Phase
Condition
N/ATreatment
Matched Capivasertib Placebo
Fulvestrant
Abemaciclib
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key inclusion criteria for both phases:
Adult females (pre-/peri-/ and post-menopausal), and adult males.
Histologically confirmed HR+/ HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) per the American Society of Clinical Oncology and College of American Pathologists guideline. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.
Eligible for fulvestrant therapy and at least one of the following: palbociclib, ribociclib, or abemaciclib, as per local investigator assessment. Previous tolerance to specific CDK4/6 inhibitors and dose levels required.
Adequate organ and bone marrow functions.
Consent to provide a mandatory FFPE tumour sample.
Key inclusion criteria only for phase III:
Previous treatment with an ET (tamoxifen, AI, or oral SERD) as a single agent or in combination, with radiological evidence of breast cancer recurrence or progression while on, or within 12 months of, completing a (neo)adjuvant ET regimen.
Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA/AKT1/PTEN status.
Be eligible for fulvestrant and at least one out of palbociclib or ribociclib (depending on the available CDK4/6i options at time of enrolment), as per local investigator assessment.
Have measurable lesion(s) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) or, in the absence of measurable disease, lytic or mixed bone lesions that can be assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
Key exclusion criteria for both phases:
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
Radiotherapy within 2 weeks prior to study treatment initiation.
Major surgery or significant traumatic injury within 4 weeks of the first dose of study treatment.
Persistent toxicities (CTCAE Grade >1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss or peripheral sensory neuropathy) after consultation with the AstraZeneca study physician.
Spinal cord compression, brain metastases or leptomeningeal metastases unless these lesions are definitively treated (eg. radiotherapy, surgery) and clinically stable off steroids for management of symptoms for at least 4 weeks prior to study treatment initiation.
Any of the following cardiac criteria at screening:
(a). Mean resting corrected QT interval (QTcF): (i) Participants to be treated with palbociclib:: QTcF ≥ 470 ms obtained from the average of 3 consecutive (triplicate) ECGs (ii) Participants to be treated with ribociclib: QTcF ≥ 450 ms obtained from the average of 3 consecutive (triplicate) ECGs (iii) Participants to be treated with abemaciclib (Phase Ib only): QTcF ≥ 470 ms obtained from the average of 3 consecutive (triplicate) ECGs (b). Any clinically important abnormalities in cardiac rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block) (c). Any factors that increase the risk of QTc prolongation or risk of arrhythmic events (d). Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥ 2 (e). Uncontrolled hypotension (f) uncontrolled hypertension (g). Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher)
uncontrolled or high grade or symptomatic arrhythmia and atrial fibrillation
Any of these clinically significant abnormalities of glucose metabolism at screening:
. diabetes mellitus type I or type II requiring insulin treatment
. Glycated haemoglobin (HbA1c) ≥ 8.0% (63.9 mmol/mol)
Previous allogeneic bone marrow transplant or solid organ transplant.
Key exclusion criteria for the phase III only:
Any prior treatment with, AKT, PI3K or mTOR inhibitors.
Prior treatment with CDK4/6 inhibitors in the metastatic setting (prior CDK4/6 inhibitors permitted in the adjuvant setting provided there was a CDK4/6i treatment free interval of at least 12 months).
More than 1 line of chemotherapy for metastatic disease.
Any line of endocrine-based therapy for inoperable locally advanced or metastatic disease.
