Pilot

Study Title: Pilot Trial of an Implantable Microdevice for in Vivo Drug Sensitivity Testing in Patients With Early-Stage, HER2-Positive, or Triple-Negative Breast Cancer Receiving Neoadjuvant Therapy

Study Type: Pilot/interventional/single-group assignment

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center

Purpose: To test the safety and feasibility of placing and removing a small device that contains anticancer drugs in a breast tumor before patients receive standard preoperative chemotherapy. This device may be able to predict what types of treatment work best against an individual’s breast cancer. With this device, the investigators hope to be able to personalize treatment choices based on an individual’s type of breast cancer.

Primary Outcome Measures: Number of implantable devices [time frame: 1 year]

Principal Investigator: Tiffany Traina, MD, Memorial Sloan Kettering Cancer Center; (646) 888-5209

ClinicalTrials.gov Identifier: NCT02521363

Phase I/II

Study Title: Randomized Phase II Study of Partial-Breast Irradiation and Sequential vs Concurrent Chemotherapy in Women With Early-Stage Breast Cancer

Study Type: Phase I/II/interventional/parallel assignment

Study Sponsor and Collaborators: Indiana University

Purpose: To determine whether giving partial-breast irradiation and chemotherapy at the same time has the same side effects and outcomes as giving partial-breast irradiation and chemotherapy at different times

Primary Outcome Measures: Grade 3 or 4 short-term toxicity [time frame: 6–7-month follow-up]

Principal Investigator: Richard Zellars, MD, Indiana University School of Medicine/Simon Cancer Center; contact Jill Deluca, (317) 944-1189, jdelucca@iupui.edu

ClinicalTrials.gov Identifier: NCT01928589

Phase II

Study Title: Evaluating Mass Spectrometry and Intraoperative MRI in the Advanced Multimodality Image-Guided Operating Suite (Amigo) in Breast-Conserving Therapy

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: Dana-Farber Cancer Institute

Purpose: To investigate the use of intraoperative magnetic resonance imaging (MRI) and mass spectrometry during breast-conserving surgery and to determine whether these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins

Primary Outcome Measures: To evaluate the accuracy of MRI in detecting tumor boundaries [time frame: 2 years]

Principal Investigator: Mehra Golshan, MD, Dana-Farber Cancer Institute; (617) 632-3529, mgolshan@partners.org

ClinicalTrials.gov Identifier: NCT02335671

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Study Title: Phase II Protocol of Proton Therapy for Partial-Breast Irradiation in Early-Stage Breast Cancer

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: Proton Collaborative Group

Purpose: To determine whether proton radiation therapy will prove to be beneficial for women with early-stage breast cancer

Primary Outcome Measures: To assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial-breast proton radiation therapy limited to the region of the tumor [time frame: at 3 years]

Principal Investigator: Andrew Chang, MD, Proton Collaborative Group; contact Corey Woods, RN, MS, CCRC (630) 836-8668, cwoods@pcgresearch.org

ClinicalTrials.gov Identifier: NCT01766297

Phase III

Study Title: Palbociclib Collaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy vs Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor–Positive/HER2-Negative Early Breast Cancer

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: Alliance Foundation Trials, LLC; Austrian Breast & Colorectal Cancer Study Group; NSABP Foundation Inc; PrECOG, LLC; Breast International Group

Purpose: To determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for hormone receptor–positive/HER2-negative early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.

Primary Outcome Measures: Invasive disease–free survival [time frame: 4.8 years]

Principal Investigator: Monica Bertagnolli, MD, Alliance Foundation Trials LLC; pallas_aft@alliancefoundationtrials.org

ClinicalTrials.gov Identifier: NCT02513394

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Study Title: Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women With Early-Stage Breast Cancer

Study Type: Phase III/interventional/randomized

Study Sponsor and Collaborators: Southwest Oncology Group, National Cancer Institute, National Center for Complementary and Integrative Health

Purpose: To study acupuncture to see how well it works compared with sham acupuncture or waitlist in treating patients with joint pain related to aromatase inhibitors in patients with early-stage breast cancer

Primary Outcome Measures: Decrease of joint pain associated with the use of aromatase inhibitors as measured by the Brief Pain Inventory-Short Form [time frame: 6 weeks]

Principal Investigator: Dawn Hershman, Herbert Irving Comprehensive Cancer Center; contact Kimberly Kaberle; (210) 614-8808 ext 1022, kkaberle@swog.org

ClinicalTrials.gov Identifier: NCT01535066 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.