A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)

The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.

Trial Details

NCT ID
NCT07541079
Phase
PHASE3
Sponsor
Genentech, Inc.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Giredestrant
Locations (sample)
  • Fountain Valley, California, United States|33.70918,-117.95367
  • Stockton, California, United States|37.9577,-121.29078
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Sterling Heights, Michigan, United States|42.58031,-83.0302
  • Reno, Nevada, United States|39.52963,-119.8138

Key Eligibility Criteria

  • Considered appropriate for treatment with endocrine therapy (ET)
  • Histologically confirmed diagnosis of ER+/HER2-, Stage I-III (low-/medium-/high-risk) early breast cancer (eBC)
  • Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP), defined as ≥1% of tumor cell…
  • Documented HER2- tumor according to ASCO/CAP

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find HER2 Positive Breast Cancer Trials on Trialify →