Clinical Trials Under Way for Patients with Breast Cancer

October 2015, Vol 5, No 7 - Breast Cancer, Clinical Trials Tracker


The following trials represent a selection of key clinical trials that are currently recruiting patients with breast cancer for inclusion in investigations of new therapies for breast cancer. Each trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their appropriate patients to one of these clinical trials.

1 Feasibility and Validation of Genomic Testing for Breast Cancer

The purpose of this observational study is to determine whether genetic testing can be used on breast cancer tumor samples to predict if the tumors will respond to treatment. Women aged ?18 years who have not received previous systemic or radiation therapy for breast cancer, and whose clinical or radiologic primary tumor size is ?1 cm in diameter, may be eligible for enrollment if other criteria are met. Eligible patients will have a tumor biopsy before receiving any drugs to treat their breast cancer. Tumor samples will be taken once, during a planned breast cancer screening biopsy or surgery to remove known breast cancer, or, if the breast cancer has been previously biopsied and a physician plans to provide treatments before surgery, before starting the treatment drugs. Samples collected for this study will be approximately the size of a pencil tip.

The primary outcome measure is a feasibility analysis of genomic predictors based on a localized invasive breast cancer tumor registry. Success will be defined as being able to classify patients into 1 of 4 groups based on the results from genomic analyses of their tumor samples. Feasibility is dependent on achieving a minimum success rate from acceptable samples of primary tumor in a sufficiently large cohort of eligible patients spanning ?12 months of patient accrual. This study plans to enroll 500 patients in Houston, TX.

For more information, contact Stacy Moulder, MD, at 713-792-2817. The NLM Identifier is NCT01334021.

2 Aerobic Exercise After or During Adjuvant Therapy for Operable Breast Cancer

This randomized, open-label study seeks to compare the effects of aerobic exercise during and after chemotherapy in women who have recently had surgery after a diagnosis of early-­stage breast cancer. Women aged ?21 years with a negative pregnancy test ?3 months of starting the intervention, without unstable angina, and who receive approval from their primary attending oncologist may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive supervised aerobic training either during or after therapy, continuous supervised aerobic training during and after therapy, or standardized brochures explaining the benefits of exercise on breast cancer prevention.

The primary outcome measure is a change in oxygen consumption per unit time peak over a time frame of 36 weeks, during chemotherapy, and depending on treatment recommendations. Secondary outcome measures include quality of life during and after chemotherapy, sleeping patterns, and skeletal muscle function. This study expects to enroll 160 patients at Memorial Sloan Kettering Cancer Center in New York, NY.

For more information, contact Lee Jones, PhD, at 646-888-8103, or Chau Dang, MD, at 646-888-5426. The NLM Identifier is NCT01943695.

3 HER2-Directed Therapy for HER2-Positive Breast Cancer with Brain Metastasis

The purpose of this open-label study is to determine whether stereotactic radiosurgery followed by an HER2-directed therapy regimen results in a 6-month relapse rate of <30% for distant brain metastasis. Patients aged ?18 years with a histologically proven diagnosis of HER2-positive breast cancer, 1 to 10 newly diagnosed brain metastases, and adequate renal function within 14 days of registration may be eligible for enrollment if other criteria are met. Eligible patients will receive stereotactic radiosurgery plus HER2-directed therapy. Anti–HER2-based systemic therapy will last until disease progression, discontinuation, unacceptable toxicity, or until the physician deems it is no longer indicated.

The primary outcome measure is the relapse rate measured over a time frame of 12 months. The secondary outcome measures include describing adverse events, the patterns of local brain relapse, and the natural history of neurocognitive function in women with brain metastases who were treated with stereotactic radiosurgery and HER2-directed systemic therapy to establish a reference benchmark for generating hypotheses for future design of a phase 3 trial. This study plans to enroll 44 patients at the University of Maryland Marlene and Stewart Greenebaum Cancer Center in Baltimore, MD.

