NCT06982521ClinicalTrials.gov

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

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

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on…

Phase 3540 participants recherchés231 sites24 pays

Catégories

Oncologie83%Dermatologie10%Endocrinien et métabolique6%

Enregistré dans 1 registre

ClinicalTrials.govNCT06982521Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 semaines

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-05-21; recorded start 2025-08-26
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 7 other studies in this databaseCounted from the lead sponsor named in the record (Relay Therapeutics, Inc.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 6 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding0/20
Open-label
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 211 sites
Data monitoring committee0/7
Data monitoring committee not stated in the record
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 540 participants (target), run at 231 sites, across 24 countries.

How this score is built

Enrolment27/40
540 participants (target)
Site count25/25
211 sites
Country count15/15
23 countries
Planned duration10/10
Planned over about 77 months
Sponsor scale3/10
Relay Therapeutics, Inc. has led 8 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

Affections

PIK3CA Mutation
HER2- Negative Breast Cancer
Hormone Receptor Positive Tumor
Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

Inclusion 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 commenced treatment with a GnRH agonist at least 2 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. Only 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 inhibitors. Prior treatment with other investigational CDK inhibitors could be permitted upon discussion and approval from the Sponsor 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 (7.8 mmol/L), 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, zovegalisib, 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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	NONE (0)
Recrutement	540 participants recherchés

Promoteur et collaborateurs

Relay Therapeutics, Inc. Promoteur

Groupes et interventions

Zovegalisib + fulvestrantEXPERIMENTAL
Zovegalisib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer
capivasertib + fulvestrantACTIVE_COMPARATOR
capivasertib + fulvestrant combination for participants with HR+/HER2- advanced breast cancer

Interventions

Médicament Capivasertib
400mg orally BID administered on an intermittent weekly dosing schedule. Patients will dose on Days 1 through 4 each week of a 28-day treatment cycle
Médicament Fulvestrant
500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle)
Médicament Zovegalisib
400 mg orally BID administered daily on a 28-day treatment cycle

Critères de jugement

Critère de jugement principal
Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)
Délai The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months
Critère de jugement secondaire
Overall Survival (OS) within the overall and kinase populations
Délai The time from randomization to the date of death by any cause, up to approximately 77 months
Critère de jugement secondaire
PFS by Investigator within the overall and kinase populations
Délai The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months
Critère de jugement secondaire
Objective Response Rate (ORR) within the overall and kinase populations
Délai Up to approximately 77 months
Critère de jugement secondaire
Duration of Response (DOR) within the overall and kinase populations
Délai Up to approximately 77 months
Critère de jugement secondaire
Clinical Benefit Rate (CBR) within the overall and kinase populations
Délai Up to approximately 77 months
Critère de jugement secondaire
Occurrence/frequency of Adverse Events (AEs) and its relationship to the study drugs (safety and tolerability) within the overall and kinase populations
Délai Up to approximately 77 months
Critère de jugement secondaire
Plasma concentrations of zovegalisib (and its metabolites as appropriate)
Délai Approximately every 2 weeks in Cycle 1 (4-week cycle) and during Cycles 2 and 3
Critère de jugement secondaire
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) scale/item scores including change from baseline and time to deterioration within overall and kinase populations
Délai Up to approximately 77 months
Critère de jugement secondaire
EORTC Quality of Life Questionnaire Breast Cancer-Specific Module (EORTC QLQ-BR23) scale/item scores including change from baseline and time to deterioration within the overall and kinase populations
Délai Up to approximately 77 months
Critère de jugement secondaire
Health state utility data for economic evaluation by EQ-5D-5L health state utility index within the overall and kinase populations
Délai Up to approximately 77 months

Dates

Dates
Date de début	26 août 2025 (réelle)
Achèvement principal	30 avril 2028 (estimée)
Achèvement	31 décembre 2031 (estimée)
Première publication	21 mai 2025 (réelle)
Dernière mise à jour	3 septembre 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	juillet 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

