OPTIMA Trial: A New Approach to Breast Cancer Treatment
Chemotherapy followed by hormone therapy is a common treatment strategy after surgery for breast cancer, aimed at reducing the risk of recurrence. However, not all patients benefit from chemotherapy, prompting the need for more precise treatment selection methods.
The Role of the Prosigna Test
The Prosigna test represents a significant advancement in personalized medicine for breast cancer. By analyzing the activity of 50 genes in cancer tissue samples, it offers insights into which patients are likely to benefit from chemotherapy. This approach could spare some patients from the side effects of unnecessary chemotherapy.
Trial Design and Participation
The OPTIMA trial is structured in two stages:
- Pilot Trial: Involved 412 participants to assess the feasibility of using the Prosigna test.
- Phase 3 Trial: Aims to enroll 4,500 participants to evaluate the effectiveness and safety of treatment decisions guided by the Prosigna test.
Participants are randomly assigned to one of two groups:
- Group 1: Receives standard treatment without the Prosigna test.
- Group 2: Treatment decisions are informed by the Prosigna test, potentially leading to chemotherapy followed by hormone therapy or hormone therapy alone.
Treatment and Monitoring
Patients in both groups receive chemotherapy as an intravenous drip and hormone therapy in the form of daily tablets. For premenopausal women, monthly injections may be recommended to enhance hormone treatment effectiveness. The trial also monitors bone health, offering checkpoint inhibitors like abemaciclib if necessary.
Quality of Life Study
An integral part of the OPTIMA trial is the assessment of patients' quality of life. Participants complete questionnaires at various intervals to report on side effects and overall well-being, providing valuable data on the long-term impacts of treatment.
This trial underscores the importance of personalized medicine in breast cancer treatment, offering hope for more effective and less invasive care options for patients.
