A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

  • Cancer
  • Breast Cancer
  • Early Breast Cancer
  • Breast Cancer Er-Positive
  • Breast Cancer HER-2 Negative
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Cities
  • _
  • A Coruña
  • Aarau
  • ABD
  • Adana
  • Adelaide
  • Aguascalientes
  • Ahmedabad
  • Albacete
  • Alcorcón
  • Alexandria Governorate
  • alicante--alacant-
  • Alvarado
  • Amiens
  • Ankara
  • Ann Arbor
  • Antalya
  • Antwerpen
  • Argenteuil
  • Asheville
  • Athens
  • Auchenflower
  • Augsburg
  • Avellino
  • bacolod
  • Badalona
  • Baden
  • Baguio
  • Bahia
  • Bakersfield
  • Banja Luka
  • Bankstown
  • Barcelona
  • Basel
  • Baton Rouge
  • Batumi
  • Be'er Sheva
  • Bedford Park
  • bei-jing-shi
  • belagavi
  • Bellavista
  • Bendigo
  • Beograd
  • Berlin
  • Bern
  • Bhubaneswar
  • Bilbo
  • Billings
  • Bitola
  • Bologna
  • Bratislavský kraj
  • Brest
  • Brighton
  • Bruxelles
  • București
  • Budapest
  • Buenos Aires
  • Buffalo
  • Burgas
  • Burgos
  • Bydgoszcz
  • Caen
  • Cairns North
  • Cairo Governorate
  • Calgary
  • Cali
  • campbelltown
  • Canton
  • Cape Town
  • cascina-perseghetto
  • Castelló de la Plana
  • Cedar Rapids
  • Chaidari
  • chalandri
  • chang-chun-shi
  • chang-sha-shi
  • Changhua County
  • Charleroi
  • Charlotte
  • Chemnitz
  • cheng-du-shi
  • Cheonan
  • cheongju
  • Chernihiv
  • Chernivtsi
  • Chicago
  • Chuo City
  • Chur
  • Cincinnati
  • Cipolletti
  • Ciudad de Guatemala
  • Ciudad de México
  • Cleveland
  • Cluj-Napoca
  • colton
  • Columbus
  • coquimbo
  • Cork
  • Craiova
  • Cranston
  • Culiacán Rosales
  • Cumberland
  • Cáceres
  • Cádiz
  • Córdoba
  • Dakahlia Governorate
  • Dalian
  • Daphne
  • Davao City
  • Debrecen
  • Den Haag
  • dil
  • Donostia
  • dooradoyle
  • Douglas
  • Dublin
  • Dublin 4
  • east-albury
  • Edirne
  • Edmonton
  • Eindhoven
  • El Palmar
  • El Paso
  • Elche
  • Eldoret
  • Elmhurst
  • Epping
  • Erlangen
  • Espírito Santo
  • Essen
  • Flemington
  • Floridablanca
  • Flower Mound
  • Fort Worth
  • Fountain Valley
  • Frankston
  • Fuenlabrada
  • Fukushima
  • Fuzhou
  • Gainesville
  • Galway
  • Gdynia
  • George
  • George Town
  • Georgsmarienhütte
  • Gera
  • Germantown
  • Girona
  • Gliwice
  • Goiás
  • gokul-shirgaon
  • Golden Valley
  • gomez-palacio
  • Goyang-si
  • gqeberha
  • Granada
  • Graz
  • Grenoble
  • groveport
  • Grudziądz
  • Guadalajara
  • guang-zhou-shi
  • guatemala-department
  • Guimaraes
  • Hamburg
  • hang-zhou-shi
  • Hanover
  • Harbin
  • Harrisburg
  • Hefei Shi
  • Helsinki
  • heroica-puebla-de-zaragoza
  • Hershey
  • Hiroshima
  • Hlavní město Praha
  • Hobart
  • Hollywood
  • Hong Kong Island
  • Houston
  • hsinchu-city
  • Huelva
  • hxm
  • Iași
  • Iloilo City
  • Ina
  • Incheon
  • Innsbruck
  • Iowa City
  • Iraklio
  • Isehara
  • İstanbul
  • İzmir
  • Jacksonville
  • Jerez de la Frontera
  • Jesús María
  • Ji Nan Shi
  • jilin-city
  • Johannesburg
  • Joliet
  • Jönköping
  • Kagoshima
  • Kampala
  • Kansas City
  • Kaohsiung City
  • Karlsruhe
  • Kharkiv
  • Kifisia
  • Kladovo
  • Kolkata
  • Koto City
  • Košický kraj
  • Krung Thep Maha Nakhon
  • Kuala Lumpur
  • Kuching
  • Kumamoto
  • Kunming
  • Kurralta Park
  • Kyiv
  • La Laguna
  • La Rioja
  • La Roche-sur-Yon
  • Las Palmas de Gran Canaria
  • Las Vegas
  • Le Mans
  • Leicester
  • Leuven
  • Lexington
  • libramont-chevigny
  • Lille
  • Limoges
  • linyi
  • Linz
  • Lisboa
  • Liverpool
  • Liège
  • Ljubljana
  • Lleida
  • London
  • Long Beach
  • Longmont
  • Longueuil