Study Design
Study Description
Connect with a study center
Research Site
Buenos Aires, C1125ABD
ArgentinaActive - Recruiting
Research Site
Caba, C1425
ArgentinaSuspended
Research Site
Chivilcoy, B6620LUD
ArgentinaActive - Recruiting
Research Site
Rosario, 2000
ArgentinaActive - Recruiting
Research Site
Santa Fe, S2002RE
ArgentinaSite Not Available
Research Site
Darlinghurst, 2010
AustraliaActive - Recruiting
Research Site
Miranda, 2228
AustraliaSite Not Available
Research Site
Nedlands, 6009
AustraliaSite Not Available
Research Site
Perth, 6009
AustraliaSite Not Available
Research Site
Wahroonga, 2076
AustraliaActive - Recruiting
Research Site
Waratah, 2298
AustraliaActive - Recruiting
Research Site
Brasschaat, 2930
BelgiumActive - Recruiting
Research Site
Bruxelles, 1200
BelgiumActive - Recruiting
Research Site
Edegem, 2650
BelgiumActive - Recruiting
Research Site
Haine-Saint-Paul, 7100
BelgiumActive - Recruiting
Research Site
Leuven, 3000
BelgiumActive - Recruiting
Research Site
Alfenas, 37130-000
BrazilActive - Recruiting
Research Site
Blumenau, 89010-340
BrazilActive - Recruiting
Research Site
Natal, 59075-740
BrazilActive - Recruiting
Research Site
Porto Alegre, 90035-903
BrazilActive - Recruiting
Research Site
Porto Velho, 76834-899
BrazilActive - Recruiting
Research Site
São Paulo, 04014-002
BrazilActive - Recruiting
Research Site
Taubaté, 12030-200
BrazilActive - Recruiting
Research Site
Teresina, 64049-200
BrazilActive - Recruiting
Research Site
Vitoria, 29043-260
BrazilActive - Recruiting
Research Site
Abbotsford, British Columbia V2S0C2
CanadaActive - Recruiting
Research Site
Kelowna, British Columbia V1Y 5L3
CanadaActive - Recruiting
Research Site
Winnipeg, Manitoba R3E 0V9
CanadaSite Not Available
Research Site
Moncton, New Brunswick E1C 6Z8
CanadaSite Not Available
Research Site
Halifax, Nova Scotia B3H 1V7
CanadaActive - Recruiting
Research Site
Brampton, Ontario L6R 3J7
CanadaActive - Recruiting
Research Site
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Research Site
Sault Ste. Marie, Ontario P6A 2C4
CanadaSite Not Available
Research Site
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Research Site
Sherbrooke, Quebec J1H 5N4
CanadaActive - Recruiting
Research Site
Chicoutimi, G7H 5H6
CanadaActive - Recruiting
Research Site
Montreal, H3T 1E2
CanadaActive - Recruiting
Research Site
Beijing, 100044
ChinaActive - Recruiting
Research Site
Bengbu, 233060
ChinaActive - Recruiting
Research Site
Changchun, 130000
ChinaActive - Recruiting
Research Site
Changsha, 410013
ChinaActive - Recruiting
Research Site
Chengdu, 610041
ChinaActive - Recruiting
Research Site
Chongqing, 400042
ChinaActive - Recruiting
Research Site
Fuzhou, 350011
ChinaSite Not Available
Research Site
Guangzhou, 510062
ChinaActive - Recruiting
Research Site
Hangzhou, 310016
ChinaActive - Recruiting
Research Site
Hefei, 230031
ChinaActive - Recruiting
Research Site
Jinan, 250001
ChinaActive - Recruiting
Research Site
Nanchang, 330006
ChinaActive - Recruiting
Research Site
Nanjing, 210029
ChinaActive - Recruiting
Research Site
Nanning, 530021
ChinaActive - Recruiting
Research Site
Shandong,
ChinaActive - Recruiting
Research Site
Shanghai, 200032
ChinaActive - Recruiting
Research Site
Shenyang, 110016
ChinaActive - Recruiting
Research Site
Urumqi, 830000
ChinaSite Not Available
Research Site
Wuhan, 430060
ChinaActive - Recruiting
Research Site
Xi'an, 710061
ChinaActive - Recruiting
Research Site
Xian, 710100
ChinaActive - Recruiting
Research Site
Xiangyang City, 441000
ChinaActive - Recruiting
Research Site
Xuzhou, 221009
ChinaActive - Recruiting
Research Site
Zhengzhou, 450008
ChinaActive - Recruiting
Research Site
Aalborg, 9000
DenmarkActive - Recruiting
Research Site
Aarhus N, 8200
DenmarkActive - Recruiting
Research Site
Hillerød, 3400
DenmarkActive - Recruiting
Research Site
Odense C, 5000
DenmarkActive - Recruiting
Research Site
