Current Open Cancer Clinical Trials

Researchers at New England Hematology/Oncology and Dana-Farber Cancer Institute are collaborating on a variety of studies that examine cancer in many different medical areas. Below is a list of clinical trials currently enrolling subjects.
(last updated May 2014)

Breast Cancer

A randomized phase III trial of the value of early local therapy for the intact primary tumor in patients with metastatic breast cancer
The aim of this study is to compare the possible benefits as well as the potential risks of a new approach that includes surgery and radiation to treat the tumor in the breast in addition to medication, versus the current standard approach (ie, medication to control the cancer that has spread).

A phase III randomized clinical trial of standard adjuvant endocrine therapy +/- chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and HER-2-negative breast cancer with recurrence score (RS) of 25 or less
The aim of this study is to determine whether the results from the Oncotype DX test can help determine who would benefit from chemotherapy and endocrine therapy and who would benefit from endocrine therapy alone.

A phase III clinical trial comparing trastuzumab given concurrently with radiation therapy and radiation therapy alone for women with HER-2-positive DCIS resected by lumpectomy
The aim of this study is to determine whether giving trastuzumab during radiation treatments is more beneficial in preventing breast cancer recurrence when compared with radiation treatments alone in women with HER-2-positive ductal carcinoma in situ (DCIS) resected by lumpectomy.

A three-arm, randomized, open label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole
The purpose of the study is to compare the combination treatment of everolimus and exemestane to either everolimus alone, or capecitabine alone and to determine which of these three drugs, alone or in combination, better stabilizes or stops progression of breast cancer.

Helping ourselves, helping others: the young women’s breast cancer study
The aim of this study is to learn more about how breast cancer in young women affects their lives. We are particularly interested in young women’s emotional well-being, fertility concerns, sexual functioning, and physical health and treatment decisions.

Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy +/- one year of everolimus in patients with high-risk, hormone receptor-positive and HER2/neu negative breast cancer
The aim of this study is to compare whether the addition of one year of everolimus to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer. 

A randomized phase III trial of adjuvant therapy comparing chemo alone (6 cycles of tc or 4 cycles of ac->weekly t) to chemotherapy plus trastuzumab in women with n+ or high-risk n0 HER2-low invasive breast cancer
The aim of this study is to determine whether the addition of trastuzumab to chemotherapy improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.

Randomized double-blind placebo controlled study of subcutaneous testosterone in the adjuvant treatment of postmenopausal women with aromatase inhibitor induced arthralgias
The aim of this study is to determine whether testosterone will reduce aromatase inhibitor-induced arthralgia and associated joint symptoms.

Breast and Ovarian Cancer

Genetic and other causes of cancer. Risk evaluation and cancer history (REACH) questionnaire.
The REACH project collects risk factor information, blood and tissue specimens from patients and family members at high risk for breast and/or ovarian cancer. The data and specimen bank will be used as a resource to be shared with researchers working in the areas of breast and ovarian cancer risk, prevention and treatment.

Colon Cancer

A phase III trial of 6 versus 12 treatments of adjuvant folfox plus celecoxib or placebo for participants with resected stage III colon cancer
One of the purposes of this study is to determine if giving participants both celecoxib (by mouth) and chemotherapy decreases the risk of colon cancer recurrence. The second purpose of this study is to determine whether giving 6 treatments of chemotherapy after surgery is as effective as giving the standard 12 treatments of chemotherapy.

Randomized, double-blind, phase II trial of vitamin d supplementation in patients with previously untreated metastatic colorectal cancer
The aim of this study is to to evaluate the efficacy and safety of two doses of vitamin D supplementation in combination with standard chemotherapy in participants with previously-untreated metastatic colorectal adenocarcinoma. Standard treatment includes the chemotherapy combination of 5-FU, Leucovorin and Oxaliplatin (FOLFOX) with bevacizumab.


A randomized phase III study of bendamustine plus rituximab versus ibrutinib plus rituximab versus ibrutinib alone in untreated older patients (≥ 65 years of age) with chronic lymphocytic leukemia (CLL)
The aim of this study is to determine whether progression free survival (PFS) is superior after therapy with bendamustine in combination with rituximab, ibrutinib alone, or ibrutinib in combination with rituximab in patients age 65 or older with previously untreated CLL.


A phase I/II study of the alk inhibitor ch5424802/ ro5424802 in patients with alk-rearranged NSCLC previously treated with chemotherapy and crizotinib
The aim of this study is to determine the response rate of ch5424802/ ro5424802 in patients with locally advanced or metastatic alk-positive NSCLC who have failed crizotinib treatment.

Randomized phase III study of maintenance therapy with bevacizumab, pemetrexed, or a combination of bevacizumab and pemetrexed following carboplatin, paclitaxel and bevacizumab for advanced non-squamous NSCLC
the aim of this study is to compare the overall survival associated with maintenance therapy with bevacizumab, pemetrexed or the combination in patients with advanced stage NSCLC.


Phase I/II trial of combination plerixafor (amd3100) bortezomib and dexamethasone in relapsed or relapsed/refractory multiple myeloma
The aim of this clinical trial is to determine how effective the combination of plerixafor, bortezomib and dexamethasone is on stopping myeloma cells from growing in patients who have relapsed or refractory myeloma.

A randomized, phase III study comparing conventional dose treatment using a combination of lenalidomide, bortezomib and dexamethasone (RVD) to high-dose treatment with peripheral stem cell transplant in the initial management of myeloma in patients up to 65 years of age
The aim of this research study is to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma.

Prostate Cancer

Phase III trial of enzalutamide (nsc # 766085) versus enzalutamide, abiraterone and prednisone for castration resistant metastatic prostate cancer
The aim of this study is to compare the overall survival of patients with progressive metastatic castration resistant prostate cancer treated with either a) enzalutamide only or b) enzalutamide with abiraterone and prednisone.


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