Informations générales (source: ClinicalTrials.gov)
A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor
Interventional
Phase 3
Relay Therapeutics, Inc. (Voir sur ClinicalTrials)
août 2025
décembre 2031
28 mai 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Cyril ROUSSEL SIMONIN | 12/06/2026 14:20:05 | Contacter | ||
Critères
Tous
- 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 commenced
treatment with a GnRH agonist at least 4 weeks prior to randomization and must be
willing to continue on it for the duration of the study.
- 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 be amenable to resection with
curative intent
- 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:
1. 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
2. 1 prior line of CDK4/6 inhibitor therapy in one of the following settings:
1. CDK4/6 inhibitor + ET in the ABC setting
2. 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
3. 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
inhibitor and are not eligible
Exclusion Criteria:
- Prior treatment with any of the following:
1. CDK2 or selective CDK4 inhibitors or any investigational therapies targeting
cyclin dependent kinases
2. PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the
inhibit the PIK3/AKT/mTOR pathway
3. Immunotherapy
4. 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