New Clinical Trials Under Way

The following clinical trials are currently recruiting participants with breast cancer for inclusion. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

Akt Inhibitor MK-2206 and Anastrozole with or Without Goserelin Acetate
The goal of this phase 2, open-label, single-arm clinical trial is to assess the efficacy of the Akt inhibitor MK-2206 and anastrozole with or without goserelin acetate in treating patients with stage II to stage III breast cancer. Female patients aged ≥18 years with estrogen-receptor–positive, HER2-neu, recurrent, stage II, IIIA, IIIB, or IIIC breast cancer are eligible to participate in this study. Serum estradiol levels, apoptotic index, and Ki-67 level biomarker analyses are conducted.

All patients receive oral MK-2206 on days 2, 9, 16, and 23, and oral anastrozole daily on days 1 to 28. Premenopausal patients receive goserelin acetate subcutaneous injection on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Other procedures include neoadjuvant therapy and therapeutic conventional therapy. The primary outcome is the pathological complete response based on tumor Ki-67 value at a 90% confidence interval. Secondary outcomes include clinical and radiological response rate and incidence of adverse events. This clinical trial is expected to enroll 87 patients and will be conducted at multiple sites throughout the United States.

For more information, contact Cynthia Ma, MD, PhD, at 314-362-9383 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01776008.




Veliparib and Carboplatin in Patients with HER2-Negative Metastatic Breast Cancer
In this phase 1, dose-escalation, open-label, single-group assignment study, investigators are evaluating the optimal dose of veliparib when given together with carboplatin in patients with metastatic HER2-neu breast cancer. Patients aged ≥18 years with histologically or cytologically confirmed metastatic or locally advanced inoperable breast cancer are eligible to participate in this clinical trial. All patients receive intravenous carboplatin for 1 hour on day 1 and veliparib orally twice daily on days 1 to 7 or on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may undergo fluorothymidine positron emission tomography scan and peripheral blood cell and tumor tissue collection periodically for correlative studies.

The primary objective of this clinical trial is to assess the safety, tolerability, and preliminary efficacy of this drug combination. The secondary objectives are to determine the pharmacodynamic end points of poly ADP-ribose polymerase (PARP) inhibition in the tumor and to determine the biomarkers in the primary tumor that may predict antitumor responses to PARP inhibition, such as breast cancer 1/2, early-onset protein, Fanconi anemia complementation group D2, nuclear foci formation, and expression of micro-­ribonucleic acid 155. Data will be collected from a 12-week follow-up period posttreatment. This clinical trial will enroll an estimated 42 patients between Montefiore Medical Center in New York and Ohio State University Medical Center.

For more information, contact Joseph A. Sparano, MD, at 718-904-2555 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01251874.




Enzalutamide for Advanced, Androgen Receptor–Positive, Triple-Negative Breast Cancer
The purpose of this phase 2 study is to determine whether enzalutamide is safe and effective in the treatment of women aged ≥18 years with advanced breast cancer that expresses only the androgen receptor. The single arm will receive enzalutamide 160 mg administered once daily as 4 soft oral gelatin capsules. The clinical benefit rate is measured at ≥16 weeks for the primary outcome and at ≥24 weeks for the secondary outcome, defined as the proportion of evaluable patients with androgen receptor–positive, triple-negative breast cancer with a best response of complete response, partial response, or stable disease. Other outcome measures include overall survival and androgen expression at ≥16 weeks. This clinical trial will enroll an estimated 95 patients and will be conducted at multiple sites across the United States.

For more information, contact Amy Peterson, MD, at 415-543-3470 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01889238.




NeuVax Vaccine to Prevent Breast Cancer Recurrence (PRESENT)
The goal of this phase 3, randomized, double-blind study is to compare disease-free survival in patients with operable early-stage, node-positive breast cancer who receive standard-of-care multimodality therapy plus nelipepimut-S (NeuVax) vaccine as the treatment group or standard-of-care multimodality therapy plus the vaccine adjuvant sargramostim (Leukine) as the control group. The secondary outcome measures include disease-free survival and overall survival at 3, 5, and 10 years in the vaccine and control groups.

