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JOURNAL ONKOLOGIE – STUDIE

A Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Rekrutierend

NCT-Nummer:
NCT04546009

Studienbeginn:
Oktober 2020

Letztes Update:
12.01.2021

Wirkstoff:
GDC-9545, GDC-9545-matched Placebo, Letrozole, Letrozole-matched Placebo, Palbociclib, LHRH Agonist

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: BO41843 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. Only)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations (3 von 92)

Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
13581 Berlin
(Berlin)
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Klinikum Chemnitz gGmbH; Frauen- und Kinderklinik
09116 Chemnitz
(Sachsen)
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Dres.Andreas Ammon und Dirk Meyer
37073 Göttingen
(Niedersachsen)
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Dres. Andreas Köhler und Roswitha Fuchs
63225 Langen
(Hessen)
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Studienzentrum Onkologie Ravensburg; Onkologie Ravensburg
88212 Ravensburg
(Baden-Württemberg)
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Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
53840 Troisdorf
(Nordrhein-Westfalen)
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Universitätsklinik Tübingen; Frauenklinik
72076 Tübingen
(Baden-Württemberg)
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Marien-Hospital Witten; Frauenklinik Brustzentrum
58452 Witten
(Nordrhein-Westfalen)
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California Cancer Associates for Research & Excellence, Inc.
92069 San Marcos
United StatesRekrutierend» Google-Maps
Rocky Mountain Cancer Center
80218 Denver
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University of Miami; Dept Sylvester Cancer Center
33442 Deerfield Beach
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Florida Cancer Specialists - Fort Myers (Broadway)
33901 Fort Myers
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SCRI Florida Cancer Specialists North; Research Office North Region.
33705 Saint Petersburg
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SCRI Florida Cancer Specialists PAN
32308 Tallahassee
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Northwest Georgia Oncology Centers PC - Marietta
30060 Marietta
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Mercy Medical Center
21202 Baltimore
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Maryland Oncology Hematology; Maryland Oncology Hematology, PA
20902 Silver Spring
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HCA Midwest Division
64132 Kansas City
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St. Vincent Frontier Cancer Center
59101 Billings
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San Juan Oncology Associates
87401 Farmington
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Waverly Hematology Oncology
27518 Cary
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Fairview Hospital; Cleveland Clinic Cancer Center
44111 Cleveland
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The Cleveland Clinic Foundation
44195 Cleveland
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Hillcrest Hospital; Hirsch Cancer Center
44124 Mayfield Heights
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Strongsville Hospital; Cleveland Clinic Cancer Center
44136 Strongsville
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Charleston Oncology, P .A
29414 Charleston
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Sarah Cannon Research Inst.
37203 Nashville
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Texas Oncology-Baylor Sammons Cancer Center
75246 Dallas
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Virginia Oncology Associates
23502 Norfolk
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Northwest Medical Specialties
98405 Tacoma
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University of Wisconsin
53792 Madison
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Hospital de Onc Angel Roffo
1425 Buenos Aires
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Fundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
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Hospital Britanico
C1280AEB Ciudad Autonoma Bs As
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Instituto de Investigaciones Metabolicas (Idim)
C1012AAR Ciudad Autonoma de Buenos Aires
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Hospital Provincial del Centenario
2000 Rosario
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Instituto de Oncología de Rosario
S2000KZE Rosario
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CEMER Centro Medico de Enfermedades Respiratorias
B1602DQD Vicente López
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Calvary Mater Newcastle; Medical Oncology
2298 Waratah
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Princess Alexandra Hospital; Division of Cancer Services
4102 Woolloongabba
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Flinders Medical Centre; Medical Oncology
5042 Bedford Park
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Peter MacCallum Cancer Centre-East Melbourne
3000 Melbourne
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Royal Victoria Regional Health Centre
L4M 6M2 Barrie
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Queen Mary Hospital; Dept of Medicine
Hong Kong
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IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
47014 Meldola
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IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
00144 Roma
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Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
25123 Brescia
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National Hospital Organization Kyushu Cancer Center
811-1395 Fukuoka
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Fukushima Medical University Hospital
960-1295 Fukushima
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Hiroshima City Hiroshima Citizens Hospital
730-8518 Hiroshima
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Kumamoto University Hospital
860-8556 Kumamoto
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National Hospital Organization Osaka National Hospital
540-0006 Osaka
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National Cancer Center Hospital
104-0045 Tokyo
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The Cancer Institute Hospital of JFCR
135-8550 Tokyo
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Auckland City Hospital; Clinical Oncology
1023 Auckland
New ZealandRekrutierend» Google-Maps
Respublikanskiy Onkologicheskiy Dispanser
430032 Saransk
Russian FederationRekrutierend» Google-Maps
Ryazan Regional clinical oncology dispensary
390011 Ryazan
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Chelyabinsk region oncology dispensary
454087 Chelyabinsk
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Podolsk City Clinical Hospital; Hematology
142100 Podolsk
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GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
197758 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Regional Clinical Oncology Hospital
150040 Yaroslavl
Russian FederationRekrutierend» Google-Maps
Hospital Univ Vall d'Hebron; Servicio de Oncologia
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Ramon y Cajal; Servicio de Oncologia
28034 Madrid
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China Medical University Hospital; Surgery
404 Taichung
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National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
704 Tainan
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VETERANS GENERAL HOSPITAL; Department of General Surgery
00112 Taipei
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Chulalongkorn Hospital, Faculty of Medicine; Dept. of Medicine
10330 Bangkok
ThailandRekrutierend» Google-Maps
Rajavithi Hospital; Division of Medical Oncology
10400 Bangkok
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Ramathibodi Hospital; Medicine/Oncology
10400 Bangkok
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Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology
50200 Chang Mai
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Songklanagarind Hospital; Department of Oncology
90110 Songkhla
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Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
22030 Edirne
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Medipol University MF; Oncology Department
34214 Istanbul
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Katip Celebi University Ataturk Training and Research Hospital; Oncology
35360 Izmir
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Kocaeli University Faculty of Medicine; Medical oncology
31380 Izmit
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Medeniyet University Goztepe Training and Research Hospital.
34722 Kadiköy
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Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
44280 Malatya
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Mersin Medical Park Hospital
33200 Mezi̇tli̇
TurkeyRekrutierend» Google-Maps
19 Mayis University Medical Faculty; Medical Oncology Department
55139 Samsun
TurkeyRekrutierend» Google-Maps
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
06230 Sihhiye/Ankara
TurkeyRekrutierend» Google-Maps
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Studien-Informationen