For more information, contact Bahiyyah Jackson, MS, at 410-328-7586 or bjackson1@umm.edu; or Suzanne Grim, MS, at 410-328-7501 or sgrim@umm.edu. The NLM Identifier is NCT01924351.

4 Cryoablation without Lumpectomy in Early-Stage Breast Cancer

Researchers in this open-label, single-group study are seeking to examine the efficacy of cryoablation without lumpectomy and its influence on local and distant recurrence of early-stage breast cancer. Women aged ?65 years with a diagnosis of invasive ductal breast carcinoma via core needle biopsy and breast size suitable for safe cryoablation may be eligible for enrollment if other criteria are met. Eligible patients will be treated with the IceSense3 cryoablation procedure.

The primary outcome measure is a local in-breast tumor recurrence rate over a time frame of up to 5 years. The secondary outcome measures include the complete ablation of the primary tumor ?60 months after cryoablation, the improvement or maintenance of quality of life, and satisfaction with breast cosmetics. This study expects to enroll 150 patients at multiple locations across the United States.

For more information, contact Elisabeth Sadka at 724-623-0333, ext 223, or elisabeth@icecureedical.com; or Susan Jepsen at 313-520-2416 or sjepsen@icecuremedical.com. The NLM Identifier is NCT02200705.

5 Breast Density Changes and Breast Cancer Risk

The purpose of this retrospective, controlled study is to gather health information and to look at changes in breast density over time, and to evaluate the risks for breast cancer in healthy women and women with breast cancer. Women aged ?50 years who are either patients with histologically confirmed breast cancer with known tumor stage that was diagnosed between the years 2002 and 2004, or healthy participants receiving routine medical care (eg, screening mammograms) within the University Hospitals system may be eligible for enrollment if other criteria are met. Eligible patients will complete self-administered questionnaires and will undergo mammographic density assessments.

The primary outcome measures are the determination of mammographic density longitudinal change trajectory in healthy women and in women with breast cancer to assess the within-individual mammographic density longitudinal change and breast cancer risk. These measures are being assessed to conclude whether healthy women and patients with breast cancer manifest different patterns of within-individual mammographic density change, and to evaluate the predictors of across-­individual differences. Whether the developmental profile of mammographic density differs systematically between patients with breast cancer and healthy individuals will also be measured. This study expects to enroll 3000 patients at multiple locations throughout Ohio.

For more information, contact Li Li, MD, PhD, at 216-844-3944 or li.li@uhhospitals.org. The NLM Identifier is NCT00445445.

6 Impact of Breast Cancer on Employment Status, Finances, and Quality of Life

Investigators in this study are seeking to learn more about how treatment for breast cancer affects employment status, finances, and quality of life in women from various ethnic groups on short-term and long-term bases. Women aged 18 to 64 years who are survivors of breast cancer with a pathologic diagnosis of stage I to III breast cancer or who have not been treated for cancer in the past year may be eligible for enrollment if they are employed as full-time or part-time paid employees at the time of consent or <3 months before diagnosis, and if other criteria are met. Eligible participants will take part in web-based surveys or telephone interviews at baseline, follow-up, and at 3 to 4 months after the completion of treatment.

The primary outcome measure is to compare the impact of breast cancer on employment status, finances, and quality of life over a time frame of 3 years. The secondary outcome measures are to ascertain barriers to employment and how they correlate with employment status, finances, and quality of life; to develop procedures for evaluating discrimination in the job market using a validated instrument; and to determine whether a diagnosis of breast cancer exacerbates employment discrimination. This study plans to enroll 750 patients at Memorial Sloan Kettering Cancer Center in Basking Ridge, NJ, and at multiple locations throughout New York.

For more information, contact Victoria Blinder, MD, MSc, at 646-888-8216, or Francesca Gany, MD, MSc, at 646-888-8054. The NLM Identifier is NCT01134172.

