At left, clinical trial nurse Leighanne Hartman has a white labcoat and mask on. Elle Charnisky in a baseball cap and t-shirt is showing her photos while receiving a chemotherapy infusion.
Leighanne Hartman, MSN, RN, AGNP-C, CHPN, CCRC, the clinical research nurse assigned to the MOUNTAINEER trial on day one (2017) made a special trip to see Elle at her infusion appointment on June 10, 2021. It had been over two years since they’d last seen each other and they had a lot to catch up on — new dogs, growing kids, and summer plans. For Hartman, the experience of working on MOUNTAINEER for two years and meeting Elle inspired a career change. In 2019, she went back to school to earn nurse practitioner certification so she could engage with more hands-on patient care.“Upon first meeting Elle, she gave off such a positive attitude, exuding optimism, while calling on her faith to sustain her. I was in awe of Elle’s determination to live her life, resolute in finding a treatment to prolong her life and put her cancer in remission,” said Hartman, who now works on Unit 9300, an inpatient unit for critically ill cancer patients.

Mountaineer: A Homegrown Story of Survival & Promise


Global biotech company Seagen Inc. announced positive topline results last month of a pivotal phase 2 clinical trial (called MOUNTAINEER) of tucatinib in combination with trastuzumab in HER2-positive metastatic colorectal cancer. Both drugs are used in breast cancer, a type of cancer where HER2 amplification is common. HER2 amplification is uncommon, however, in colorectal cancer.

The idea to test these drugs in HER2-positive colorectal cancer patients was initiated by Duke Cancer Institute GI oncologist and co-leader of DCI's Precision Cancer Medicine and Investigational Therapeutics Research Program, John Strickler, MD, who first reached out to Seagen (then Cascadian Therapeutics and the maker of tucatinib) around 2015.

On August 8, 2017, the first patient nationwide to be accrued — Elle Charnisky — began the trial at DCI.

Now a 5-year metastatic colorectal cancer survivor, Charnisky is still going strong and most recently shared her story at the DCI 50th Anniversary celebration held on April 14, 2022.

Strickler will present the full data at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona, Spain — to be held June 29 through July 2, 2022. According to Seagen, "data from this trial will form the basis of a planned supplemental New Drug Application to the FDA under the FDA’s Accelerated Approval Program."

UPDATE (January 19, 2023): FDA Approval

Associate Professor of Medicine and GI oncologist John Strickler, MD, and team's milestone work on the clinical trial "MOUNTAINEER" has led to the first FDA-approved treatment regimen for patients with HER2+ metastatic colorectal cancer. Tucatinib (Tukysa, Seagen Inc.), in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, was granted accelerated approval.

Strickler is co-leader of DCI's Precision Cancer Medicine and Investigational Therapeutics Research Program.

READ MORE about Elle's Journey and the History of Mountaineer

Elle Charnisky wears a ponytail and a blue cap with 'Survivor' printed on the back of her t-shirt stand in a rooftop garden overlooking Duke campus.
SURVIVOR Colorectal cancer survivor Elle Charnisky, 41, finds respite in the Bernstein Family Garden. The rooftop garden is accessible from the Oncology Treatment Center waiting room (Duke Cancer Center Level 4, June 10, 2021, photo by Julie Poucher Harbin)

In 2017, Elle Charnisky, then a 37-year-old mother of two children under five, had 7 months to live. She was nearly out of options.

HERstory: Young Mom with Rectal Cancer Gets a Third Chance
Seven DCI Team Members in scrubs and labcoats stand with Elle Charnisky on stage in front of a DCI 50th Anniversary banner.
Elle Charnisky (in a black & white shirt at center) and her care team celebrate her survival at Duke Cancer Institute's 50th Anniversary commemoration, held on the lawn of Duke Cancer Center on April 14, 2022. (photo by Drawbridge Media)

In Her Own Words, April 2022

"When we sat down in the office of Dr. John Strickler, who is truly one in a million, we had a sense that our lives were never going to be the same... "

At DCI 50th, the Sounds of Hope
This page was reviewed on 07/27/2022 by