J0888: Hopkins Breast Cancer Repository Study

Women with or without a diagnosis of breast cancer may be eligible to enroll in a study seeking to collect samples for future studies. If you are interested, please contact us at hopkinsbreasttrials@jhmi.edu for more information.

J0898: BEAM Study

This study is for women without a history of breast cancer. The BEAM Study (Breast Estrogen and Methylation) is designed to look for ways to better estimate a woman’s risk for breast cancer. Currently, our ability to estimate who may develop breast cancer is poor. One estimate of a woman’s breast cancer risk is based on personal and family medical history. Another estimate uses mammograms to detect the degree of density in a healthy breast because a woman's risk of breast cancer increases if her breasts are dense (harder and less fatty) as opposed to more fatty. There is also information that production of hormones, such as estradiol and progesterone, in the breast can influence cell growth and therefore risk of breast cancer. In addition, there are genes that help block the formation of cancer, and if these genes are not actively expressed or are “silenced” through a change called “methylation”, the risk of cancer may increase. Eligible women include: ages 35-60, mammogram within the last 3 months, no birth control or hormone therapy in the last 3 months, not pregnant or breast-feeding in the last 2 years, no diagnosis (past or present) of breast cancer. The study involves 1 visit to the Johns Hopkins Avon Breast Center where blood and tissue samples from the breast will be collected for research studies. Participants will be compensated for their time. If you are interested, please contact us at hopkinsbreasttrials@jhmi.edu for more information.

J0907: Cisplatin or Carboplatin in Metastatic Breast Cancer

Cisplatin and carboplatin are anti-cancer chemotherapy drugs that stop cancer cells from growing and are used to treat other cancers. Cisplatin and carboplatin have also been used in breast cancers and the researchers think that they may be more effective in triple-negative breast cancer than in other kinds of breast cancer. The purpose of this study is to find out how effective cisplatin or carboplatin is in lengthening the time it takes for breast cancer to grow. Women with “triple negative” (ER, PR and HER2 negative) metastatic breast cancer, with no more than 1 prior chemotherapy for their disease may be eligible. Cisplatin and carboplatin are given in the clinic, once every 3 weeks, and the decision of which drug patients will receive is not decided by the study, but by the patient and her doctor.

J07117: Aromatase Inhibitors in Chemotherapy-Induced Ovarian Failure

The primary goal of this research study is to see what effects the drug anastrozole has on the function of a woman’s ovaries. We also hope to find out how often blood tests need to be done to determine whether the ovaries start working again or not. Study candidates are those 18 to 60 years of age, diagnosed with hormone positive breast cancer for which they received a cytoxan based chemotherapy, and who were premenopausal prior to starting the chemotherapy. The candidates must have completed chemotherapy and have not menstruated in greater than the last 8 weeks. A routine blood test must have been done that shows hormone levels in the postmenopausal range. If you are eligible, you will start the anastrozole medication. Because we do not know if your ovaries will wake up while you are taking the anastrozole, we will be checking your estrogen levels every 2 weeks for the first 3 months, then every 4 weeks for the next 4 months, then every 8-12 weeks for the next 11 months. If your ovaries start functioning again, as shown by the blood tests, you will stop taking part in the study and will discuss other treatment options with your doctor.

J07135: Taxol and Herceptin as Adjuvant Treatment in Node-Negative Breast Cancer

The purpose of this study is to find out what effect the postoperative combination of the therapies paclitaxel (Taxol) and trastuzumab (Herceptin) will have on your breast cancer. Women with HER2 positive breast cancer with tumors less than or equal to 3 centimeters in size, and who have completed either a lumpectomy or mastectomy may take part in the study. Women cannot have any evidence of metastatic disease. Enrollment onto the study must be completed within 90 days of the final breast cancer surgery. All patients will receive treatment with paclitaxel and trastuzumab. This treatment is given together weekly in the clinic for 12 weeks. Once the 12 weeks of paclitaxel and trasutzumab are completed, the trastuzumab is given every 3 weeks or weekly, for up to 40 additional weeks.

J08129: Effect of Antidepressants and Gabapentin on Tamoxifen

Tamoxifen is a common treatment for many women with breast cancer. The purpose of this study is to learn if different medications used with tamoxifen affects how the body breaks down the medication. This information may help doctors in the future better understand how to use tamoxifen and other medications in the future. In order to qualify for this study, women must: have been taking tamoxifen for at least 4 weeks for any stage of breast cancer, or for prevention of breast cancer; have been recommended to use of one of the following medications venlafaxine (Effexor), citalopram (Celexa), escitalopram (Lexapro), gabapentin (Neurontin), or sertraline (Zoloft) which has not been started yet; and, be willing/able to have blood drawn 2 times. The study involves the CYP2D6 test and results will be given to patients and their doctors.

J0947: Comparative Study of Combination Therapy with Breast Tumor Vaccine with or without Trastuzumab for HER2-Negative Metastatic Breast Cancer

This is a trial designed to look at whether adding Trastuzumab (T) to low doses of Cyclophosphamide (CY) sequenced with an allogeneic GM-CSF-secreting whole cell breast cancer vaccine can enhance vaccine-activated immunity in patients with Stage IV breast cancer that does not over-express HER-2/neu. The purpose of this study is to determine the safety of the two combination vaccine therapies, and to evaluate whether Trastuzumab combined with CY can make the vaccine work better than CY alone. This study is open to adult men and women with metastatic breast cancer that does not over-express HER-2/neu. Patients currently on hormonal and/or bisphosphonate therapy are eligible for this study. Patients will receive up to 4 cycles of CY and vaccine, with or without T. Patients will be evaluated clinically and with laboratory testing for evidence of disease progression after each cycle, or when otherwise clinically indicated. Samples for research studies, including blood and skin punch biopsies, will be obtained during the study.

ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study

The purpose of this research study is to: 1) find out what effects the study treatment has on you and your cancer, 2) compare four different study treatment combinations to see if one is better, and 3) find out what effects this study has on your quality of life. Patients with non-metastatic, operable, and HER2 + (either 3+ by IHC and /or FISH positive) primary breast cancer will be considered eligible. Patients must have completed definitive surgery and received at least 4 cycles of an approved adjuvant anthracycline based chemotherapy for primary breast cancer. Patients will be “randomized” into one of the four study groups: Group 1: Trastuzumab, given intravenously, weekly with Paclitaxel for 12 weeks, then changed to Trastuzumab alone every 3 weeks for 9 months. Group 2: Lapatinib, a pill taken daily, taken first with Paclitaxel for 12 weeks, and then daily for 9 months. Group 3: Trastuzumab, given intravenously, weekly with Paclitaxel for 12 weeks, then a 6 week break, then start on Lapatinib pill taken daily for approximately 8 months. Group 4: Trastuzumab given intravenously, weekly with Paclitaxel for 12 weeks, then changed to Trastuzumab every 3 weeks for 9 months, plus Lapatinib pill taken daily starting along with the Trastuzumab, and Paclitaxel. Lapatinib will be taken daily for 1 full year on this arm. Lapatinib will be provided free of charge while you are taking part in this study.

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

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.

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.

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: