Actively Recruiting
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
Led by Relay Therapeutics, Inc. · Updated on 2026-05-08
540
Participants Needed
158
Research Sites
331 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
CONDITIONS
Official Title
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has ECOG performance status of 0-1
- One or more known primary oncogenic PIK3CA mutation(s)
- Adult females, pre- and/or post-menopausal, and adult males; pre-menopausal women must be treated with a GnRH agonist starting at least 4 weeks before randomization and continue during the study
- Histologically or cytologically confirmed HR+/HER2- locally advanced or metastatic breast cancer with radiological or objective evidence of recurrence or progression; locally advanced disease not amenable to curative surgery
- Measurable disease per RECIST v1.1 or evaluable bone-only disease
- Radiological progression after previous treatment for HR+/HER2- advanced breast cancer with:
- At least 1 and no more than 2 lines of endocrine therapy in the (neo)adjuvant setting with recurrence on or within 12 months of completion, or in the advanced breast cancer setting
- One prior line of CDK4/6 inhibitor therapy in the advanced or adjuvant setting with progression during or within 12 months of completion
- Patients who progressed during or within 12 months of completion of adjuvant CDK4/6 inhibitor and after advanced setting CDK4/6 therapy are not eligible
You will not qualify if you...
- Prior treatment with CDK2 or selective CDK4 inhibitors or investigational therapies targeting cyclin dependent kinases
- Prior treatment with PIK3, AKT, or mTOR inhibitors or agents inhibiting the PIK3/AKT/mTOR pathway
- Prior immunotherapy
- Prior antibody drug conjugates
- Type 1 diabetes, or type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg/dL, or HbA1c ≥ 7.0%
- Clinically significant, uncontrolled cardiovascular disease
- Factors increasing risk of QTc prolongation or arrhythmic events
- Known active uncontrolled or symptomatic CNS metastases requiring ongoing corticosteroids or anticonvulsants
- History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid treatment, or any active interstitial lung disease
- Hypersensitivity to fulvestrant, RLY-2608, capivasertib, or their excipients
- Known activating AKT mutations, loss-of-function PTEN mutations, or loss of PTEN expression causing oncogenic activation downstream of PI3K
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 158 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Actively Recruiting
3
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
Stanford Women's Cancer Center
Palo Alto, California, United States, 94304
Actively Recruiting
6
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
7
University of California San Diego Moores Cancer Center
San Diego, California, United States, 92037
Actively Recruiting
8
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
9
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
Actively Recruiting
10
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, United States, 80504
Actively Recruiting
11
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
12
Medical Oncology Hematology Consultants, P.A.
Newark, Delaware, United States, 19713
Actively Recruiting
13
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
14
AdventHealth
Altamonte Springs, Florida, United States, 32701
Actively Recruiting
15
Florida Cancer Specialists-South
Fort Myers, Florida, United States, 33901
Actively Recruiting
16
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, United States, 32909
Actively Recruiting
17
Rush University Medical Center
Chicago, Illinois, United States, 60607
Actively Recruiting
18
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
19
Community Health Network, Inc
Indianapolis, Indiana, United States, 46250
Actively Recruiting
20
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
21
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
Actively Recruiting
22
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
23
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
24
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
25
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
26
Profound Research LLC
Royal Oak, Michigan, United States, 48073
Actively Recruiting
27
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
28
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39213
Actively Recruiting
29
Washington University School of Medicine- Siteman Cancer Center
St Louis, Missouri, United States, 63108
Actively Recruiting
30
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
31
Renown Health Medical Oncology
Reno, Nevada, United States, 89502
Actively Recruiting
32
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
33
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
34
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
35
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
36
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
37
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
38
Oregon Health & Science University, Knight Cancer Institute
Portland, Oregon, United States, 97210
Actively Recruiting
39
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
40
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Actively Recruiting
41
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
42
Texas Oncology Central/South
Austin, Texas, United States, 78731
Actively Recruiting
43
Texas Oncology DFW
Dallas, Texas, United States, 75246
Actively Recruiting
44
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
45
Houston Methodist Hospital Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
46
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
47
Baylor Scott and White Medical Center
Temple, Texas, United States, 76508
Actively Recruiting
48
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
49
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
50
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
51
University of Wisconsin Carbone Cancer Center- University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
52
Centro Medico Dr. Doreski- Fundacion Respirar
Buenos Aires, Argentina, 1426
Actively Recruiting
53
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
54
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Actively Recruiting
55
Barwon Health
Geelong, Victoria, Australia, 3220
Actively Recruiting
56
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia, 3000
Actively Recruiting
57
Bayside Health (Alfred)
Melbourne, Victoria, Australia, 3004
Actively Recruiting
58
Sunshine Hospital
Saint Albans, Victoria, Australia, 3021
Actively Recruiting
59
Ballarat Oncology & Haematology Clinical Research Fund
Wendouree, Victoria, Australia, 3355
Actively Recruiting
60
Mater Hospital Sydney
North Sydney, Australia, 2060
Actively Recruiting
61
Medical University of Graz
Graz, Austria, 8036
Actively Recruiting
62
Ordensklinikum Linz GmbH
Linz, Austria, 4010
Actively Recruiting
63
LKH Feldkirch, Interne E am LKH Rankweil
Rankweil, Austria, 6830
Actively Recruiting
64
Institut Jules Bordet
Brussels, Belgium, 1070
Actively Recruiting
65
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
66
Centre Hospitalier de l'Ardenne
Libramont, Belgium, 6800
Actively Recruiting
67
CHU-UCL Namur, Site Sainte-Elisabeth
Namur, Belgium, 5000
Actively Recruiting
68
Vitaz
Sint-Niklaas, Belgium, 9100
Actively Recruiting
69
CHR de Verviers site Tourelle
Verviers, Belgium, 4800
Actively Recruiting
70
Centro de Oncologia do ABC- CEON+ Unidade Sao Caetano do Sul
São Caetano do Sul, São Paulo, Brazil, 09541-270
Actively Recruiting
71
Oncolinicas do Brasil Serviços Médicos S.A (Oncocentro)
Belo Horizonte, Brazil, 30360-680
Actively Recruiting
72
Instituto do Câncer do Ceará
Fortaleza, Brazil, 60430-235
Actively Recruiting
73
Oncoclinicas Natal- Centro de Pesquisa Oncology Natal
Natal, Brazil, 59020-505
Actively Recruiting
74
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90020-090
Actively Recruiting
75
Centro Gaúcho Integrado - Hospital Mae de Deus
Porto Alegre, Brazil, 90110-270
Actively Recruiting
76
Associação Hospitalar Moinhos de Vento
Porto Alegre, Brazil, 90560-032
Actively Recruiting
77
Uniao Brasileira de Educacao e Assistencia/ Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil, 90610-000
Actively Recruiting
78
Oncoclinicas Rio de Janeiro S.A.
Rio de Janeiro, Brazil, 22250-905
Actively Recruiting
79
Instituto de Educação Pesquisa e Gestão em Saúde
Rio de Janeiro, Brazil, 22775-001
Actively Recruiting
80
Nucleo de Oncologia da Bahia S.A.
Salvador, Brazil, 40170-110
Actively Recruiting
81
MHAT "Dr. Tota Venkova", AD
Gabrovo, Bulgaria, 5300
Actively Recruiting
82
William Osler Health System- Brampton Civic Hospital
Brampton, Ontario, Canada, L6R 3J7
Actively Recruiting
83
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H8L6
Actively Recruiting
84
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
85
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
86
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Actively Recruiting
87
University Hospital Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
88
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
89
Zealand University Hospital
Næstved, Denmark, 4700
Actively Recruiting
90
Sønderborg Sygehus
Sønderborg, Denmark, 6400
Actively Recruiting
91
L'Institut de Cancérologie de l'Ouest (ICO) - Angers
Angers, France, 49055
Actively Recruiting
92
CHU Besancon
Besançon, France, 25030
Actively Recruiting
93
Centre François Baclesse
Caen, France, 14000
Actively Recruiting
94
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
95
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Actively Recruiting
96
Centre de Cancérologie du Grand Montpellier
Montpellier, France, 34070
Actively Recruiting
97
Hopital du Leman
Thonon-les-Bains, France, 74200
Actively Recruiting
98
Institut Claudius Regaud
Toulouse, France, 31300
Actively Recruiting
99
Marienhospital Bottrop gGmbH
Bottrop, Germany, 46236
Actively Recruiting
100
Studienzentrale für das MVZ Eggenfelden GbR
Eggenfelden, Germany, 84307
Actively Recruiting
101
Praxis fuer Interdisziplinaere Onkologie und Haematologie
Freiburg im Breisgau, Germany, 79110
Actively Recruiting
102
Universitaetsmedizin Mannheim
Mannheim, Germany, 68167
Actively Recruiting
103
University General Hospital of Athens "Attikon"
Athens, Greece, 124 62
Actively Recruiting
104
Iaso Hospital
Athens, Greece, 151 21
Actively Recruiting
105
General University Hospital of Crete
Heraklion, Greece, 715 00
Actively Recruiting
106
University Hospital of Larissa
Larissa, Greece, 41110
Actively Recruiting
107
Interbalkan Hospital of Thessaloniki
Thessaloniki, Greece, 570 01
Actively Recruiting
108
Hong Kong United Oncology Centre
Hong Kong, Hong Kong, HGK
Actively Recruiting
109
Queen Mary Hospital
Hong Kong, Hong Kong, HGK
Actively Recruiting
110
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy, 60126
Actively Recruiting
111
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, Italy, 25123
Actively Recruiting
112
IRCCS Candiolo
Candiolo, Italy, 10060
Actively Recruiting
113
AOU Ferrara, Arcispedale Sant'Anna
Cona, Italy, 44124
Actively Recruiting
114
Azienda Ospedaliera Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
115
Azienda USl Toscana Nord Ovest SC Oncologia Medica Ospedale Civile Livorno
Livorno, Italy, 57124
Actively Recruiting
116
IRCCS Istituto Romagnolo per lo Studio Dei Tumori (IRST) "Dino Amadori"
Meldola, Italy, 47014
Actively Recruiting
117
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
118
Hospital San Giuseppe
Milan, Italy, 50053
Actively Recruiting
119
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Actively Recruiting
120
Maastricht University Medical Center
Maastricht, Netherlands, 6229
Actively Recruiting
121
Radboud UMC
Nijmegen, Netherlands, 6525
Actively Recruiting
122
Zuyderland Medisch Centrum - Heerlen
Sittard, Netherlands, 6419
Actively Recruiting
123
Haga Ziekenhuis
The Hague, Netherlands, 2545
Actively Recruiting
124
Pratia MCM Krakow
Krakow, Poland, 30-727
Actively Recruiting
125
Mruk-Med Sp. z o.o
Rzeszów, Poland, 35-234
Actively Recruiting
126
Hospital da Luz
Lisbon, Portugal, 1500-650
Actively Recruiting
127
Unidade Local de Saude de Loures Odivelas E.P.E. Hospital Beatriz Angelo
Loures, Portugal, 2674-514
Actively Recruiting
128
Raffles Hospital
Singapore, Singapore, 188770
Actively Recruiting
129
Curie Oncology (Farrer)
Singapore, Singapore, 217562
Actively Recruiting
130
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea, 13496
Actively Recruiting
131
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
132
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
133
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
134
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea, 06273
Actively Recruiting
135
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
136
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
137
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
138
Seoul National University Bundang Hospital
Seoul, South Korea, 13620
Actively Recruiting
139
Hospital Universitario de Badajoz
Badajoz, Spain, 06006
Actively Recruiting
140
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
141
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
142
Hospital San Pedro de Alcantara
Cáceres, Spain, 10003
Actively Recruiting
143
Hospital Universitario Virgen de la Arrixaca
El Palmar, Spain, 30120
Actively Recruiting
144
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain, 17007
Actively Recruiting
145
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain, 21005
Actively Recruiting
146
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Actively Recruiting
147
Hospital Beata Maria Ana/IOB Madrid
Madrid, Spain, 28007
Actively Recruiting
148
Clinica Universidad de Navarra
Madrid, Spain, 28027
Actively Recruiting
149
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
150
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Actively Recruiting
151
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain, 38320
Actively Recruiting
152
Instituto Valenciano de Oncologia (IVO)
Valencia, Spain, 46009
Actively Recruiting
153
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
154
Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan, 23561
Actively Recruiting
155
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Actively Recruiting
156
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
157
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
158
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
R
Relay Therapeutics, Inc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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