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)

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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 cells stained positive

Documented HER2- tumor according to ASCO/CAP

Disqualifiers

Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents

Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease

Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)

Have active cardiac disease or history of cardiac dysfunction

Trial design

Treatments tested in this trial

  • Giredestrant

Treatment groups

300 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators