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Watch an exclusive “Ask the Expert” webinar: “Advancing Breast Cancer Treatment From Trials to Clinical Practice.”
Featuring renowned breast oncologist Dr. Eleonora Teplinsky, Head, Breast and Gynecological Medical Oncology, Valley-Mount Sinai Comprehensive Cancer Care, this session delves into the critical role of clinical trials in transforming breast cancer care, with a special focus on metastatic breast cancer (mBC).
**a summary of the discussion is below**
For patients exploring treatment options, clinical trials often come up as an important avenue, raising questions about how they work and what to expect when participating. This guide offers a high-level overview of clinical trials, the various phases, and their role in advancing cancer care, especially in breast cancer.
What Are Clinical Trials and Their Purpose?
Clinical trials serve as a critical step in developing new treatments and determining their effectiveness. In oncology, trials typically focus on testing new treatments or improving upon existing ones. These studies aim to answer specific questions, such as:
- Is this new treatment more effective than the current standard?
- Does it address quality-of-life issues or side effects better than existing options?
- Is it safe, and what is the ideal dosage?
The Clinical Trial Process: Phases from Research to Approval
Preclinical Research: Before testing in humans, new treatments undergo preclinical studies in labs, often involving cell lines and animal models, to examine preliminary safety and efficacy.
Phase 1 Trials: As the first step in human testing, Phase 1 trials involve a small group of patients and focus on determining the safe dosage and initial safety profile.
Phase 2 Trials: Involving a larger number of patients, Phase 2 trials assess the treatment’s efficacy and begin to provide data on its effectiveness in managing cancer.
Phase 3 Trials: This phase compares the new treatment directly against the current standard of care. These studies determine if the new approach is more effective or offers additional benefits.
FDA Approval and Phase 4 Trials: After Phase 3, if the treatment proves beneficial, it’s submitted to the FDA for approval. Phase 4 trials, or post-marketing studies, may follow, offering insights into long-term effects and how the drug performs outside a controlled study environment.
Clinical Trials for Different Cancer Stages
Clinical trials aren’t just limited to advanced or metastatic cancer. They are conducted at all stages, from early-stage cancer to metastatic disease, providing opportunities to explore treatments that may offer hope at any stage of diagnosis.
Key Takeaway
For patients considering participation, clinical trials represent a structured, phase-by-phase approach to finding safe and effective treatments. Each phase is designed to answer critical questions, from dosage to long-term effectiveness, ultimately aiming to advance the standard of care and offer patients better outcomes.
