A study for breast cancer that has spread to other parts of the body.

Trial ID:
Mohammed Ali Jaloudi, MD
This is an open-label study comparing two different investigational combinations of anti-cancer medications for ER-positive/HER2-negative breast cancer that has spread to parts of the body beyond the breast.

Participants will be randomly assigned to one of the following groups:
Group 1: Giredestrant + Everolimus(AFINITOR)

Group 2: Exemestane(AROMASIN) + Everolimus(AFINITOR)

There is no placebo in this clinical study. Everyone receives treatment with a combination of oral breast cancer medications taken once per day for each 28Day cycle. Treatment is given in cycles of 28Days (4Weeks). For the first two cycles, study visits are required on Day 1 and Day 15 of each cycle. For Cycles 3 and beyond, study visits are required on Day 1 only. Study visits include health checks, tests, and questionnaires.

Treatment cycles will continue until your cancer no longer responds to the treatment, your body does not tolerate the treatment, or you change your mind.

Inclusion Criteria

Patients must:
  • Have estrogen receptor (ER)-positive/human epidermal growth factor (HER2)-negative cancer; AND
  • Have been previously treated for breast cancer; AND
  • Have cancer that has returned or worsened; AND
  • Have cancer that has spread in a way that cannot be treated with surgery.

Exclusion Criteria

Patients must not:
  • Have significant bowel disease, chronic diarrhea or major upper gastrointestinal surgery potentially affecting the absorption of oral medications;
  • Have significant lung disease requiring oxygen therapy;
  • Be pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of oral medication.

Additional Info

  • All study visits will be scheduled at Scripps Clinic Torrey Pines or Scripps Clinic Encinitas.
  • Search NCT05306340 at https://clinicaltrials.gov website for more information

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org