JOURNAL ONKOLOGIE – STUDIE
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
Rekrutierend
NCT-Nummer:
NCT04576455
Studienbeginn:
November 2020
Letztes Update:
19.07.2021
Wirkstoff:
Fulvestrant or an Aromatase Inhibitor (Physician's Choice), LHRH Agonist, Giredestrant
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 103)
63739 Aschaffenburg
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
14169 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
20357 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
50935 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
33098 Paderborn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
45659 Recklinghausen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
18439 Stralsund
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
30060 Marietta
United StatesRekrutierend» Google-Maps
60005 Arlington Heights
United StatesRekrutierend» Google-Maps
59101 Billings
United StatesRekrutierend» Google-Maps
44106 Cleveland
United StatesRekrutierend» Google-Maps
97223 Tigard
United StatesRekrutierend» Google-Maps
78731 Austin
United StatesRekrutierend» Google-Maps
79902 El Paso
United StatesRekrutierend» Google-Maps
77024 Houston
United StatesRekrutierend» Google-Maps
75702 Tyler
United StatesRekrutierend» Google-Maps
C1125ABD Buenos Aires
ArgentinaRekrutierend» Google-Maps
1417 Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps
C1012AAR Ciudad Autonoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps
5500 Mendoza
ArgentinaRekrutierend» Google-Maps
S2002KDS Rosario
ArgentinaAktiv, nicht rekrutierend» Google-Maps
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps
2059 North Sydney
AustraliaRekrutierend» Google-Maps
3021 St Albans
AustraliaAktiv, nicht rekrutierend» Google-Maps
6150 Murdoch
AustraliaRekrutierend» Google-Maps
60810-180 Fortaleza
BrazilRekrutierend» Google-Maps
98700-000 Ijui
BrazilRekrutierend» Google-Maps
90050-170 Porto Alegre
BrazilRekrutierend» Google-Maps
01317-001 Sao Paulo
BrazilRekrutierend» Google-Maps
04014-002 Sao Paulo
BrazilRekrutierend» Google-Maps
130021 Changchun City
ChinaRekrutierend» Google-Maps
510060 Guangzhou
ChinaRekrutierend» Google-Maps
150081 Harbin
ChinaRekrutierend» Google-Maps
276034 Linyi City
ChinaRekrutierend» Google-Maps
200120 Shanghai City
ChinaRekrutierend» Google-Maps
300060 Tianjin
ChinaRekrutierend» Google-Maps
430079 Wuhan
ChinaRekrutierend» Google-Maps
710061 Xi'an
ChinaRekrutierend» Google-Maps
310022 Zhejiang
ChinaRekrutierend» Google-Maps
7747629 Ashdod
IsraelRekrutierend» Google-Maps
9112000 Jerusalem
IsraelAktiv, nicht rekrutierend» Google-Maps
4428164 Kfar-Saba
IsraelRekrutierend» Google-Maps
4941492 Petach Tikva
IsraelRekrutierend» Google-Maps
41404 Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
31151 Dongnam-gu, Cheonan-si
Korea, Republic ofRekrutierend» Google-Maps
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
03722 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
06273 Seoul
Korea, Republic ofRekrutierend» Google-Maps
06531 Seoul
Korea, Republic ofRekrutierend» Google-Maps
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
15-027 Bialystok
PolandRekrutierend» Google-Maps
80-219 Gdansk
PolandRekrutierend» Google-Maps
44-102 Gliwice
PolandRekrutierend» Google-Maps
30-688 Kraków
PolandRekrutierend» Google-Maps
02-507 Warszawa
PolandRekrutierend» Google-Maps
02-781 Warszawa
PolandAktiv, nicht rekrutierend» Google-Maps
115478 Moskva
Russian FederationAktiv, nicht rekrutierend» Google-Maps
420029 Kazan
Russian FederationRekrutierend» Google-Maps
350040 Krasnodar
Russian FederationRekrutierend» Google-Maps
660133 Krasnoyarsk
Russian FederationRekrutierend» Google-Maps
183047 Murmansk
Russian FederationRekrutierend» Google-Maps
603081 Nizhny Novgorod
Russian FederationRekrutierend» Google-Maps
197022 Saint-Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps
443011 Samara
Russian FederationRekrutierend» Google-Maps
400138 Volgograd
Russian FederationAktiv, nicht rekrutierend» Google-Maps
150040 Yaroslavl
Russian FederationRekrutierend» Google-Maps
119228 Singapore
SingaporeRekrutierend» Google-Maps
169610 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
9301 Bloemfontein
South AfricaRekrutierend» Google-Maps
6045 Port Elizabeth
South AfricaRekrutierend» Google-Maps
0002 Pretoria
South AfricaRekrutierend» Google-Maps
0081 Pretoria
South AfricaRekrutierend» Google-Maps
500 Changhua
TaiwanRekrutierend» Google-Maps
704 Tainan
TaiwanRekrutierend» Google-Maps
710 Tainan
TaiwanRekrutierend» Google-Maps
00112 Taipei
TaiwanRekrutierend» Google-Maps
333 Taoyuan City
TaiwanRekrutierend» Google-Maps
10330 Bangkok
ThailandRekrutierend» Google-Maps
10400 Bangkok
ThailandAktiv, nicht rekrutierend» Google-Maps
10400 Bangkok
ThailandAktiv, nicht rekrutierend» Google-Maps
50200 Chang Mai
ThailandRekrutierend» Google-Maps
90110 Songkhla
ThailandRekrutierend» Google-Maps
06520 Ankara
TurkeyRekrutierend» Google-Maps
06800 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
07020 Antalya
TurkeyRekrutierend» Google-Maps
21280 Diyarbakir
TurkeyRekrutierend» Google-Maps
34000 Istanbul
TurkeyRekrutierend» Google-Maps
34384 Istanbul
TurkeyRekrutierend» Google-Maps
35360 Izmir
TurkeyRekrutierend» Google-Maps
31380 Izmit
TurkeyRekrutierend» Google-Maps
55200 Samsun
TurkeyRekrutierend» Google-Maps
10007 Zhytomyr
UkraineRekrutierend» Google-Maps
03115 Kyiv
UkraineRekrutierend» Google-Maps
04107 Kyiv
UkraineRekrutierend» Google-Maps
40005 Sumy
UkraineRekrutierend» Google-Maps
EH4 2XU Edinburgh
United KingdomRekrutierend» Google-Maps
CM20 1QX Harlow
United KingdomRekrutierend» Google-Maps
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
SE1 9RT London
United KingdomRekrutierend» Google-Maps
NG5 1PB Nottingham
United KingdomRekrutierend» Google-Maps
PE3 9GZ Peterborough
United KingdomRekrutierend» Google-Maps
Studien-Informationen
Brief Summary:This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and
safety of giredestrant 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 and for 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 Giredestrant 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: Giredestrant
- 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
- Giredestrant (GDC-9545 / RO7197597 / RG6171 / ):
Giredestrant 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/perimenopausal participants 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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