Phase: Phase III
ClinicalTrials.gov ID number: NCT03975647
Sponsor of the trial: Seattle Genetics, Inc.
Who is the trial for?
The HER2CLIMB-02 trial is currently enrolling people diagnosed with metastatic HER2-positive breast cancer or locally advanced HER2-positive disease that can’t be completely removed with surgery. The cancer must have previously been treated with Herceptin (chemical name: trastuzumab) and a taxane chemotherapy.
Taxane chemotherapy medicines are:
- Taxol (chemical name: paclitaxel)
- Abraxane (chemical name: albumin-bound or nab-paclitaxel)
Doctors call cancer that can’t be completely removed with surgery unresectable. Locally advanced breast cancer is breast cancer that has spread to tissue near the breast, but not to parts of the body away from the breast. Metastatic breast cancer is breast cancer that has spread to parts of the body away from the breast, such as the bones or liver.
Why the trial is being done
Tukysa (chemical name: tucatinib) is a tyrosine kinase inhibitor. Tyrosine kinases are enzymes that help control how cells grow and divide, among other functions. If the enzyme is too active or if a cell has too much of the enzyme, it can make cells grow uncontrollably. Tukysa blocks a specific area of the HER2 gene in HER2-positive cancer cells, which stops the cells from growing and spreading.
HER2CLIMB-02 is a trial looking to see if Tukysa given in combination with Kadcyla offers better progression-free survival than Kadcyla alone in people previously treated with Herceptin and a taxane. Progression-free survival is how long a person lives without the cancer growing.
Tukysa is a pill taken by mouth. Kadcyla is given intravenously, which means the medicine is delivered directly into your bloodstream through an IV or port.
HER2CLIMB-02 is a double-blind placebo-controlled trial. Placebo-controlled means people in the trial will receive either Tukysa or placebo (a dummy pill that looks just like Tukysa). All participants will receive Kadcyla. Double-blind means that neither you, your doctor, nor the study team will know which treatment you have been assigned to receive.
In the HER2CLIMB-02 trial, each study treatment cycle is 21 days. People will take either Tukysa or a placebo twice per day for the entire 21-day cycle. On the first day of each 21-day cycle, people will get an infusion of Kadcyla. Cycles will continue until a person’s cancer worsens, a person experiences a side effect that requires study treatment to stop, or they decide they no longer want to participate in the trial.
Specific eligibility requirements
People are eligible for the HER2CLIMB-02 trial if they:
- Are 18 years and older and have been diagnosed with HER2-positive breast cancer that has come back after treatment or has spread to parts of the body away from the breast.
- Have been previously treated with Herceptin and a taxane.
It’s important to know that people who have brain metastases (breast cancer that has spread to the brain) may be eligible for the HER2CLIMB-02 trial.
People are not eligible for the HER2CLIMB-02 trial if they:
- have previously been treated with Kadcyla
- have a history of significant lung or heart disease
- are pregnant, breastfeeding, or plan to become pregnant during the study or 7 months after the last dose medicine during the study
Potential side effects of the treatment being studied
In earlier studies, side effects of Tukysa in combination with Kadcyla were:
- low platelet counts
- low blood potassium levels
- high liver enzyme levels
- loss of appetite
- dry mouth
- urinary tract infection
- joint pain
The HER2CLIMB-02 trial is being conducted at multiple sites around the world and the United States. For a complete list of sites, visit www.her2climb.com.
For more information on detailed eligibility requirements or to enroll
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