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.
PROMISE Study Champions (MCHS)
- 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.
Ciara O'Sullivan, MB, BCh, Co-Chair: Contact info is below.
: Sandeep Jain, MBBS; Paula Gill, MD; Mohammad Ranginwala MBBS; Eyad Al-Hattab, MD; Arunabh Sekhri, MBBS; Sameer Batoo, MBBS; Mina Hanna, MD
Jon Harrington, e-mail: Harrington.firstname.lastname@example.org
; phone: 507-266-9950
We appreciate receiving questions, comments and feedback on the newsletter via e-mail to Harrington.email@example.com
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