JOURNAL ONKOLOGIE – STUDIE
A Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Rekrutierend
NCT-Nummer:
NCT04576455
Studienbeginn:
November 2020
Letztes Update:
11.01.2021
Wirkstoff:
GDC-9545, Fulvestrant or an Aromatase Inhibitor (Physician's Choice), LHRH Agonist
Indikation (Clinical Trials):
Breast Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
Hoffmann-La Roche
Collaborator:
-
Studienleiter
Study Director
Hoffmann-La Roche
Kontakt
Kontakt:
Phone: 888-662-6728 (U.S. Only)
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen
Studienlocations (3 von 39)
Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
63739 Aschaffenburg
(Bayern)
GermanyRekrutierend» Google-MapsFrauenarzt-Zentrum Zehlendorf an der Teltower Eiche
14169 Berlin
(Berlin)
GermanyRekrutierend» Google-MapsKooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
20357 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
63739 Aschaffenburg
(Bayern)
GermanyRekrutierend» Google-MapsFrauenarzt-Zentrum Zehlendorf an der Teltower Eiche
14169 Berlin
(Berlin)
GermanyRekrutierend» Google-MapsKooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
20357 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
St. Elisabeth-Krankenhaus; Brustzentrum
50935 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsSt. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
33098 Paderborn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsOncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsgSUND Gynäkologie Kompetenzzentrum Stralsund; Frauenheilkunde & Geburtshilfe
18435 Stralsund
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-MapsNorthwest Georgia Oncology Centers PC - Marietta
30060 Marietta
United StatesRekrutierend» Google-MapsIllinois Cancer Specialists
60005 Arlington Heights
United StatesRekrutierend» Google-MapsSt. Vincent Frontier Cancer Center
59101 Billings
United StatesRekrutierend» Google-MapsNorthwest Cancer Specialists - Portland (SW Barnes Rd)
97223 Tigard
United StatesRekrutierend» Google-MapsTexas Oncology Cancer Center
78731 Austin
United StatesRekrutierend» Google-MapsTexas Oncology - El Paso
79902 El Paso
United StatesRekrutierend» Google-MapsTexas Oncology - Houston (Gessner)
77024 Houston
United StatesRekrutierend» Google-MapsFundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
ArgentinaRekrutierend» Google-MapsInstituto de Investigaciones Metabolicas (Idim)
C1012AAR Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» Google-MapsSunshine Hospital
3021 St Albans
AustraliaRekrutierend» Google-MapsHospital de Caridade de Ijui; Oncologia
98700-000 Ijui
BrazilRekrutierend» Google-MapsRabin Medical Center; Oncology Dept
4941492 Petach Tikva
IsraelRekrutierend» Google-MapsKyungpook National University Medical Center
41404 Daegu
Korea, Republic ofRekrutierend» Google-MapsSoon Chun Hyang University Cheonan Hospital
31151 Dongnam-gu, Cheonan-si
Korea, Republic ofRekrutierend» Google-MapsNational Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center
(0)6351 Seoul
Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-MapsGangnam Severance Hospital
06273 Seoul
Korea, Republic ofRekrutierend» Google-MapsRepublican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
420029 Kazan
Russian FederationRekrutierend» Google-MapsClinical Oncology Centre # 1; Chemotherapy Dept
350040 Krasnodar
Russian FederationRekrutierend» Google-MapsKrasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
660133 Krasnoyarsk
Russian FederationRekrutierend» Google-MapsBlokhin Cancer Research Center; Combined Treatment
115478 Moscow
Russian FederationRekrutierend» Google-MapsMurmansk Regional Clinical Hospital named after P.A. Bayandin
183047 Murmansk
Russian FederationRekrutierend» Google-MapsRegional Clinical Oncology Hospital
150040 Yaroslavl
Russian FederationRekrutierend» Google-MapsIatros International
9301 Bloemfontein
South AfricaRekrutierend» Google-MapsCancercare Langenhoven Drive Oncology Centre
6045 Port Elizabeth