Brief Summary:

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate

the efficacy and safety of GDC-9545 combined with palbociclib compared with letrozole

combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal

growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or

metastatic breast cancer.

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

- No history of systemic anti-cancer therapy for locally advanced (recurrent or

progressed) or metastatic disease

- Measurable disease as defined per RECIST v.1.1

- Eastern Cooperative Oncology Group Performance Status 0-1

- Adequate organ function

Exclusion Criteria:

- Disease recurrence during or within 12 months of completing prior neoadjuvant or

adjuvant treatment with an aromatase inhibitor (AI)

- Disease recurrence during or within 12 months of completing prior neoadjuvant or

adjuvant treatment with any CDK4/6 inhibitor

- Prior treatment with a selective estrogen receptor degrader (SERD)

- Prior treatment with tamoxifen is permitted, provided the patient did not experience

disease recurrence within the first 24 months of treatment with tamoxifen

- Treatment with any investigational therapy within 28 days prior to study treatment

- 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 (PFS), as Determined by the Investigator According to RECIST v1.1 (Time Frame - From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months))



Secondary outcome:

1. Overall Survival (Time Frame - From randomization to death from any cause (up to 78 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 78 months)):
The objective response rate is defined as the percentage of participants with a complete response or partial response 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 78 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 78 months)):
The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response or partial response.

5. Time to Deterioration in Pain Level, 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 78 months))

6. 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 78 months)):
EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire

7. Time to Deterioration in Physical Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 78 months))

8. Time to Deterioration in Role Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score (Time Frame - From Baseline until treatment discontinuation (up to 78 months))

9. 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 78 months))

10. Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) (Time Frame - From treatment initiation until 30 days after the final dose of study treatment (up to 78 months))

11. Number of Participants with Vital Sign Abnormalities Over the Course of the Study (Time Frame - Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days)):
Vital signs include respiratory rate, pulse rate, and systolic and diastolic blood pressure while the participant is in a seated position, and temperature.

12. Plasma Concentration of GDC-9545 at Specified Timepoints (Time Frame - Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days))

13. Plasma Concentration of Palbociclib at Specified Timepoints (Time Frame - Days 1 and 15 of Cycle 1 (1 cycle is 28 days))

Studien-Arme

  • Experimental: GDC-9545 + Letrozole-matched Placebo + Palbociclib
  • Active Comparator: Letrozole + GDC-9545-matched Placebo + Palbociclib

Geprüfte Regime

  • GDC-9545 (Giredestrant / RO7197597 / RG6171 / ):
    GDC-9545 is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • GDC-9545-matched Placebo:
    GDC-9545-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Letrozole:
    Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Letrozole-matched Placebo:
    Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Palbociclib:
    Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.
  • 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


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