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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 540 مشاركاً231 موقعاً24 دولة

الفئات

علم الأورام83%الأمراض الجلدية10%الغدد الصمّاء والأيض6%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

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

ملخص

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 or after treatment with a CDK4/6 inhibitor.

الحالات

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

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةNONE (0)
التجنيدمطلوب 540 مشاركاً

الجهة الراعية والمتعاونون

  • Relay Therapeutics, Inc. الجهة الراعية

الأذرع والتدخلات

  • 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

التدخلات

  • دواء 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

  • دواء Fulvestrant

    500 mg intramuscularly administered on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (28-day treatment cycle)

  • دواء Zovegalisib

    400 mg orally BID administered daily on a 28-day treatment cycle

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Progression-Free Survival (PFS) within the overall and kinase population by blinded independent central review (BICR)

    الإطار الزمني The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months

  2. مقياس النتيجة الثانوي

    Overall Survival (OS) within the overall and kinase populations

    الإطار الزمني The time from randomization to the date of death by any cause, up to approximately 77 months

  3. مقياس النتيجة الثانوي

    PFS by Investigator within the overall and kinase populations

    الإطار الزمني The time from date of randomization until radiographic progression per RECIST v1.1, or death due to any cause, up to approximately 77 months

  4. مقياس النتيجة الثانوي

    Objective Response Rate (ORR) within the overall and kinase populations

    الإطار الزمني Up to approximately 77 months

  5. مقياس النتيجة الثانوي

    Duration of Response (DOR) within the overall and kinase populations

    الإطار الزمني Up to approximately 77 months

  6. مقياس النتيجة الثانوي

    Clinical Benefit Rate (CBR) within the overall and kinase populations

    الإطار الزمني Up to approximately 77 months

  7. مقياس النتيجة الثانوي

    Occurrence/frequency of Adverse Events (AEs) and its relationship to the study drugs (safety and tolerability) within the overall and kinase populations

    الإطار الزمني Up to approximately 77 months

  8. مقياس النتيجة الثانوي

    Plasma concentrations of zovegalisib (and its metabolites as appropriate)

    الإطار الزمني Approximately every 2 weeks in Cycle 1 (4-week cycle) and during Cycles 2 and 3

  9. مقياس النتيجة الثانوي

    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

    الإطار الزمني Up to approximately 77 months

  10. مقياس النتيجة الثانوي

    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

    الإطار الزمني Up to approximately 77 months

  11. مقياس النتيجة الثانوي

    Health state utility data for economic evaluation by EQ-5D-5L health state utility index within the overall and kinase populations

    الإطار الزمني Up to approximately 77 months

التواريخ

تاريخ البدء26 أغسطس 2025 (فعلي)
الإتمام الأولي30 أبريل 2028 (تقديري)
الإتمام31 ديسمبر 2031 (تقديري)
أول نشر21 مايو 2025 (فعلي)
آخر تحديث3 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيوليو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

231 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Organización Médica de Investigación (OMI)Buenos Airesقيد التجنيد
Centro Medico Dr. Doreski- Fundacion RespirarBuenos Airesقيد التجنيد
Hospital Britanico de Buenos AiresBuenos Airesقيد التجنيد
Instituto de Investigaciones Clinicas de CordobaCórdobaقيد التجنيد
Breast clinica de la mamaLa Plataقيد التجنيد
Hospital Provincial del CentenarioRosarioقيد التجنيد
Instituto de Oncología de RosarioRosarioقيد التجنيد
Centro de Investigaciones Clinicas. Clinica Viedma S.A.Viedmaقيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Monash HealthClaytonVictoriaقيد التجنيد
St. Vincent's Hospital SydneyDarlinghurstNew South Walesقيد التجنيد
Lake Macquarie HospitalGatesheadNew South Walesقيد التجنيد
Barwon HealthGeelongVictoriaقيد التجنيد
Bayside Health (Alfred)MelbourneVictoriaقيد التجنيد
Peter MacCallum Cancer CenterMelbourneVictoriaقيد التجنيد
Mater Hospital SydneyNorth SydneyNew South Walesقيد التجنيد
Sunshine HospitalSaint AlbansVictoriaقيد التجنيد
Sydney Adventist HospitalWahroongaNew South Walesقيد التجنيد
Ballarat Oncology & Haematology Clinical Research FundWendoureeVictoriaقيد التجنيد

Austria

المنشأةالمدينةالولاية أو المنطقةالحالة
Medical University of GrazGrazقيد التجنيد
Ordensklinikum Linz GmbHLinzقيد التجنيد
LKH Feldkirch, Interne E am LKH RankweilRankweilقيد التجنيد

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
Universitair Ziekenhuis AntwerpenAntwerpقيد التجنيد
Cliniques Universitaires Saint-LucBrusselsقيد التجنيد
Institut Jules BordetBrusselsقيد التجنيد
Ghent University HospitalGhentقيد التجنيد
Universitair Ziekenhuis BrusselJetteقيد التجنيد
Universitair Ziekenhuis LeuvenLeuvenقيد التجنيد
Centre Hospitalier de l'ArdenneLibramontقيد التجنيد
Clinique CHC Mont LegiaLiègeقيد التجنيد
CHU-UCL Namur, Site Sainte-ElisabethNamurقيد التجنيد
VitazSint-Niklaasقيد التجنيد
CHR de Verviers site TourelleVerviersقيد التجنيد

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Oncolinicas do Brasil Serviços Médicos S.A (Oncocentro)Belo Horizonteقيد التجنيد
CEMEC CTO (CPAM - Centro de Pesquisas da Amazônia)Belémقيد التجنيد
Instituto do Câncer do CearáFortalezaقيد التجنيد
Hospital de Cancer Araujo Jorge/ Associacao de Combate ao Cancer em GoiasGoiâniaقيد التجنيد
Oncoclinicas Natal- Centro de Pesquisa Oncology NatalNatalقيد التجنيد
Associação Hospitalar Moinhos de VentoPorto Alegreقيد التجنيد
Uniao Brasileira de Educacao e Assistencia/ Hospital Sao Lucas da PUCRSPorto Alegreقيد التجنيد
Centro Gaúcho Integrado - Hospital Mae de DeusPorto Alegreقيد التجنيد
Hospital de Clinicas de Porto AlegrePorto Alegreقيد التجنيد
Irmandade da Santa Casa de Misericórdia de Porto AlegrePorto Alegreقيد التجنيد
Oncoclinicas Rio de Janeiro S.A.Rio de Janeiroقيد التجنيد
Instituto de Educação Pesquisa e Gestão em SaúdeRio de Janeiroقيد التجنيد
Nucleo de Oncologia da Bahia S.A.Salvadorقيد التجنيد
Centro de Oncologia do ABC- CEON+ Unidade Sao Caetano do SulSão Caetano do Sulقيد التجنيد
Sociedade Beneficente de Senhora Hospital Sírio-LibanêsSão Pauloقيد التجنيد
Clinica Onco StarSão Pauloقيد التجنيد

Bulgaria

المنشأةالمدينةالولاية أو المنطقةالحالة
MHAT "Dr. Tota Venkova", ADGabrovoقيد التجنيد
Acibadem City Clinic Tokuda University Hospital EADSofiaقيد التجنيد

يُدرَج 181 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 3 سبتمبر 2026

    أُضيف موقع

    9 sites added (231 total)

    222231

  2. 5 أغسطس 2026

    أُضيف موقع

    11 sites added (222 total)

    211222

السجل: ClinicalTrials.gov · NCT########

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