PROMISE (MC1634) Protocol News November 2019

Nov 25, 2019

This is a monthly newsletter to update Mayo Clinic affiliated providers as regards the status of the PROMISE study (MC1634), (A Prospective Study to evaluate the role of Tumor Sequencing in Women Receiving Palbociclib for Advanced Hormone Receptor (HR)-Positive, Breast Cancer). We are currently enrolling participants at Mayo Clinic in Rochester, Arizona and Florida.

PROMISE aims to identify somatic and germline alterations associated with early disease progression (<= 12 months) in women with hormone-receptor (HR) positive, HER2-negative breast cancer beginning palbociclib with either letrozole or fulvestrant. Pre-treatment biopsy samples are obtained for whole exome sequencing (germline and tumor), RNA seq (whole transcriptome), and generation of patient derived xenografts and organoids. Fresh and frozen tissue, blood, urine and stool samples are collected for additional correlative studies. The primary objective is to identify novel genomic variants and pathways associated with early progression (<= 12 months) among women with advanced HR-positive breast cancer treated with palbociclib and endocrine therapy, with the goal of identifying mechanisms of endocrine resistance and ultimately developing new drugs for patients with endocrine- resistant breast cancer.Read more.

An important aspect of this study is that blood and tumor sequencing is provided free of charge and the results are communicated to patients and their providers within two months of enrollment. This information may allow you to make personalized treatment decisions for future therapy. Further, patients can follow with their local oncologist, and on study return to Mayo is required only at the restaging intervals. As patients need to undergo a baseline research biopsy, we wish to identify potential participants as soon as possible to avoid the need for re-biopsy and repeat scans when possible (given that many will have staging scans and a baseline, standard-of-care biopsy as part of their workup). Further, if you are referring an interested patient, we would also request that they not be commenced on endocrine therapy or palbociclib in advance of their visit, as this would render them ineligible.

Enrollment Updates:
- 49 patients have been accrued to date across all three Mayo Clinic sites.

Approved Patient Video
To assist with patient information when introducing this study, you have access to a video in which Dr. O'Sullivan explains the trial in lay language.
External YouTube: PROMISE YouTube LINK

Why is the PROMISE study important? Genome-guided care has demonstrated value in precision cancer medicine. The majority of cancer genomics studies focus on only a subset of known genes to determine the right drug for a patient. However, a comprehensive clinical and genomic evaluation of a patient by the interdisciplinary team of scientists and clinicians is critical to address drug-resistant cancers. Our PROMISE study is unique in bringing a team of experts together to generate and analyze comprehensive genomics data from each patient; millions of data points thus analyzed through our predictive analytics workflows are expected to inform biomarkers and molecular mediators of drug resistance in that individual patient. The findings of this personalized genomic analysis will be transferred to our oncologists to facilitate the identification of better treatment options for the patient. The outcomes of this study are expected to positively impact the treatment of our current patients and also lay foundations for identifying effective interventions for our future patients.
What I enjoy doing in my spare time? I like spending time with my family and friends, listening to music, dancing, and traveling. Learning anything new is fun for me, so in my spare time, I also like learning about new analytical methods.
Protocol Questions: Ciara O'Sullivan, MB, BCh, Co-Chair: Contact info is below.


Name Email Phone
Ciara C. O'Sullivan
MB, Bch, Chair, Assist. Professor of Oncology, Mayo Clinic Rochester (507) 293-0526
Matthew P. Goetz
MD, Chair, Professor of Oncology Mayo Clinic Rochester (507) 284-6672
Donald Northfelt
MD, Mayo Clinic-Arizona (408) 301-7755
Alvaro Aspitia
MD, Mayo Clinic-Florida (904) 953-0707

PROMISE Study Champions (MCHS): Sandeep Jain, MBBS; Paula Gill, MD; Mohammad Ranginwala MBBS; Eyad Al-Hattab, MD; Arunabh Sekhri, MBBS; Sameer Batoo, MBBS; Mina Hanna, MD

Study Coordinators:
Location Name Email Phone
Mayo Clinic Rochester Jackie Chonis (507) 284-1887
Mayo Clinic Florida Jessica Schllesinger (904) 953-3643
Mayo Clinic Arizona Isabel Aguilar (480) 342-6042

Project Manager: Jon Harrington, e-mail: ; phone: 507-266-9950

We appreciate receiving questions, comments and feedback on the newsletter via e-mail to Hide this content.

Mayo Clinic Team Science Award for 2019

Aug 29, 2019
Dr. Judy Boughey and Dr. Matthew Goetz and the BEAUTY research team (including Dr Sarah McLaughlin and Dr Richard Gray) have been awarded the Mayo Clinic Team Science Award for 2019. The Breast Cancer Genome Guided Therapy (BEAUTY) team has been working together collaboratively since 2011. BEAUTY was the first study at Mayo Clinic and among the first worldwide to integrate both comprehensive next generation sequencing and creation of patient derived xenografts (PDX) in a prospective clinical trial. BEAUTY enrolled women who received pre-operative chemotherapy for stage I-III breast cancer. Tumor and blood specimens and breast imaging were collected prior to, during, and after completion of chemotherapy (at surgery), and again at time of recurrence. Tumor specimens were sequenced and used for PDX development. The work was funded by Center for Individualized Medicine and BEAUTY collaborations have led or contributed to external grants including a Mayo Clinic-Koch Institute Cancer Solution Team Grant, a U54 grant (Mayo-UIUC), 4 R01 grants, Mayo Clinic Breast Cancer SPORE, DoD grant, and others. The team has published in prominent journals, including Journal of the National Cancer Institute, Journal of Clinical Investigation, Nature Communications, Proceedings of the National Academy of Sciences, Cell Metabolism, and Clinical Cancer Research. BEAUTY has generated 2 patents and provided rationale and led to the novel design of 4 clinical trials. Congratulations!

Genomic Classifier for Luminal Androgen Receptor Triple-Negative Breast Cancer

Jan 25, 2019
By Alice Goodman
TRIPLE-NEGATIVE breast cancer is a heterogeneous disease that comprises several subtypes, which may respond differently to therapy. Breast cancer researchers at the Mayo Clinic are developing a novel genomic signature that may improve the identification of the luminal androgen receptor vs basal (non–luminal androgen receptor) triple-negative breast cancer subtypes, which may better inform treatment selection. [...]

Novel data-driven approach for precision medicine

Nov 12, 2018
By Colette Gallagher @colettegallagher
Dr. Rani Kalari, a computational biologist, and lead author of a Mayo Clinic led study, published in JCO Clinical Cancer Informatics showed that combining multiple sources of data to predict the most effective drug choices for patients with cancer is feasible.[...]

Unlocking the power of genomics data: course offers new tools for discovery

Aug 6, 2018
By Sharon Rosen @sharonhrosen
Mayo Clinic researcher Krishna Rani Kalari, Ph.D., shared how she is applying novel computational approaches to analyze and visualize publically available large-scale cancer genomics data sets. She provided examples of how a researcher or a biologist with limited programming skills could mine multi-omics data with existing bioinformatics tools. She also presented novel omics-guided drug prioritization methods developed by her team. The goal of these algorithms is to identify mutations and dysregulated pathways that are associated with the tumor of an individual patient for personalized treatment.[...]