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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 540 משתתפים231 אתרים24 מדינות

קטגוריות

אונקולוגיה83%רפואת עור10%אנדוקריני ומטבולי6%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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.

מצבים רפואיים

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

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 540 משתתפים

נותן חסות ושותפים

  • Relay Therapeutics, Inc. נותן חסות

זרועות והתערבויות

  • 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

התערבויות

  • תרופה 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

  • תרופה Fulvestrant

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

  • תרופה Zovegalisib

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

מדדי תוצאה

  1. מדד תוצאה ראשוני

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

    מסגרת זמן 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. מדד תוצאה משני

    Overall Survival (OS) within the overall and kinase populations

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

  3. מדד תוצאה משני

    PFS by Investigator within the overall and kinase populations

    מסגרת זמן 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. מדד תוצאה משני

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

    מסגרת זמן Up to approximately 77 months

  5. מדד תוצאה משני

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

    מסגרת זמן Up to approximately 77 months

  6. מדד תוצאה משני

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

    מסגרת זמן Up to approximately 77 months

  7. מדד תוצאה משני

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

    מסגרת זמן Up to approximately 77 months

  8. מדד תוצאה משני

    Plasma concentrations of zovegalisib (and its metabolites as appropriate)

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

  9. מדד תוצאה משני

    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

    מסגרת זמן Up to approximately 77 months

  10. מדד תוצאה משני

    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

    מסגרת זמן Up to approximately 77 months

  11. מדד תוצאה משני

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

    מסגרת זמן Up to approximately 77 months

תאריכים

תאריך התחלה26 באוגוסט 2025 (בפועל)
סיום ראשוני30 באפריל 2028 (משוער)
סיום31 בדצמבר 2031 (משוער)
פורסם לראשונה21 במאי 2025 (בפועל)
עודכן לאחרונה3 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהיולי 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

231 אתרים מגייסים

Argentina

מתקןעירמדינה או אזורמצב
Organización Médica de Investigación (OMI)Buenos Airesמגייס
Centro Medico Dr. Doreski- Fundacion RespirarBuenos Airesמגייס
Hospital Britanico de Buenos AiresBuenos Airesמגייס
Instituto de Investigaciones Clinicas de CordobaCórdobaמגייס
Breast clinica de la mamaLa Plataמגייס
Hospital Provincial del CentenarioRosarioמגייס
Instituto de Oncología de RosarioRosarioמגייס
Centro de Investigaciones Clinicas. Clinica Viedma S.A.Viedmaמגייס

Australia

מתקןעירמדינה או אזורמצב
Monash HealthClaytonVictoriaמגייס
St. Vincent's Hospital SydneyDarlinghurstNew South Walesמגייס
Lake Macquarie HospitalGatesheadNew South Walesמגייס
Barwon HealthGeelongVictoriaמגייס
Bayside Health (Alfred)MelbourneVictoriaמגייס
Peter MacCallum Cancer CenterMelbourneVictoriaמגייס
Mater Hospital SydneyNorth SydneyNew South Walesמגייס
Sunshine HospitalSaint AlbansVictoriaמגייס
Sydney Adventist HospitalWahroongaNew South Walesמגייס
Ballarat Oncology & Haematology Clinical Research FundWendoureeVictoriaמגייס

Austria

מתקןעירמדינה או אזורמצב
Medical University of GrazGrazמגייס
Ordensklinikum Linz GmbHLinzמגייס
LKH Feldkirch, Interne E am LKH RankweilRankweilמגייס

Belgium

מתקןעירמדינה או אזורמצב
Universitair Ziekenhuis AntwerpenAntwerpמגייס
Cliniques Universitaires Saint-LucBrusselsמגייס
Institut Jules BordetBrusselsמגייס
Ghent University HospitalGhentמגייס
Universitair Ziekenhuis BrusselJetteמגייס
Universitair Ziekenhuis LeuvenLeuvenמגייס
Centre Hospitalier de l'ArdenneLibramontמגייס
Clinique CHC Mont LegiaLiègeמגייס
CHU-UCL Namur, Site Sainte-ElisabethNamurמגייס
VitazSint-Niklaasמגייס
CHR de Verviers site TourelleVerviersמגייס

Brazil

מתקןעירמדינה או אזורמצב
Oncolinicas do Brasil Serviços Médicos S.A (Oncocentro)Belo Horizonteמגייס
CEMEC CTO (CPAM - Centro de Pesquisas da Amazônia)Belémמגייס
Instituto do Câncer do CearáFortalezaמגייס
Hospital de Cancer Araujo Jorge/ Associacao de Combate ao Cancer em GoiasGoiâniaמגייס
Oncoclinicas Natal- Centro de Pesquisa Oncology NatalNatalמגייס
Associação Hospitalar Moinhos de VentoPorto Alegreמגייס
Uniao Brasileira de Educacao e Assistencia/ Hospital Sao Lucas da PUCRSPorto Alegreמגייס
Centro Gaúcho Integrado - Hospital Mae de DeusPorto Alegreמגייס
Hospital de Clinicas de Porto AlegrePorto Alegreמגייס
Irmandade da Santa Casa de Misericórdia de Porto AlegrePorto Alegreמגייס
Oncoclinicas Rio de Janeiro S.A.Rio de Janeiroמגייס
Instituto de Educação Pesquisa e Gestão em SaúdeRio de Janeiroמגייס
Nucleo de Oncologia da Bahia S.A.Salvadorמגייס
Centro de Oncologia do ABC- CEON+ Unidade Sao Caetano do SulSão Caetano do Sulמגייס
Sociedade Beneficente de Senhora Hospital Sírio-LibanêsSão Pauloמגייס
Clinica Onco StarSão Pauloמגייס

Bulgaria

מתקןעירמדינה או אזורמצב
MHAT "Dr. Tota Venkova", ADGabrovoמגייס
Acibadem City Clinic Tokuda University Hospital EADSofiaמגייס

181 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 3 בספטמבר 2026

    אתר נוסף

    9 sites added (231 total)

    222231

  2. 5 באוגוסט 2026

    אתר נוסף

    11 sites added (222 total)

    211222

מרשם: ClinicalTrials.gov · NCT########

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