Female patients aged ≥18 years with invasive adenocarcinoma are eligible to participate in this clinical trial if they previously received chemotherapy or surgery treatment to excise the cancer. Other inclusion criteria include node-positive disease, primary tumor stage T1-T3 at initial diagnosis, and HER2-neu breast cancer. Assessments are performed at every study visit for the safety end points, adverse events, vital signs, physical examinations, and laboratory data. Yearly follow-up of survival will include imaging studies, cardiac scans, and concomitant medications. There is an estimated enrollment of 700 patients with trial locations throughout the United States.

For more information, contact Elizabeth A. Mittendorf, MD, PhD, FACS, at 713-792-2362 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01479244.




BKM120 with Paclitaxel in Patients with HER2-Negative, Locally Advanced, or Metastatic Breast Cancer
In this randomized, phase 2/3, double-blind study, investigators are evaluating whether the addition of daily BKM120 to weekly paclitaxel is safe and effective in treating patients with HER2-neu locally advanced or metastatic breast cancer. Female patients aged ≥18 years with adequate bone marrow and organ function are eligible to participate in this clinical trial. PI3K biomarker activation status is collected before enrollment. The experimental arm will receive BKM120 oral capsules 100-mg daily and paclitaxel injection 80 mg/m2 weekly, and the comparator arm will receive matching placebo and paclitaxel at the same dose. Treatment will continue until disease progression or as described in the protocol.

The primary outcome of this clinical trial is progression-free survival every 8 weeks after randomization. Secondary outcomes include overall survival and response rate, duration and time to response, clinical benefit rate, and time to definitive deterioration of Eastern Cooperative Oncology Group performance status. The type, frequency, and severity of adverse events are monitored until 30 days posttreatment. This clinical trial will enroll an estimated 524 patients and will be conducted at multiple locations across the United States.

For more information, contact Novartis Pharmaceuticals at 888-669-6682. The NLM Identifier is NCT01572727.




Fulvestrant and/or Anastrozole in Postmenopausal Patients
This phase 3, randomized, open-label clinical trial has 2 primary objectives: (1) to compare the efficacy of fulvestrant and anastrozole, either alone or in combination for 6 cycles in reducing cancer growth before surgery; and (2) to evaluate whether patients who achieved a modified Preoperative Endocrine Prognostic Index score of 0 at surgery after 6 months of neoadjuvant endocrine therapy predict excellent long-term outcome.

This clinical trial enrolls postmenopausal women with Eastern Cooperative Oncology Group performance status of 0-2 with clinical T2-T4c, any N, M0 invasive stage II to stage III breast cancer. The primary outcome measures of this clinical trial include rate of endocrine-resistant disease, recurrence-free survival (postsurgery phase), and pathological complete response rate. This study will enroll an estimated 2820 patients and will be conducted at numerous locations across the United States.

For more information, contact Cynthia Ma, MD, PhD, at 314-362-9383 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01953588.




Lapatinib Ditosylate and Radiation Therapy in Patients with Locally Advanced or Locally Recurrent Breast Cancer
The objective of this phase 2, open-label clinical trial is to assess the clinical complete response rate after concurrent lapatinib ditosylate and radiotherapy in patients with locally advanced or locally recurrent breast cancer that is refractory to chemotherapy. All patients aged ≥18 years with histologically or cytologically confirmed locally advanced breast cancer with new evidence of a local recurrence, life expectancy of >3 months, and other inclusion criteria are eligible for enrollment.

Patients receive lapatinib ditosylate orally once daily on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5 to 7 weeks. After completion of study treatment, patients are followed up at 2 to 4 weeks and at 6 to 12 weeks. Other outcomes include determining the feasibility of using flow cytometry and single-cell gene expression profiling to assess breast cancer stem cells and their change in proportion after combined modality therapy. This clinical trial will enroll an estimated 22 patients and will be conducted at Stanford University Cancer Institute in California.

For additional information, contact Amanda Simmons at 650-724-4606 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01868503.

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