7 Passive versus Active Interventions to Enhance Genetic Counseling Among Patients with Breast Cancer

The purpose of this randomized, controlled, parallel-assignment study is to compare active and passive interventions for increasing the rate of appropriate genetic counseling referrals for patients with newly diagnosed breast cancer who are at an increased risk for hereditary breast and ovarian cancer. Women aged ?18 years with newly diagnosed and pathologically confirmed primary breast cancer who have not had definitive surgical treatment may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive either passive (professional guidelines) or active (professional guidelines and referrals) provider interventions.

The primary outcome measure is the rate of appropriate referral of patients with newly diagnosed breast cancer who have an increased risk for hereditary breast and ovarian cancer to genetic counseling in the active intervention group versus in the passive intervention group. The secondary outcome measures, which will be assessed via a patient questionnaire and medical records, when appropriate, include the rates of genetic counseling uptake and bilateral mastectomy, cancer-related distress, and satisfaction with decisions regarding surgical treatment. This study plans to enroll 3780 patients at the SunCoast Community Clinical Oncology Program Research Base in Tampa, FL.

For more information, contact Rebecca Sutphen, MD, at 800-909-1242 or ccop@epi.usf.edu. The NLM Identifier is NCT01789684.

8 Vaccine Therapy and Cyclophosphamide with or without Trastuzumab

Investigators in this randomized, open-label, phase 2 trial are seeking to examine the side effects of cyclophosphamide in combination with vaccine therapy, in addition to how well it works compared with cyclophosphamide and vaccine therapy in combination with trastuzumab in patients with metastatic breast cancer. Patients aged ?18 years with histologically confirmed breast adenocarcinoma and unspecified hormone receptor status, and who are not eligible for therapy with known curative potentials for metastatic breast cancer may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive allogeneic granulocyte macrophage colony-stimulating factor–secreting breast cancer vaccines and cyclophosphamide with or without trastuzumab.

The primary outcome measures are toxicity, progression-free survival at 6 months, HER2/neu-specific immune responses, and the pharmacodynamics of peripheral CD4+ and CD25+ regulatory T-cells. The secondary outcome measures include immune priming in in-vivo vaccine-­site biopsies and characterization of the T-cell memory pool before and after vaccination. This study plans to enroll 60 patients at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, MD.

For more information, contact Maureen Berg, RN, OCN, at 443-287-6602 or mberg1@jhmi.edu. The NLM Identifier is NCT00971737.

9 Short-Term Fasting Before Chemotherapy in Patients with Newly Diagnosed Breast Cancer

The purpose of this phase 1 and 2 open-label, single-group study is to see how safe short-term fasting is in patients with breast cancer who will receive chemotherapy before surgery, to examine whether short-term fasting will decrease the side effects of chemotherapy, and to note how much a tumor shrinks during chemotherapy. Patients aged ?18 years with histologically and radiographically confirmed nonmetastatic breast cancer and a minimal tumor size of >1 cm who have been recommended to receive neoadjuvant chemotherapy by their treating physician, and who have an Eastern Cooperative Oncology Group performance status score of <1 may be eligible for enrollment if other criteria are met. All eligible patients will fast 24 hours before and after chemotherapy consisting of doxorubicin plus cyclophosphamide every 2 weeks for 4 cycles, followed by paclitaxel every 2 weeks for 4 cycles. The treatment arms will differ for patients with and without HER2- positive breast cancer.

The primary outcome measure is the complete pathological remission rate at the time of surgery or the partial pathological response rate at the time of surgery or biopsy after the completion of the planned chemotherapy. The secondary outcome measures include the effect of short-term fasting on neoadjuvant chemotherapy toxicity in patients with breast cancer, changes in plasma insulin abnormalities after short-term fasting and chemotherapy, and biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy. This study expects to enroll 40 patients at Western Regional Medical Center in Goodyear, AZ.

For more information, contact the Research Coordinator or the Research Nurse Coordinator at 623-207-3000 or westerntrials@ctca-hope.com. The NLM Identifier is NCT02379585.

