Breast Cancer

Disease Group

Breast Cancer

Disease Group Profile

The ACCRU breast cancer disease group is co-led by Dr. Matthew Goetz and Dr. Dan Flora. Dr. Goetz is a consultant in the Division of Medical Oncology, Department of Oncology, at Mayo Clinic in Rochester, Minnesota and holds the academic rank of Professor of Oncology and Pharmacology, Mayo Clinic College of Medicine and Science where he is the Erivan K. Haub Family Professor in Cancer Research Honoring Richard F. Emslander, M.D. Dr. Goetz leads breast cancer research at Mayo Clinic where he is co-chair of the Mayo Breast Cancer Disease Group, co-leader of the Women’s Cancer Program within the Mayo Clinic Cancer Center, and Director of the Mayo Breast Cancer SPORE. Dr. Goetz has been extensively involved in both translational research as well as in the conduct of early- and late-phase clinical trials, with a focus on the development of new endocrine approaches for the treatment of ER+/HER2 negative breast cancer. In addition to his clinical and research roles, Dr. Goetz is active in professional organizations. He currently serves on the steering committees for the NCI Breast Cancer Steering Committee, the Translational Breast Cancer Research Consortium, and the Early Breast Cancer Trialists’ Collaborative Group.

The ACCRU Breast Cancer Disease group is made up of academic and community breast cancer leaders from across the U.S. and the overall goal of the ACCRU Breast Disease group is to develop novel investigator initiated and industry trials with the goal of reducing the morbidity and mortality from breast cancer.

Currently, the ACCRU Breast Disease group has ongoing DOD sponsored clinical trials testing new vaccine approaches for the adjuvant treatment of TNBC and HER2+ breast cancer. Additionally trials are in development in the metastatic setting focusing on using ctDNA approaches to treat TNBC, as well as a new drug for the neoadjuvant treatment of premenopausal ER+HER2 negative breast cancer (Z-endoxifen).

Disease Group Leaders

Matthew Goetz, M.D.

ACCRU Vice-ChairMayo Clinic Rochester

Matthew Goetz, M.D. has been an ACCRU member since 2011 where he co-leads the ACCRU Breast Disease Group along with Dr. Dan Flora. Dr. Goetz was recently appointed as ACCRU Vice-Chair and he is a member of the ACCRU Executive Committee where he is responsible for strategic planning and oversight for the scientific activities of ACCRU.

Daniel Flora, M.D., Pharm D

Saint Elizabeth Hospital

Daniel Flora, M.D. is a Medical Oncologist at St. Elizabeth Healthcare in Kentucky. With a background in pharmacology, Dr. Flora has a special interest in “personalized medicine,” in which each individual’s treatment plan is developed to minimize toxicity. He is currently leading the St. Elizabeth Oncology research team as principal investigator for multiple clinical trials. Many of these studies are exploring alternatives to chemotherapy, such as targeted or immune therapies. Dr. Flora is the recipient of the Arnold P. Gold Humanism in Medicine Award and the Cancer Family Care Unsung Heroes Award.

Disease Group Clinical Trials

D8532C00001

A Randomised, Multicentre, Double-Blind, Phase 3 Study of AZD9833 (An Oral SERD) plus Palbociclib plus Anastrozole Placebo versus Anastrozole plus Palbociclib plus AZD9833 Placebo for the treatment of Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer who have not received any systemic treatment for advanced disease.

RU011501I

Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination with Folate Receptor Alpha Peptide Vaccine with GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients with Triple Negative Breast Cancer

Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer »

ATOS-Z-201

A Randomized Phase 2 Non-inferiority Trial of (Z) – endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment for Premenopausal Women with ER+/HER2-Breast Cancer

11-PIR-11

The BEACON Study (Breast Cancer Outcomes With NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician’s Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine

The BEACON Study (Breast Cancer Outcomes With NKTR-102) (BEACON) »

ABI-007-MBC-001

A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) (tnAcity) »

BO25126

A Randomized Multicenter, Double-blind, Placebo-controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-positive Primary Breast Cancer

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (APHINITY) »

D0819C00003

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (OlympiAD) »

MC05C8

Zoledronic Acid for Treatment of Osteopenia and Osteoporosis in Women With Primary Breast Cancer Undergoing Adjuvant Aromatase Inhibitor (Letrozole) Therapy

Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer »

MC1835-ACCRU-BR-1701

Phase II trial to evaluate immune-related biomarkers for pathological response in stage II-III HER2-positive breast cancer receiving neoadjuvant chemotherapy with subsequent randomization to multi-epitope HER2 vaccine vs. placebo in patients with residual disease post-neoadjuvant chemotherapy.

RC0639

Phase II Study of Cardiac Safety and Tolerability of an Adjuvant Chemotherapy Plus Trastuzumab With Lapatinib in Patients With Resected HER2 Breast Cancer

Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery »

RC0731

Phase II Randomized Study of Sorafenib Compared to Placebo When Administered in Combination With Aromatase Inhibitors for Postmenopausal Women With Metastatic Breast Cancer

Sorafenib and Letrozole, Anastrozole, or Exemestane in Treating Postmenopausal Women With Estrogen Receptor-Positive and/or Progesterone Receptor-Positive Metastatic Breast Cancer »

RU011201I

A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Eribulin Mesylate or Paclitaxel as First- or Second-Line Therapy in Treating Patients With Recurrent Stage IIIC-IV Breast Cancer »