Early Breast CancerPhase 3NCT07541079
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)
A Phase 3 study testing Giredestrant in people with Early Breast Cancer, run by Genentech, Inc. at 8 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Breast Cancer
- What is being tested?
- Giredestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 8 sitesUnited States
- Study dates
- 25 Aug 2026to 30 Jun 2034
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Postmenopausal females at the time of signing the Informed Consent Form
- Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months
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- Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent
- Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment
- Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance
- Participant and investigator planning the first switch from an AI
- Has completed the following: (neo)adjuvant chemotherapy (if administered), definitive surgery of primary breast tumor(s) and/or axillary lymph nodes dissection (ALND) and/or sentinel lymph node biopsy (SLNB) and/or radiotherapy
- Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1
Who cannot join
- 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
- Have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
- Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
- Have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GO46747 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
New York Oncology Hematology (Patroon) - USOR
Albany, New York, 12206-5013
- Recruiting
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816-4096
- Recruiting
Orange Coast Medical Center
Fountain Valley, California, 92708-6728
- Recruiting
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
- Recruiting
Renown Health Conrad Breast Center at South Meadows
Reno, Nevada, 89521
- Recruiting
Cancer and Leukemia Center
Sterling Heights, Michigan, 48314
- Recruiting
Stockton Hematology Oncology Medical Group-2626 N California St
Stockton, California, 95204-6019
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010-3017
About this study
Official title: A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy
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.
- Conditions
- Early Breast Cancer
- Being tested
- Giredestrant
- Keywords
- Estrogen receptor positive, ER+, Human epidermal growth factor receptor 2 negative, HER2-
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GiredestrantDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Giredestrant | Experimental | Not described Receives: Drug: Giredestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months
Measured: 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)
Measured: From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: 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').
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start25 Aug 2026
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541079
- Sponsor's protocol ID
- GO46747
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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