Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Giredestrant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Giredestrant | Drug | Participants will receive giredestrant at a dose of 30 mg orally once daily on Days 1-28 of each 28-day cycle for up to 4.5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months | At 12 months | |
| Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0) | From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving an Improvement in Individual Endocrine Therapy-specific Symptoms at 6 and 12 Months, Using the FACT-ES Questionnaire | An improvement in individual endocrine therapy-specific symptoms (joint pain, hot flashes, vaginal dryness, and sexual dysfunction) is defined as ≥1-point/shift increase from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire items. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GO46747 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, 6 and 12 months |
| Percentage of Participants Categorized as Improved, Stable, or Worsening in Endocrine Therapy-specific Symptom Burden at 6 and 12 Months, Using the FACT-ES Questionnaire | Categories are defined by a change from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire Additional Concerns subscale score using a minimal important difference (MID) threshold of ±3 points. | Baseline, 6 and 12 months |
| Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-related Burden at 6 and 12 Months, Using the BPI-SF Questionnaire | Categories are defined by a change from baseline in the Brief Pain Inventory-Short Form (BPI-SF) Pain Severity composite score (minimal important difference [MID] of ±2 points) and the BPI-SF Pain Interference composite score (MID of ±1 point). | Baseline, 6 and 12 months |
| Percentage of Participants Achieving an Improvement in Global Treatment Bother at 6 and 12 Months, Using the FACT-ES Questionnaire's GP5 Item | An improvement is defined as a ≥1-point increase from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) GP5 item ('I am bothered by side-effects of treatment'). | Baseline, 6 and 12 months |
| Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Physical Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire | Categories are defined by a change from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Physical Well-Being subscale scores using a minimal important difference (MID) threshold of ±2 points. | Baseline, 6 and 12 months |
| Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Functional Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire | Categories are defined by a change from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Functional Well-Being subscale scores using a minimal important difference (MID) threshold of ±2 points. | Baseline, 6 and 12 months |
| Percentage of Participants Categorized as Improved, Stable, or Worsened in Global Health-Related Quality of Life (HRQoL) at 6 and 12 Months, Using the FACT-ES Questionnaire | Categories are defined by a change from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Total Score using a minimal important difference (MID) threshold of ±7 points. | Baseline, 6 and 12 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000720132 | giredestrant |
Not provided
Not provided
Not provided