10 Postchemotherapy Fat Metabolism in Patients with Breast Cancer

Researchers in this observational, prospective study are seeking to examine chemotherapy-related changes in lipid metabolism, gut digestion, and the absorption of fat in patients with breast cancer compared with the matched, healthy controls. Patients aged ?30 years with diagnosed breast cancer or no diagnosis of cancer, who have not used nutritional supplements within ?5 days of the first test day, and who do not have any acute illnesses or metabolically unstable chronic illnesses may be eligible for enrollment if other criteria are met. Eligible patients with breast cancer and healthy patients will be subjected to 5 and 3 clinical visits, respectively; have blood drawn; and fill out questionnaires, among other assessments.

The primary outcome measures are changes in hepatic triglyceride and hepatic triglyceride synthesis before and after a meal. The secondary outcome measures include changes in adipose tissue triglyceride synthesis and de novo lipogenesis before and after a meal, fat digestion and absorption after a meal, and skeletal muscle endurance and strength. This study plans to enroll 40 patients at Texas A&M University in College Station.

For more information, contact Marielle Engelen, PhD, at 979-220-2282 or mpkj.engelen@ctral.org; or Dillon Walker, PhD, at 979-587-1082 or dk.walker@ tamu.edu. The NLM Identifier is NCT01890824.

11Impact of Physical Activity on Biomarkers of Aging During Chemotherapy for Breast Cancer

Investigators in this prospective study are seeking to examine whether a physical activity intervention during chemotherapy for breast cancer can prevent p16, a marker of aging, from greatly increasing after chemotherapy. Women aged 21 to 59 years with histologically confirmed stage I to III breast cancer may be eligible for enrollment if other criteria are met. Eligible patients undergoing chemotherapy will partake in the Arthritis Foundation’s Walk With Ease program, an evidence-based walking intervention that helps with fatigue and pain.

The primary outcome measure is to compare the change in p16 from baseline to the end of chemotherapy for patients receiving a physical activity intervention to values determined in a previous study (LCCC810). The secondary outcome measures include the association of change in physical activity levels with change in p16 levels from baseline to the end of chemotherapy, as well as from baseline to 6 months after treatment, and the link between the change in physical activity levels and the changes in physical function, fatigue, and quality of life. This study plans to enroll 48 patients at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill.

For more information, contact Shani M. Alston, MPH, at 919-843-1906 or shani_alston@med.unc.edu. The NLM Identifier is NCT02167932.

12 Preoperative Ultrasound versus Magnetic Resonance Imaging for Newly Diagnosed Breast Cancer

The purpose of this nonrandomized, open-label, parallel-assignment study is to compare the use of preoperative automated breast ultrasound with magnetic resonance imaging (MRI) in patients with newly diagnosed breast cancer. Women aged ?18 years with a breast cancer diagnosis via core needle or excisional biopsy and who are currently undergoing preoperative evaluation at the University of Kansas Cancer Center may be eligible for enrollment if other criteria are met. Eligible patients will be divided into study arms comparing the overall sensitivity and specificity of automated breast ultrasound with MRIs and mammography.

The primary outcome measure is the rate of occult breast cancer detected by automated breast ultrasound that was not spotted via MRI. This study expects to enroll 200 patients at the University of Kansas Cancer Center in Westwood.

For more information, contact Amanda Amin, MD, at 913-588-6150 or aamin5@kumc.edu; or Kerry Hepler, RN, at 913-945-7552 or khepler@kumc.edu. The NLM Identifier is NCT02488187.

13 Intraoperative Radiation Therapy with Computed Tomography–Guided High-Dose Rate Brachytherapy for Patients with Breast Cancer

The purpose of this phase 2, open-label study is to examine an investigational method for providing radiation therapy to patients with early-stage breast cancer at the time of surgery. Women aged ?45 years with a tumor size ?3 cm whose breast cancer does not involve their skin or chest wall and who have chosen to have breast-conserving surgery or whole-breast irradiation for their early-stage breast cancer may be eligible for enrollment if other criteria are met. Eligible patients will receive intraoperative radiation therapy computed to­mography–guided high-dose rate brachytherapy at the time of their breast surgery.