231 sites sont en recrutement

Argentina

Argentina
Établissement	Ville	Statut
Organización Médica de Investigación (OMI)	Buenos Aires	En recrutement
Centro Medico Dr. Doreski- Fundacion Respirar	Buenos Aires	En recrutement
Hospital Britanico de Buenos Aires	Buenos Aires	En recrutement
Instituto de Investigaciones Clinicas de Cordoba	Córdoba	En recrutement
Breast clinica de la mama	La Plata	En recrutement
Hospital Provincial del Centenario	Rosario	En recrutement
Instituto de Oncología de Rosario	Rosario	En recrutement
Centro de Investigaciones Clinicas. Clinica Viedma S.A.	Viedma	En recrutement

Australia

Australia
Établissement	Ville	État ou région	Statut
Monash Health	Clayton	Victoria	En recrutement
St. Vincent's Hospital Sydney	Darlinghurst	New South Wales	En recrutement
Lake Macquarie Hospital	Gateshead	New South Wales	En recrutement
Barwon Health	Geelong	Victoria	En recrutement
Bayside Health (Alfred)	Melbourne	Victoria	En recrutement
Peter MacCallum Cancer Center	Melbourne	Victoria	En recrutement
Mater Hospital Sydney	North Sydney	New South Wales	En recrutement
Sunshine Hospital	Saint Albans	Victoria	En recrutement
Sydney Adventist Hospital	Wahroonga	New South Wales	En recrutement
Ballarat Oncology & Haematology Clinical Research Fund	Wendouree	Victoria	En recrutement

Austria

Austria
Établissement	Ville	Statut
Medical University of Graz	Graz	En recrutement
Ordensklinikum Linz GmbH	Linz	En recrutement
LKH Feldkirch, Interne E am LKH Rankweil	Rankweil	En recrutement

Belgium

Belgium
Établissement	Ville	Statut
Universitair Ziekenhuis Antwerpen	Antwerp	En recrutement
Cliniques Universitaires Saint-Luc	Brussels	En recrutement
Institut Jules Bordet	Brussels	En recrutement
Ghent University Hospital	Ghent	En recrutement
Universitair Ziekenhuis Brussel	Jette	En recrutement
Universitair Ziekenhuis Leuven	Leuven	En recrutement
Centre Hospitalier de l'Ardenne	Libramont	En recrutement
Clinique CHC Mont Legia	Liège	En recrutement
CHU-UCL Namur, Site Sainte-Elisabeth	Namur	En recrutement
Vitaz	Sint-Niklaas	En recrutement
CHR de Verviers site Tourelle	Verviers	En recrutement

Brazil

Brazil
Établissement	Ville	Statut
Oncolinicas do Brasil Serviços Médicos S.A (Oncocentro)	Belo Horizonte	En recrutement
CEMEC CTO (CPAM - Centro de Pesquisas da Amazônia)	Belém	En recrutement
Instituto do Câncer do Ceará	Fortaleza	En recrutement
Hospital de Cancer Araujo Jorge/ Associacao de Combate ao Cancer em Goias	Goiânia	En recrutement
Oncoclinicas Natal- Centro de Pesquisa Oncology Natal	Natal	En recrutement
Associação Hospitalar Moinhos de Vento	Porto Alegre	En recrutement
Uniao Brasileira de Educacao e Assistencia/ Hospital Sao Lucas da PUCRS	Porto Alegre	En recrutement
Centro Gaúcho Integrado - Hospital Mae de Deus	Porto Alegre	En recrutement
Hospital de Clinicas de Porto Alegre	Porto Alegre	En recrutement
Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	En recrutement
Oncoclinicas Rio de Janeiro S.A.	Rio de Janeiro	En recrutement
Instituto de Educação Pesquisa e Gestão em Saúde	Rio de Janeiro	En recrutement
Nucleo de Oncologia da Bahia S.A.	Salvador	En recrutement
Centro de Oncologia do ABC- CEON+ Unidade Sao Caetano do Sul	São Caetano do Sul	En recrutement
Sociedade Beneficente de Senhora Hospital Sírio-Libanês	São Paulo	En recrutement
Clinica Onco Star	São Paulo	En recrutement

Bulgaria

Bulgaria
Établissement	Ville	État ou région	Statut
MHAT "Dr. Tota Venkova", AD	Gabrovo		En recrutement
Acibadem City Clinic Tokuda University Hospital EAD	Sofia		En recrutement

181 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

3 septembre 2026
Site ajouté
9 sites added (231 total)
222231
5 août 2026
Site ajouté
11 sites added (222 total)
211222

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06982521