Early Breast Cancer study: Giredestrant
Official title 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)
ClinicalTrials.gov ID: NCT07541079
What this study is testing
What is Giredestrant?
Giredestrant is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for early breast cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how well patients stick to giredestrant and how they feel about side effects and quality of life after switching from an aromatase inhibitor.
- Who it's for
- Adults with stage I‑III estrogen‑receptor‑positive, HER2‑negative early breast cancer who are unable to tolerate a prior aromatase inhibitor.
- What's involved
- Participants will take giredestrant as their ongoing hormone (endocrine) treatment and will attend clinic visits and fill out questionnaires about symptoms and daily life.
- Time commitment
- They will be followed for the full course of the giredestrant treatment, with regular study visits and assessments throughout.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Documented HER2- tumor according to ASCO/CAP
- Postmenopausal females at the time of signing the Informed Consent Form
You likely can't join if
- Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer...
- 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...
- Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study...
See the full 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 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
- 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...
- Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Huntsville, Alabama, United States
- Clovis, California, United States
- Fountain Valley, California, United States
- Stockton, California, United States
- Norwich, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Sterling Heights, Michigan, United States
- Reno, Nevada, United States
- East Brunswick, New Jersey, United States
- New Brunswick, New Jersey, United States
- Albuquerque, New Mexico, United States
- Albany, New York, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Huntsville, Alabama, United States; Clovis, California, United States; Fountain Valley, California, United States; Stockton, California, United States; Norwich, Connecticut, United States; Washington D.C., District of Columbia, United States and 7 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.