The primary outcome measure is the rate of local breast tumor recurrence for a time frame of up to 60 months after treatment. The secondary outcome measures include the rates of ipsilateral breast tumor recurrence and of distant recurrence of breast cancer, as well as changes in quality of life, as reported by the patient. This study plans to enroll 260 patients in Charlottesville, VA.

For more information, contact Katie Rea, RN, 434-243-3015 or kaw3j@hscmail.mcc.virginia.edu. The NLM Identifier is NCT02400658.

14 Palbociclib with Bazedoxifene for Hormone Receptor–Positive Breast Cancer

Investigators in this open-label, phases 1 and 2 trial are seeking to examine the clinical benefits of using palbociclib in combination with bazedoxifene to treat patients with hormone receptor–positive breast cancer. Patients aged ?18 years with histologically confirmed metastatic or unresectable locally advanced invasive breast cancer and an Eastern Cooperative Oncology Group performance status score of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive oral palbociclib and bazedoxifene per the protocol.

The primary outcome measure is the clinical benefit rate of using palbociclib in combination with bazedoxifene in patients with advanced hormone receptor–positive and HER2-positive breast cancer. The secondary outcome measures include the number of patients with adverse events, the objective response rates, and progression-free survival. This study plans to enroll 37 patients at Beth Israel Deaconess Medical Center and Dana-Farber Cancer Institute in Boston, MA.

For more information, contact Rinath Jeselsohn, MD, at 617-632-2335 or rjeselsohn@partners.org. The NLM Identifier is NCT02448771.

15 Axillary Lymph Node Dissection versus Axillary Radiation

The purpose of this randomized, open-label, phase 3 trial is to compare the efficacy of axillary lymph node dissection to axillary radiation therapy as treatment for patients with node-positive breast cancer who are treated with neoadjuvant chemotherapy followed by surgery. Patients aged ?18 years with no history of ipsilateral breast cancer who have clinical stage T1-3 N1 M0 breast cancer at diagnosis and an Eastern Cooperative Oncology Group performance status score of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive axillary lymph node dissection and nodal radiation therapy or axillary radiation and nodal radiation therapy.

The primary outcome measure is the recurrence-free interval of invasive breast cancer. The secondary outcome measures are overall survival and the recurrence of ipsilateral, local, or regional invasive breast cancer. Residual cancer burden will also be measured. This study expects to enroll 2918 patients at multiple locations across the United States.

For more information, contact Judy Boughey, MD, at 507-284-3629. The NLM Identifier is NCT01901094.

16 Early Surgery versus Standard Palliative Treatment for Stage IV Breast Cancer

Researchers in this randomized, phase 3, open-label study are examining how well early surgery works compared with standard palliative therapy in patients with stage IV breast cancer. Patients aged ?18 years with diagnosed, intact, primary, invasive stage IV breast carcinoma who are not pregnant or nursing may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive standard palliative therapy (which may consist of radiotherapy, surgery, or a combination of both) or early surgery comprising breast-conserving therapy or total mastectomy (per patient and physician preference).

The primary outcome measure is overall survival. The secondary outcome measures are uncontrolled chest wall disease and health-related quality of life. This study plans to enroll 880 patients at multiple locations across the United States and abroad.

For more information, contact Seema A. Khan, MD, at 312-503-2112 or the Robert H. Lurie Comprehensive Cancer Center at 312-695-1301 or cancer@northwestern.edu. The NLM Identifier is NCT01242800.

17 Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab with or without Estrogen Deprivation

The purpose of this randomized, open-label, parallel-assignment, phase 3 study is to compare the use of docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in patients with hormone receptor–positive, HER2-positive, operable, or locally advanced breast cancer. Women aged ?18 years with a life expectancy of ?10 years (excluding a diagnosis of breast cancer), an Eastern Cooperative Oncology Group performance status score of 0 or 1, and hemoglobin levels of ?10 g/dL may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive chemotherapy, surgery, and radiation, with or without estrogen deprivation.