  • Los Angeles
  • Louisville
  • Loures
  • Lubbock
  • Lublin
  • Lucerne
  • Lucknow
  • luik
  • Luzern
  • Lynchburg
  • Machalí
  • Madison
  • Madrid
  • Mainz
  • Majadahonda
  • Manila
  • Mannheim
  • Manresa
  • Mar del Plata
  • Marousi
  • Marseille
  • McAllen
  • McKinney
  • Meldola
  • Mexicali
  • Miami
  • Miami Beach
  • Milano
  • Milwaukee
  • Minas Gerais
  • Miraflores
  • Miskolc
  • Moncton
  • Monterrey
  • Montería
  • Montpellier
  • Montréal
  • Morgantown
  • Mostar
  • Mumbai
  • Murcia
  • Málaga
  • Mérida
  • Mönchengladbach
  • Nagpur
  • Naha
  • Namur
  • nan-chang-shi
  • nan-ning-shi
  • Nantes
  • Naperville
  • Napoli
  • Nashik
  • Nashville
  • Nedlands
  • negrar-di-valpolicella
  • Neochoropoulo
  • New Brunswick
  • New Orleans
  • New Taipei City
  • New Territories
  • New York
  • Newport Beach
  • Norfolk
  • North Sydney
  • Nottingham
  • oaxaca-de-juarez
  • Odesa
  • olomouc-9
  • Omaha
  • Orange
  • Orlando
  • Osaka
  • Palma
  • Pamplona
  • Panagyurishte
  • panorama
  • Paris
  • Pasig
  • patna
  • Patra
  • Patras
  • Pereira
  • Pergamino
  • Pernambuco
  • petaling-jaya
  • Pimpri-Chinchwad
  • Pireas
  • Pisa
  • Pittsburgh
  • Plainfield
  • Plérin
  • Portland
  • Porto
  • Preston
  • Pretoria
  • Providencia
  • Puerto Montt
  • Pula
  • Pune
  • Putrajaya
  • Quetzaltenango
  • Quezon City
  • Québec
  • Raleigh
  • Rankweil
  • Ravensburg
  • Reggio Emilia
  • Regina
  • Rennes
  • Reus
  • Richmond
  • Ringwood East
  • Rio de Janeiro
  • Rio Grande do Sul
  • Roanoke
  • Roma
  • Rosario
  • Rouen
  • Rīga
  • Sabadell
  • saguenay
  • Saint Albans
  • Saint-Cloud
  • Saint-Jérôme
  • Salzburg
  • Samsun
  • San Antonio
  • San Borja
  • San Carlos de Bariloche
  • San Diego
  • San Isidro
  • San Jose
  • San José
  • San José Province
  • San Juan
  • San Luis Potosí
  • San Miguel de Tucumán
  • San Salvador de Jujuy
  • san-juan-de-alicante
  • Sandton
  • sankt-poelten
  • sankt-veit-an-der-glan
  • Santa Barbara
  • Santa Catarina
  • Santa Rosa
  • Santiago
  • Santiago de Compostela
  • Sapporo
  • Sarajevo
  • Sault Ste. Marie
  • Savannah
  • Schweinfurt
  • Seattle
  • Seongnam-si
  • Seoul
  • Sevilla
  • Shanghai
  • shen-yang-shi
  • shenandoah
  • shepparton
  • Sherbrooke
  • Shijiazhuang
  • shkupi
  • Sioux Falls
  • Skopje
  • skorzewo
  • South Brisbane
  • southwest-finland
  • Split
  • Springfield
  • Sremska Kamenica
  • St. Gallen
  • Stamford
  • Stanford
  • State of São Paulo
  • Steyr
  • Stockholm
  • Stony Brook
  • Strasbourg
  • sundsvall
  • sungai-petani
  • Surat
  • Suwon-si
  • São Paulo
  • T'bilisi
  • Taichung City
  • Tainan City
  • Taipei City
  • Talca
  • Tampere
  • Taoyuan City
  • Tatabánya
  • Tbilisi
  • Tel Aviv-Yafo
  • Thessaloniki
  • thindal
  • Thun
  • tian-jin-shi
  • Timișoara
  • Toluca de Lerdo
  • Torrance
  • Towson
  • Trujillo
  • Tuscany
  • Tuzla
  • Tyler
  • Ulsan
  • Uppsala län
  • Vadodara
  • Valladolid
  • valledupar
  • Vallejo
  • Valparaíso
  • València
  • Vancouver
  • vara_din
  • Velbert
  • Venlo
  • Viedma
  • Vigo
  • Vijayawada
  • Vila Nova de Gaia
  • Vila Real
  • Villejuif
  • Vinnytsia
  • Virginia
  • Västerås
  • Waco
  • warrnambool
  • Warszawa
  • Waterford
  • Wels
  • wendouree
  • Wenzhou
  • Weonju
  • West Reading
  • Westmead
  • Wichita
  • Wien
  • Winston-Salem
  • Winterthur
  • Woolloongabba
  • wu-han-shi
  • Wuhan
  • xi-an-shi
  • xia-men-shi
  • xu-zhou-shi
  • Yvoir
  • Zagreb
  • Zalaegerszeg
  • Zaragoza
  • zheng-zhou-shi
  • Zrenjanin
  • Zürich
  • Ávila
  • Łódź
Trial Identifier:

