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Compares treatment options for PIK3CA Mutation
Official title Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
ClinicalTrials.gov ID: NCT06982521
What this study is testing
What is RLY-2608?
RLY-2608 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pik3ca mutation.
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
- This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
You may be able to join if
- Patient has ECOG performance status of 0-1
- One or more known primary oncogenic PIK3CA mutation(s)
- Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with...
- Histologically or cytologically confirmed diagnosis of HR+/HER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective...
- Measurable disease per RECIST v1.1 or evaluable bone-only disease.
You likely can't join if
- Prior treatment with any of the following:
- CDK2 or selective CDK4 inhibitors or any investigational therapies targeting cyclin dependent kinases
- PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3/AKT/mTOR pathway
- Immunotherapy
- Antibody drug conjugates
- Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg/dL, or glycosylated hemoglobin (HbA1c)...
See the full eligibility criteria
- Patient has ECOG performance status of 0-1
- One or more known primary oncogenic PIK3CA mutation(s)
- Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing hormone (GnRH) agonist. Patients are to have...
- Histologically or cytologically confirmed diagnosis of HR+/HER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective evidence of recurrence or progression; locally advanced disease must not...
- Measurable disease per RECIST v1.1 or evaluable bone-only disease.
- Must have radiological evidence of progression on or after previous treatment for HR+/HER2- ABC with:
- At least 1 and no more than 2 lines of endocrine therapy (ET) in the (neo)adjuvant setting with recurrence on or within 12 months of completion or in the ABC setting
- 1 prior line of CDK4/6 inhibitor therapy in one of the following settings:
- CDK4/6 inhibitor + ET in the ABC setting
- CDK4/6 inhibitor therapy in the adjuvant setting if progression occurred during or within 12 months of completion of adjuvant CDK4/6 inhibitor with ET
- Patients who progressed during or within 12 months of completion of adjuvant CDK4/6 inhibitor and after receiving CDK4/6 inhibitor therapy in the advanced setting are considered to have had \>1 prior line of CDK4/6...
- Prior treatment with any of the following:
- CDK2 or selective CDK4 inhibitors or any investigational therapies targeting cyclin dependent kinases
- PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3/AKT/mTOR pathway
- Immunotherapy
- Antibody drug conjugates
- Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg/dL, or glycosylated hemoglobin (HbA1c) ≥7.0% (≥ 53 mmol/mol).
- Clinically significant, uncontrolled cardiovascular disease
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
- Known active uncontrolled or symptomatic CNS metastases associated with progressive neurological symptoms or requiring ongoing corticosteroids or anticonvulsants for symptomatic control
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- History of hypersensitivity to fulvestrant or drugs in a similar class as fulvestrant, RLY-2608, or capivasertib, including their excipients
- Known activating AKT mutations, loss-of-function PTEN mutations, or loss of PTEN expression resulting in oncogenic pathway activation downstream of PI3K
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Beverly Hills, California, United States
- Duarte, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Vallejo, California, United States
- Longmont, Colorado, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Washington D.C., District of Columbia, United States
- Altamonte Springs, Florida, United States
- Fort Myers, Florida, United States
- Palm Bay, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Westwood, Kansas, United States
+ 151 more site(s).
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 - 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Beverly Hills, California, United States; Duarte, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Sacramento, California, United States and 165 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.