The primary outcome measure is to determine the rate of pathologic complete response in the breast and posttherapy lymph nodes. The secondary outcome measures include determining whether adding estrogen deprivation to neoadjuvant therapy consisting of docetaxel, carboplatin, trastuzumab, and pertuzumab improves recurrence-free interval and overall survival, and the effect of adding estrogen deprivation to neoadjuvant therapy on quality of life. This study expects to enroll 212 patients at multiple locations across the United States.

For more information, contact Mothaffar F. Rimawi at 713-798-1354 or burton@bcm.edu. The NLM Identifier is NCT02003209.

18 Letrozole in Postmenopausal Women with Operable Stage I to III Breast Cancer

Investigators in this open-label, single-group assignment study are examining how well letrozole works in the treatment of postmenopausal women with stage I to III breast cancer that can be surgically removed. Women aged ?18 years who have a diagnosis of invasive, resectable stage I to III breast cancer; no severe, uncontrolled malabsorption disease or condition; and who have an Eastern Cooperative Oncology Group performance status score of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive oral letrozole once daily for 7 to 21 days barring evidence of disease progression or unacceptable toxicity. Within a day of their last dose of letrozole, patients will undergo a total mastectomy or segmental resection with lymph node evaluation.

The primary outcome measure is the Ki-67 index in hormone receptor–positive versus hormone receptor–negative breast cancers. The secondary outcome measures are the in situ apoptotic effect of letrozole and the identification of a recurrence risk biomarker profile using ribonucleic acid microarray. This study expects to enroll 200 patients in Nashville, TN.

For more information, contact the Vanderbilt-Ingram Cancer Center Clinical Trials Information Program at 800-811-8480. The NLM Identifier is NCT00651976.

19 Proton Radiotherapy for Partial Breast Irradiation in Early-Stage Breast Cancer

This phase 2, open-label, single-­group assignment study seeks to compare the positive and negative effects of proton radiotherapy on women with early-stage breast cancer. Women aged ?40 years who have a life expectancy of ?5 years (based on age and comorbidities), no history of ipsilateral invasive breast cancer, and who have pathology- proven invasive ductal carcinoma and/or ductal carcinoma in situ may be eligible for enrollment if other criteria are met. Eligible patients will receive proton radiotherapy.

The primary outcome measures are the events of freedom from ipsilateral breast recurrences in patients receiving partial breast proton radiotherapy limited to the tumor region. The secondary outcome measures include quality of life; freedom from failure, survival, and dosimetry of postoperative versus preoperative partial breast irradiation; and the overall survival rate of patients treated with proton radiation. This study plans to enroll 42 patients at centers in Warrenville, IL; Oklahoma City, OK; and Hampton, VA.

For more information, contact Megan Dunn, PhD, at 630-657-0092 or megan.dunn@pcgresearch.org. The NLM Identifier is NCT01766297.

20 Radiation Therapy and Breast-Conserving Surgery in Patients with Multiple Ipsilateral Breast Cancer

The purpose of this phase 2, open-label, single-group assignment study is to examine how well breast-conserving surgery and radiation therapy work as treatments for patients with multiple ipsilateral breast cancer. Women aged ?40 years with a life expectancy of ?5 years (excluding a diagnosis of breast cancer), who do not have clinical or radiographic evidence of metastatic disease, and who have an Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 may be eligible for enrollment if other criteria are met. Eligible patients will undergo breast-­conserving surgery followed by chemotherapy administered within 12 weeks of surgery, and will receive radiation therapy within 8 weeks of their last dose of chemotherapy (or ?10 weeks after surgery if they are not receiving chemotherapy).

The primary outcome measure is to assess the local tumor recurrence rate with breast conservation in patients with multiple ipsilateral breast cancer. The secondary outcome measures include whether patients who did not undergo re-excision for close margins (<2 mm) have a higher local recurrence rate than patients who achieved negative margins, the patient perception of cosmesis, and the incidence of breast lymphedema. This study expects to enroll 230 patients at multiple locations across the United States.

For more information, contact Judy Boughey, MD, at 507-284-3629. The NLM Identifier is NCT01556243.