South AfricaRekrutierend» Google-MapsEastleigh Breast Care Centre
0081 Pretoria
South AfricaRekrutierend» Google-MapsVETERANS GENERAL HOSPITAL; Department of General Surgery
00112 Taipei
TaiwanRekrutierend» Google-MapsChulalongkorn Hospital; Medical Oncology
10330 Bangkok
ThailandRekrutierend» Google-MapsMaharaj Nakorn Chiang Mai Hosp; Surgery/Oncology
50200 Chang Mai
ThailandRekrutierend» Google-Maps
Alle anzeigen 50935 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsSt. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
33098 Paderborn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsOncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsgSUND Gynäkologie Kompetenzzentrum Stralsund; Frauenheilkunde & Geburtshilfe
18435 Stralsund
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-MapsNorthwest Georgia Oncology Centers PC - Marietta
30060 Marietta
United StatesRekrutierend» Google-MapsIllinois Cancer Specialists
60005 Arlington Heights
United StatesRekrutierend» Google-MapsSt. Vincent Frontier Cancer Center
59101 Billings
United StatesRekrutierend» Google-MapsNorthwest Cancer Specialists - Portland (SW Barnes Rd)
97223 Tigard
United StatesRekrutierend» Google-MapsTexas Oncology Cancer Center
78731 Austin
United StatesRekrutierend» Google-MapsTexas Oncology - El Paso
79902 El Paso
United StatesRekrutierend» Google-MapsTexas Oncology - Houston (Gessner)
77024 Houston
United StatesRekrutierend» Google-MapsFundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
ArgentinaRekrutierend» Google-MapsInstituto de Investigaciones Metabolicas (Idim)
C1012AAR Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» Google-MapsSunshine Hospital
3021 St Albans
AustraliaRekrutierend» Google-MapsHospital de Caridade de Ijui; Oncologia
98700-000 Ijui
BrazilRekrutierend» Google-MapsRabin Medical Center; Oncology Dept
4941492 Petach Tikva
IsraelRekrutierend» Google-MapsKyungpook National University Medical Center
41404 Daegu
Korea, Republic ofRekrutierend» Google-MapsSoon Chun Hyang University Cheonan Hospital
31151 Dongnam-gu, Cheonan-si
Korea, Republic ofRekrutierend» Google-MapsNational Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center
(0)6351 Seoul
Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-MapsGangnam Severance Hospital
06273 Seoul
Korea, Republic ofRekrutierend» Google-MapsRepublican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
420029 Kazan
Russian FederationRekrutierend» Google-MapsClinical Oncology Centre # 1; Chemotherapy Dept
350040 Krasnodar
Russian FederationRekrutierend» Google-MapsKrasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
660133 Krasnoyarsk
Russian FederationRekrutierend» Google-MapsBlokhin Cancer Research Center; Combined Treatment
115478 Moscow
Russian FederationRekrutierend» Google-MapsMurmansk Regional Clinical Hospital named after P.A. Bayandin
183047 Murmansk
Russian FederationRekrutierend» Google-MapsRegional Clinical Oncology Hospital
150040 Yaroslavl
Russian FederationRekrutierend» Google-MapsIatros International
9301 Bloemfontein
South AfricaRekrutierend» Google-MapsCancercare Langenhoven Drive Oncology Centre
6045 Port Elizabeth
South AfricaRekrutierend» Google-MapsEastleigh Breast Care Centre
0081 Pretoria
South AfricaRekrutierend» Google-MapsVETERANS GENERAL HOSPITAL; Department of General Surgery
00112 Taipei
TaiwanRekrutierend» Google-MapsChulalongkorn Hospital; Medical Oncology
10330 Bangkok
ThailandRekrutierend» Google-MapsMaharaj Nakorn Chiang Mai Hosp; Surgery/Oncology
50200 Chang Mai
ThailandRekrutierend» Google-Maps
Studien-Informationen
Brief Summary:This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and
safety of GDC-9545 compared with physician's choice of endocrine monotherapy in participants
with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2
(HER2)-negative locally advanced or metastatic breast cancer who have received one or two
prior lines of systemic therapy in the locally advanced (recurrent or progressed) or
metastatic setting.
