Phase: Phase III
ClinicalTrials.gov ID number: NCT03326674
Sponsor of the trial: Odonate Therapeutics
Who is the trial for?
The CONTESSA trial is for people diagnosed with metastatic, hormone-receptor-positive, HER2-negative breast cancer. The trial is looking to see if tesetaxel, an experimental taxane chemotherapy medicine that is taken orally as a pill, in combination with a lower-than-usual dose of Xeloda (chemical name: capecitabine) is better than the standard dose of Xeloda alone. Xeloda also is taken orally as a pill.
Why the trial is being done
Chemotherapy is commonly used to treat all types of metastatic breast cancer. Research shows that many doctors prefer to use Xeloda and/or a taxane as the first chemotherapy treatment for metastatic, hormone-receptor-positive, HER2-negative breast cancer.
All three of the taxanes currently used to treat breast cancer:
- Abraxane (chemical name: albumin-bound or nab-paclitaxel)
- Taxol (chemical name: paclitaxel)
- Taxotere (chemical name: docetaxel)
are given intravenously. This means that you have to go to an infusion center to receive one of these medicines.
In addition, Taxol and Taxotere use solvents to dissolve paclitaxel, the main ingredient, so the medicine can enter the bloodstream. These solvents may make Taxol and Taxotere difficult to tolerate while being given. People usually take pre-medications to minimize reactions to the solvents. Instead of a solvent, the paclitaxel in Abraxane is suspended in albumin, a protein, which may make it easier to take without the need for pre-medication.
Many, many patients and doctors find medicines in pill form more convenient.
Results from earlier phase I and phase II trials on tesetaxel suggest that the medicine can have the potential to effectively treat metastatic breast cancer.
The CONTESSA trail is looking to see if tesetaxel plus a lower-than-usual dose of Xeloda will increase progression free survival and cause fewer side effects than the standard dose of Xeloda alone in people diagnosed with metastatic, hormone-receptor-positive, HER2-negative breast cancer.
Progression-free survival is how long a person lives without the cancer growing.
Specific eligibility requirements
People are eligible to participate in the CONTESSA trial if they:
- have been diagnosed with hormone-receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
- were treated with a taxane before or after breast cancer surgery for an earlier stage of breast cancer
- were treated with any number of hormonal therapy medicines
- were treated with any number of targeted therapy medicines, such as Ibrance (chemical name: palbociclib) or Afinitor (chemical name: everolimus)
- have received no chemotherapy to treat the locally advanced or metastatic disease
OR received one chemotherapy regimen that did not include a taxane or Xeloda to treat the locally advanced or metastatic disease
People are NOT eligible for the CONTESSA trial if they:
- have been diagnosed with HER2-positive or hormone-receptor-negative breast cancer
- were not treated with a taxane before or after breast cancer surgery for an earlier stage of breast cancer
- were diagnosed with de novo locally advanced or metastatic breast cancer; de novo means the cancer was locally advanced or metastatic at first diagnosis
- were previously treated with a taxane for locally advanced or metastatic breast cancer
- were previously treated with Xeloda
Potential side effects of the treatment being studied
In earlier studies, among the potential side effects, tesetaxel use resulted in:
- neutropenia: low counts of a specific type of white blood cell
- neuropathy: pain, tingling, and numbness in the hands and feet caused by nerve damage
Study locations: The CONTESSA study is being conducted at multiple sites around the world, including in the United States, the United Kingdom, Australia, France, Germany, Italy, Spain, and Russia. For the complete list of sites, visit the CONTESSA study website.
For more information or to enroll
Visit the CONTESSA trial website: https://www.contessastudy.com/.