NCT04961996 2021-000129-28,2023-507172-44-00 GO42784

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04961996,GO42784,2021-000129-28,2023-507172-44-00 Trial Identifier
      Giredestrant, Endocrine Therapy of Physician's Choice, LHRH Agonist, Abemaciclib Treatments
      Early Breast Cancer Condition
      Official Title

      A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Primary Study Inclusion Criteria:

      • Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen
      • Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity
      • Participants must have undergone definitive surgery of their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection [ALND] and/or sentinel lymph node biopsy [SLNB])
      • Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization.
      • Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade ≤2 peripheral neuropathy, arthralgia or other toxicities not considered a safety risk for the participant per the investigator's judgment)
      • Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery
      • Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing (i.e., representative archived formalin-fixed, paraffin-embedded [FFPE] tissue block [preferred] or 15-20 slides containing unstained, freshly cut, serial sections), with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study.
      • Participants with node-positive and node-negative disease are eligible provided they meet additional risk criteria as defined in the protocol
      • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
      • Able and willing to swallow, retain, and absorb oral medication
      • Adequate organ function

      Substudy Inclusion Criteria:

      To be eligible for substudy participation, in addition to meeting the inclusion criteria in the primary protocol, participants must also meet the following modified criteria:

      • Patients who received adjuvant radiotherapy must have completed radiotherapy prior to enrollment, and patients must have recovered (to Grade ≤1) from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment.
      Exclusion Criteria

      Primary Study Exclusion Criteria:

      • Pregnant or breastfeeding, or intending to become pregnant during the study or within 10 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of the endocrine therapy of physician's choice
      • Received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study
      • Receiving or planning to receive a CDK4/6 inhibitor as (neo)adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6 inhibitor therapy prior to randomization is allowed.
      • Active cardiac disease or history of cardiac dysfunction
      • Diagnosed with Stage IV breast cancer
      • A history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible.
      • A history of any other malignancy within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or Stage I uterine cancer
      • Any prior endocrine treatment with selective ER modulators (e.g., tamoxifen), degraders, or aromatase inhibitors. A short course of neoadjuvant or adjuvant endocrine therapy (up to 12 weeks) is allowed.
      • Clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
      • Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
      • Known allergy or hypersensitivity to any of the study drugs or any of their excipients
      • Pre- and perimenopausal participants or male participants who have a known hypersensitivity to LHRH agonists
      • A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism
      • Renal dysfunction that requires dialysis
      • A major surgical procedure unrelated to breast cancer within 28 days prior to randomization
      • A serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening
      • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
      • Unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator

      Substudy Exclusion Criteria:

      Potential participants are excluded from the substudy if any criteria from t\he primary study or the following criteria apply:

      • Prior participation in the GO42784 primary study
      • Received a CDK4/6i as (neo)adjuvant therapy prior to enrollment
      • Treatment with moderate CYP3A inducers, strong CYP3A inducers or strong CYP3A inhibitors within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment

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