Ein-/Ausschlusskriterien
Inclusion Criteria:- For women who are premenopausal or perimenopausal or men: treatment with approved LHRH
agonist therapy for the duration of study treatment
- Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast,
not amenable to treatment with curative intent
- Documented ER-positive tumor and HER2-negative tumor, assessed locally
- Disease progression after treatment with one or two lines of systemic therapy (but not
more than one prior targeted therapy) in the locally advanced (recurrent or
progressed) or metastatic setting
- Measurable disease as defined per RECIST v.1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Adequate organ function
Exclusion Criteria:
- Prior treatment with a selective estrogen receptor degrader (SERD), with the exception
of fulvestrant
- Treatment with any investigational therapy within 28 days prior to randomization
- Advanced, symptomatic, visceral spread that is at risk of life-threatening
complications
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or
leptomeningeal disease
- Active cardiac disease or history of cardiac dysfunction
- Pregnant or breastfeeding
Studien-Rationale
Primary outcome:1. Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (Time Frame - From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 40 months))
Secondary outcome:
1. Overall Survival (Time Frame - From randomization to death from any cause (up to 40 months))
2. Objective Response Rate, as Determined by the Investigator According to RECIST v1.1 (Time Frame - From randomization until disease progression or death (up to 40 months)):
The objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions at least 4 weeks apart.
3. Duration of Response, as Determined by the Investigator According to RECIST v1.1 (Time Frame - From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 40 months))
4. Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1 (Time Frame - From randomization until disease progression or death (up to 40 months)):
The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response (CR) or partial response (PR).
5. Investigator-Assessed Progression-Free Survival, in Subgroups Categorized by ESR1 Mutation Status (Time Frame - From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 40 months))
6. Time to Deterioration in Pain Severity, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the "Worst Pain" Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire (Time Frame - From Baseline until treatment discontinuation (up to 40 months))
7. Time to Deterioration in Pain Presence and Interference, Defined as the Time to First Documented ≥10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 40 months)):
EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30
8. Time to Deterioration in Physical Functioning (PF), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed PF Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 40 months))
9. Time to Deterioration in Role Functioning (RF), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed RF Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 40 months))
10. Time to Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 40 months))
11. Number of Participants with Adverse Events, Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) (Time Frame - From Baseline until 30 days after final dose of study drug (up to 40 months))
12. Number of Participants with Vital Sign Abnormalities Over the Course of the Study (Time Frame - Assessed at Baseline and predose on Day 1 of every cycle (1 cycle is 28 days) until 30 days after the final dose of study drug (up to 40 months)):
Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure while the patient is in a seated position, and temperature.
13. Number of Participants with Clinical Laboratory Test Abnormalities for Hematology Parameters Over the Course of the Study (Time Frame - Assessed at Baseline and predose on Day 1 of every cycle (1 cycle is 28 days) until 30 days after the final dose of study drug (up to 40 months))
14. Number of Participants with Clinical Laboratory Test Abnormalities for Biochemistry Parameters Over the Course of the Study (Time Frame - Assessed at Baseline and predose on Day 1 of every cycle (1 cycle is 28 days) until 30 days after the final dose of study drug (up to 40 months))
15. Plasma Concentration of GDC-9545 at Specified Timepoints (Time Frame - Predose and postdose on Day 1 of Cycles 1 and 2, predose on Day 1 of Cycles 3, 5, 7, 9, 11, 13, and 15 (1 cycle is 28 days), and 30 days after final dose of study drug (up to 40 months))
Studien-Arme
- Experimental: GDC-9545
- Active Comparator: Physician's Choice of Endocrine Monotherapy
The physician's choice of endocrine monotherapy will be limited to fulvestrant or an aromatase inhibitor.
Geprüfte Regime
- GDC-9545 (Giredestrant / RO7197597 / RG6171 / ):
GDC-9545 is taken orally once per day on Days 1-28 of each 28-day cycle. - Fulvestrant or an Aromatase Inhibitor (Physician's Choice):
Physician's choice of endocrine monotherapy (fulvestrant or an aromatase inhibitor) is taken in accordance with the local prescribing information for the respective product. - LHRH Agonist:
Only premenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Quelle: ClinicalTrials.gov