What is a clinical trial?
A clinical trial is a study required for all new medicines to help us understand whether an investigational medication is safe and effective for humans.
There are usually several phases of clinical trials; each designed to provide more information on the investigational medication effects. When a study is in an early phase (often called Phase 1 or 1b), the clinical trial may involve very few patients. As more is learned about the investigational medication, the size of its studies will typically grow. Later-phase studies (often called Phase 2 and 3) may involve hundreds or thousands of participants.
All clinical trials must follow a strict set of rules that are outlined in the study's protocol. These rules set specific requirements on which types of patients can be included in the study and the procedures that must be followed. Because of these rules, it is important that patients who participate carefully adhere to the visit schedule and the instructions of the research personnel who are conducting the trials.
Why are clinical trials conducted?
Clinical trials are conducted to answer research questions about new medicines and to learn if the investigational medication is safe and effective for humans. The main questions the researchers want to answer are:
- Does this treatment work?
- Does it work better than current treatment options?
- Does the treatment cause side effects?
- Do the benefits of the treatment outweigh the side effects and risks?
- Which patients are most likely to find this treatment helpful?
Why should I participate in a clinical trial?
Participating in a clinical trial is a voluntary opportunity, so it is up to you to decide if you would like to become involved.
Many people with serious diseases participate in clinical trials for these reasons:
- There is no currently approved treatment for their disease;
- They have not experienced improvements in their condition after using the currently approved treatments;
- They want access to a new type of treatment, even if it is not guaranteed to be as good as or better than available treatments;
- They want to contribute to the development of a new treatment for others with a similar disease.
Am I guaranteed to receive the investigational medication if I participate in a research study?
Some studies guarantee the investigational medication to every patient, while other studies may use an approach where only some of the patients receive the investigational medication.
This study is an open label trial, and all patients enrolled in this study will receive at least "standard of care" chemotherapy. Standard of care means that you would receive the same chemotherapy for your cancer, as if you did not participate in the study. Some patients will add treatment with the investigational medication to standard of care chemotherapy. Not all patients will receive the investigational treatment. You and your doctors will know if you receive the investigational treatment.
What is involved in G1's study for TNBC?
We are evaluating an investigational medication for the treatment of patients with locally recurrent or metastatic Triple Negative Breast Cancer (TNBC). If you have been diagnosed with a local recurrence or Stage IV metastatic Triple Negative Breast Cancer, you may be eligible to participate.
Prior to enrolling in the study, it is important to talk to your doctor and the study's staff and to read the Informed Consent Form, so you are aware of what is involved. The Informed Consent Form outlines the investigational medication's known safety information and provides background on what the study involves.
Once enrolled, you will visit your doctor who will run tests to confirm that you are eligible to participate. Your doctor and study team should be available to answer questions throughout the process.
What side effects should I expect?
The Informed Consent Form will provide details on all of the known safety information on the investigational medication. Please direct any additional questions to your doctor.
Do I have to pay to participate in a clinical study?
No. The investigational medication and associated diagnostics are provided free of charge to clinical study participants.
How do I get started?
Please sign up to provide your contact information and answer a few questions.