A Phase 3 interventional study of Giredestrant in Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer and HER2-Negative Breast Cancer, sponsored by Hoffmann-La Roche. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC) who are treated with giredestrant.
The study will have two cohorts. Cohort A will comprise a broad upfront patient population with low-, medium-, or high-risk eBC. Cohort B will comprise patients with medium- or high-risk eBC who have completed adjuvant treatment with cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) (abemaciclib or ribociclib) and endocrine therapy and who are now switching to giredestrant monotherapy.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive giredestrant.
Drug: Giredestrant
Participants will receive giredestrant.
Drug: Giredestrant
Participants will receive giredestrant 30 mg orally once a day for up to 5 years.
Also known as: RO7197597, GDC-9545, RG6171
Incidence of Participants who Have Discontinued Giredestrant for any Reason
Time frame: Month 12
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to approximately 5 years
Treatment Adherence, as Measured by Dose Intensity
Time frame: Up to approximately 5 years
Treatment Adherence, as Measured by Treatment Duration
Time frame: Up to approximately 5 years
Cohort A: Mean Absolute Score for Joint Pain as Assessed by Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Joint Pain Score as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Hot Flashes as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Hot Flashes Score as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Vaginal Dryness as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Vaginal Dryness Score as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Sexual Dysfunction as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Sexual Dysfunction Score as Assessed by FACT-ES
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for the Overall Endocrine Symptom Burden as Assessed by FACT-ES Endocrine Symptom Subscale Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in the Overall Endocrine Symptom Burden Score as Assessed by FACT-ES Endocrine Symptom Subscale Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Pain as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Pain Severity Composite Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Pain as Assessed by the BPI-SF Pain Severity Composite Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Pain Interference as Assessed by the BPI-SF Pain Interference Composite Score
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Percentage of Participants Reporting Each Response Option for the Treatment Side-Effect Bother Single-Item GP5 (General Physical Well-Being Item 5) as Assessed by the Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Change From Baseline in the Treatment Side-Effect Bother Single-Item GP5 as Assessed by FACT-G
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort B: Percentage of Participants Achieving Improvement in Joint Pain Score as Assessed by FACT-ES
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Hot Flashes Score as Assessed by FACT-ES
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Vaginal Dryness Score as Assessed by FACT-ES
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Sexual Dysfunction Score as Assessed by FACT-ES
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Endocrine Therapy-Specific Symptom Burden as Assessed by the FACT-ES Endocrine Symptom Subscale Score
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Severity Composite Score
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-Related Burden as Assessed by the BPI-SF Pain Interference Composite Score
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Achieving Improvement in Global Treatment Bother as Assessed by the Single-Item GP5 From the FACT-G
Time frame: Month 6 and Month 12
Cohort A: Mean Absolute Score for Physical Function as Assessed by the European Organization for Research and Treatment of Cancer Item Library 492 (EORTC IL 492)
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Physical Function Score as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Role Function as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Role Function Score as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Cognitive Function as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in Cognitive Function Score as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Absolute Score for Health-Related Quality of Life (HRQoL) as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort A: Mean Change From Baseline in HRQoL Score as Assessed by EORTC IL 492
Time frame: At prespecified timepoints from Baseline until approximately 5 years
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Physical Function as Assessed by EORTC IL 492
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Role Function as Assessed by EORTC IL 492
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in Cognitive Function as Assessed by EORTC IL 492 Subscale Score
Time frame: Month 6 and Month 12
Cohort B: Percentage of Participants Categorized as Improved, Stable, or Worsened in HRQoL as Assessed by EORTC IL 492 Subscale Score
Time frame: Month 6 and Month 12
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Giredestrant