bisphosphonate therapy or with prior adjuvant T therapy are also eligible. After patients have signed the informed consent to participate, they will be evaluated for eligibility to participate. Patients will receive repeated cycles of CY and vaccine every four to six weeks for up to four complete cycles in the setting of weekly T therapy. Patients will be evaluated clinically and with laboratory testing for evidence of disease progression after each cycle, or when otherwise clinically indicated. Skin punch and tumor core needle biopsies will be obtained in addition to study blood samples during the study.

E5103: AC followed by Pacitaxel with Bevacizumab/Placebo as Adjuvant Chemotherapy Treatment

The purpose of this study is to determine if adding bevacizumab to standard treatment with doxorubicin and cyclophosphamide, followed by paclitaxel will increase how long patients live without a recurrence of breast cancer (also called "disease free survival"). The study will also compare short-term (20-24 weeks) versus long-term (50-54 weeks) bevacizumab therapy. Women and men with newly diagnosed lymph node positive or high risk lymph node negative breast cancer who also meet the following may be eligible: have a HER2 negative cancer, have had a mastectomy or lumpectomy and evaluation of the lymph nodes, have no evidence of breast cancer after surgery, and do not have a history of significant heart disease. All patients will receive doxorubicin and cyclophosphade ("AC"), followed by paclitaxel (or Taxol). Patients will be randomized (like the flip of a coin) to receive either bevacizumab or placebo during the first 7 cycles of treatment; neither the patient nor the doctor will know what treatment group the patient is in. After those 7 cycles, the patient and the doctor will be told whether bevacizumab or placebo was given. After the standard chemotherapy has ended (8 cycles) some patients may receive additional, long-term bevacizumab therapy. All patients will be asked to give a single blood sample and allow access to tissue collected from their surgery for special research tests.

J07110: Acupuncture in Aromatase-Inhibitor Related Musculoskeletal Pain

This research is being done to find out if acupuncture can ease or reduce the joint and/or muscle discomfort experienced from taking aromatase inhibitors (AIs). Breast cancer patients taking aromatase inhibitors, which include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara) who have never had acupuncture before and are experiencing joint stiffness or pain that is thought to be due to the AI may join this study. Participants will be asked to sign a consent form and answer questions to make sure that they are healthy and eligible to take part in the trial. They will come to the clinic once a week for 8 weeks, with a follow-up visit after about 6 months. Blood samples and questionnaires for the study will be collected.

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

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

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.

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

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: