Comparing a Combination of Drugs for Treatment of HER2-positive Colorectal Cancer as First Line Treatment in the Metastatic Setting
https://www.facingourrisk.org/research-clinical-trials/study/274/treatment-of-her2-positive-colorectal-cancer-as-first-line-treatment-in-the-metastatic-setting
Clinicaltrials.gov identifier:
NCT05253651 (https://clinicaltrials.gov/show/NCT05253651)
Treatment
People with HER2-positive colorectal cancer who have not yet received treatment in the metastatic setting
Study Contact Information:
For additional information, please contact:
Seagen Trial Information Support at (866)333-7436 or clinicaltrials@seagen.com
About the Study
This study is being done to decide if the drug Tukysa (Tucatinib) combined with other cancer drugs works better than the standard of care, which is chemotherapy treatment for people with a specific type of colorectal cancer called HER2 positive colorectal cancer. The study also aims to understand the side effects of the combination of these drugs in treatment.
The combination of drugs being used are Tukysa (Tucatinib), Herceptin (Trastuzumab), and mFOLFOX6, which is a combination of Oxaliplatin, Leucovorin, Levoleucovorin, and Fluorouracil.
What the Study Involves
People in this study will be divided at random into two groups:
Group 1
Patients will receive a combination of treatments.
- Tukysa will be received orally twice a day,
- Herceptin will be injected into the vein (intravenously) on cycle 1 day 1, then every three weeks after,
- and mFOLFOX6 will be given intravenously every 2 weeks.
Group 2
Patients will receive the standard of care treatment. They will receive either:
(1) mFOLFOX6 injected into the vein (intravenously) every 2 weeks,
(2) mFOLFOX6 intravenously every 2 weeks and Avastin (Bevacizumab) intravenously every 2 weeks, or
(3) mFOLFOX6 intravenously every 2 weeks and Erbitux (Cetuximab) intravenously on cycle 1 day 1, followed by another treatment every week.
This Study is Open To:
People 18 years or older who:
- have colorectal or rectal cancer which is metastatic or not able to be removed through surgery who have not yet received treatment in the metastatic setting
- have HER2-positive cancer determined by a tissue-based test
- can provide a sample of your tumor tissue before starting the study
- have cancer able to be measured by XRAY showing that the cancer has progressed in a location that was already treated or an area of cancer that has not previously been treated
- have no evidence of cancer that has spread to the brain
- have previously treated brain metastases that are not causing symptoms
This Study is Not Open To:
People who have:
- received prior treatment for their metastatic colorectal cancer
- received radiation therapy within the 14 days prior to enrollment
- received prior treatment with anti-HER2 therapy
- had a hole that developed through the small or large intestine (GI perforation/damage) within 12 months before starting the trial
- an ongoing Grade 3 or higher neuropathy (damage to the nervous system)
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.