Treatments & (Clinical) Trials

There is no cure; there are multiple treatments for Metastatic Breast Cancer (MBC). The “standard of care” is treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called best practice, standard medical care, and standard therapy. (National Cancer Institute)

Other people with MBC may be on different medications and treatment due to their subtype of breast cancer and/or their ability to tolerate medication.

A treatment only becomes approved by the U.S. Food and Drug Administration (FDA) after extensive testing. There are generally 4 phases of testing or clinical trials.

  • Phase I trials test the safety of the drug, side effects and dosage with a small number of people.
  • Phase II trials involves a larger group and focuses on safety and effectiveness of the treatment.
  • In Phase III clinical trials, a larger group of people test effectiveness, monitor side effects, compare it to commonly used treatments, & collect information that will allow it to be used safely.
  • Phase IV clinical trials are conducted after FDA approval for final safety and risk assessment.

Clinical trials are critically important because it’s the only way new treatments and medications make it into the standard of care. It’s important for patients to participate in clinical trials, if they are comfortable.

I summarize here my treatments and the clinical trials I’ve participate in (or tried to).

July 2019 Treatment (first line)
Ibrance (CDK 4/6 inhibitor) – oral medication, once daily
Anastrazole (Aromatease inhibitor) – oral medication, once daily
Lupron (shuts down ovaries) – monthly shot
Zometa (bone strengthener) – infusion (monthly, then quarterly)
August 2021Phase II clinical trial: ELAINE II – did not qualify – did not have ESR1 mutation required for participation
April 2022Phase III clinical trial: SERENA-6 – enrolled in phase 1, monitoring. Had progression and had to leave the trial.
June 2022Change of Treatment (second line)

Phase III clinical trial: postMONARCH
Flaslodex (Fulvestrant) +
either Verzenio (CDK 4/6) or Placebo

Lupron (shuts down ovaries) – monthly shot
Zometa (bone strengthener) – infusion (monthly, then quarterly)