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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

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: WO42312 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 39)

Hämato-Onkologische Schwerpunktpraxis am Klinikum Aschaffenburg
63739 Aschaffenburg
(Bayern)
GermanyRekrutierend» Google-Maps
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
14169 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
20357 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
St. Elisabeth-Krankenhaus; Brustzentrum
50935 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik
33098 Paderborn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
gSUND Gynäkologie Kompetenzzentrum Stralsund; Frauenheilkunde & Geburtshilfe
18435 Stralsund
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Northwest Georgia Oncology Centers PC - Marietta
30060 Marietta
United StatesRekrutierend» Google-Maps
Illinois Cancer Specialists
60005 Arlington Heights
United StatesRekrutierend» Google-Maps
St. Vincent Frontier Cancer Center
59101 Billings
United StatesRekrutierend» Google-Maps
Northwest Cancer Specialists - Portland (SW Barnes Rd)
97223 Tigard
United StatesRekrutierend» Google-Maps
Texas Oncology Cancer Center
78731 Austin
United StatesRekrutierend» Google-Maps
Texas Oncology - El Paso
79902 El Paso
United StatesRekrutierend» Google-Maps
Texas Oncology - Houston (Gessner)
77024 Houston
United StatesRekrutierend» Google-Maps
Fundación CENIT para la Investigación en Neurociencias
C1125ABD Buenos Aires
ArgentinaRekrutierend» Google-Maps
Instituto de Investigaciones Metabolicas (Idim)
C1012AAR Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps
Hospital de Caridade de Ijui; Oncologia
98700-000 Ijui
BrazilRekrutierend» Google-Maps
Rabin Medical Center; Oncology Dept
4941492 Petach Tikva
IsraelRekrutierend» Google-Maps
Kyungpook National University Medical Center
41404 Daegu
Korea, Republic ofRekrutierend» Google-Maps
Soon Chun Hyang University Cheonan Hospital
31151 Dongnam-gu, Cheonan-si
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
(0)6351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Gangnam Severance Hospital
06273 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
420029 Kazan
Russian FederationRekrutierend» Google-Maps
Clinical Oncology Centre # 1; Chemotherapy Dept
350040 Krasnodar
Russian FederationRekrutierend» Google-Maps
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy
660133 Krasnoyarsk
Russian FederationRekrutierend» Google-Maps
Blokhin Cancer Research Center; Combined Treatment
115478 Moscow
Russian FederationRekrutierend» Google-Maps
Murmansk Regional Clinical Hospital named after P.A. Bayandin
183047 Murmansk
Russian FederationRekrutierend» Google-Maps
Regional Clinical Oncology Hospital
150040 Yaroslavl
Russian FederationRekrutierend» Google-Maps
Iatros International
9301 Bloemfontein
South AfricaRekrutierend» Google-Maps
Cancercare Langenhoven Drive Oncology Centre
6045 Port Elizabeth
South AfricaRekrutierend» Google-Maps
Eastleigh Breast Care Centre
0081 Pretoria
South AfricaRekrutierend» Google-Maps
VETERANS GENERAL HOSPITAL; Department of General Surgery
00112 Taipei
TaiwanRekrutierend» Google-Maps
Chulalongkorn Hospital; Medical Oncology
10330 Bangkok
ThailandRekrutierend» Google-Maps
Maharaj Nakorn Chiang Mai Hosp; Surgery/Oncology
50200 Chang Mai
ThailandRekrutierend» Google-Maps
Alle anzeigen

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


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