Clinical trials of Metastatic Breast Cancer

Executive Summary

Clinical trials are considered a better method for treating metastatic breast cancer. The evaluation of new drugs, different combinations of treatments, new approaches to radiation therapy or surgery, and new therapies are integrated into metastatic breast cancer clinical trials. New treatments with better efficacy and safety are the outcome of a clinical trial. The results of the clinical trials have been effective in reducing the symptoms and side effects during the treatment.

In all forms and stages of breast cancer, clinical trials of metastatic breast cancer are can help for its medication. Volunteers or patients willing to participate in the clinical trials should communicate with their doctor and healthcare team and research expertise to make well decided informed choices regarding participating in the problem while signing informed consent. Hence, the volunteers willingly participate as they know the studies are a way to help advance the treatment of early- and late-stage metastatic breast cancer.

Clinical Trial of Metastatic Breast Cancer

All around the globe, researchers and advanced technologists constantly explore new and efficient ways to treat breast cancer patients. Additionally, researchers and advanced technologists go ahead with clinical trials involving volunteers in research studies to drive scientific development. Clinical trials examines every drug that has now been approved by the US F&D (Food and Drug) Administration ​1​.

Plenty of them go for a new medication to understand if it is safe, sound, effective, and possibly better than the rest of the current medications. The ones who participate in clinical trials are some of the very first to get it before it could reach ordinary people. These trials examine new drugs in the market, the different medication varieties, and new radiation therapy or surgery. When there’s something new, it does hold some risks and side effects, and sometimes it could all go in vain. So the patients and their families are first backed and encouraged to have a conversation with their GP before making any significant decisions ​2​.

People opt for clinical trials for a variety of reasons

For several groups of people, a clinical trial is one of the most genuine options for medication. As primary therapies aren’t perfect and so, the people are usually willing to head on fight the extra uncertainty of a clinical study to get better results. Others participate in clinical trials because they understand that they are helping advance the treatment of metastatic breast cancer ​3​. Even if individuals /patients do not benefit directly from the clinical research, their participation may assist future patients with metastatic breast cancer.

Cancer costs and insurance coverage 

It varies depending on region and topic. Some organizations compensate some of the expenses associated with participating in a clinical trial. They aren’t in some cases. Approach the research team and your insurance provider first to know if they will reimburse the clinical trial cost. And so, find out if your health insurance covers clinical trials.

Patient safety and informed consent

People must accept to participate in a clinical trial through informed consent. The GP should conduct the following during informed consent.

  • Explain all medical options so that the patient understands how the new medication differs from the old one.
  • List out all the risks involved with the new medication, which may or may not differ from the risks involved with routine care.
  • Make each person understand what is expected to achieve to take part in the clinical study, such as the number of visits, tests, and medication structure.

Eligibility Criteria

Clinical trials also contain eligibility criteria, which assist in structuring the research and keeping patients safe. The research team basically will go over these criteria thoroughly together.

Participants in clinical trials of metastatic breast cancer have the right to reject at any moment for personal or medical reasons ​4​. It could also indicate that the new medicine is ineffective or has significant side effects. Clinical trials are also thoroughly regulated by experts who watch each study for any problems. People enrolled in a clinical trial should discuss with their GP and researchers who will be giving their treatment and care during the examination after the trial is done.


  1. 1.
    Schreiber AR, Kagihara JA, Weiss JA, et al. Clinical Outcomes for Patients With Metastatic Breast Cancer Treated With Immunotherapy Agents in Phase I Clinical Trials. Front Oncol. Published online March 17, 2021. doi:10.3389/fonc.2021.640690
  2. 2.
    Levine M. Clinical trial design in metastatic breast cancer: a commentary. Can J Oncol. 1995;5 Suppl 1:40-42.
  3. 3.
    Seidman AD, Maues J, Tomlin T, Bhatnagar V, Beaver JA. The Evolution of Clinical Trials in Metastatic Breast Cancer: Design Features and Endpoints That Matter. American Society of Clinical Oncology Educational Book. Published online May 2020:44-54. doi:10.1200/edbk_280451
  4. 4.
    Conde-Estévez D, Tusquets I, Servitja S, Martínez-García M, Salas E, Albanell J. An overview of randomized clinical trials in metastatic breast cancer. Anti-Cancer Drugs. Published online October 2014:992-997. doi:10.1097/cad.0000000000000130