Bobigny, 93000
FranceSite Not Available
Research Site
Clermont Ferrand, 63011
FranceSite Not Available
Research Site
Limoges, 87042
FranceSite Not Available
Research Site
Lyon, 69008
FranceSite Not Available
Research Site
Plerin, 22190
FranceSite Not Available
Research Site
Rouen, 76021
FranceSite Not Available
Research Site
St Herblain, 44805
FranceActive - Recruiting
Research Site
Villejuif, 94805
FranceActive - Recruiting
Research Site
Augsburg, 86150
GermanyActive - Recruiting
Research Site
Berlin, 13125
GermanyActive - Recruiting
Research Site
Bottrop, 46236
GermanySite Not Available
Research Site
Dresden, 01307
GermanyActive - Recruiting
Research Site
Erlangen, 91054
GermanySite Not Available
Research Site
Frankfurt, 65929
GermanySite Not Available
Research Site
Frankfurt am Main, 65929
GermanyActive - Recruiting
Research Site
Freiburg, 79106
GermanySite Not Available
Research Site
Georgsmarienhütte, 49124
GermanyActive - Recruiting
Research Site
Hamburg, 20357
GermanyActive - Recruiting
Research Site
Hannover, 30625
GermanyActive - Recruiting
Research Site
Heilbronn, 74078
GermanySite Not Available
Research Site
Kiel, 24105
GermanyActive - Recruiting
Research Site
Leipzig, 04103
GermanyActive - Recruiting
Research Site
Mannheim, 68167
GermanySite Not Available
Research Site
Mönchengladbach, 41061
GermanyActive - Recruiting
Research Site
Münster, 48149
GermanySite Not Available
Research Site
Regensburg, 93053
GermanyActive - Recruiting
Research Site
Stade, 21680
GermanySite Not Available
Research Site
Trier, 54290
GermanySite Not Available
Research Site
Ulm, 89075
GermanyActive - Recruiting
Research Site
Bangalore, 560004
IndiaActive - Recruiting
Research Site
JAipur, 302022
IndiaSite Not Available
Research Site
Jaipur, 302017
IndiaSite Not Available
Research Site
Mohali, 160055
IndiaActive - Recruiting
Research Site
Mysuru, 570017
IndiaActive - Recruiting
Research Site
Nagpur, 440001
IndiaActive - Recruiting
Research Site
New Delhi, 110076
IndiaActive - Recruiting
Research Site
Pondicherry, 605006
IndiaSuspended
Research Site
Vadodara, 391760
IndiaActive - Recruiting
Research Site
Varanasi, 221005
IndiaActive - Recruiting
Research Site
Aviano, 33081
ItalySite Not Available
Research Site
Bologna, 40138
ItalySite Not Available
Research Site
Catanzaro, 88100
ItalySite Not Available
Research Site
Firenze, 50141
ItalyActive - Recruiting
Research Site
Milan, 20141
ItalySite Not Available
Research Site
Milano, 20132
ItalySite Not Available
Research Site
Misterbianco, 95045
ItalySite Not Available
Research Site
Napoli, 80131
ItalySite Not Available
Research Site
Padova, 35128
ItalySite Not Available
Research Site
Prato, 59100
ItalyActive - Recruiting
Research Site
Reggio Emilia, 422122
ItalySite Not Available
Research Site
Roma, 00168
ItalySite Not Available
Research Site
Rozzano, 20089
ItalySite Not Available
Research Site
Chiba-shi, 260-8717
JapanSite Not Available
Research Site
Chuo-ku, 104-0045
JapanActive - Recruiting
Research Site
Hidaka-shi, 350-1298
JapanActive - Recruiting
Research Site
Hirakata-shi, 573-1191
JapanSite Not Available
Research Site
Hiroshima-shi, 730-8518
JapanActive - Recruiting
Research Site
Isehara-shi, 259-1193
JapanActive - Recruiting
Research Site
Kagoshima-shi, 892-0833
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanActive - Recruiting
Research Site
Kyoto-shi, 606-8507
JapanActive - Recruiting
Research Site
Matsuyama-shi, 791-0280
JapanSite Not Available
Research Site
Nagoya-shi, 464-8681
JapanSite Not Available
Research Site
Naha-shi, 901-0154
JapanActive - Recruiting
Research Site
Okayama-shi, 700-8558
JapanSite Not Available
Research Site
Osaka-shi, 541-8567
JapanSite Not Available
Research Site
Ota-shi, 373-8550
JapanSite Not Available
Research Site
Sapporo-shi, 060-8638
JapanSite Not Available
Research Site
Sendai-shi, 980-8574
JapanSite Not Available
Research Site
Shimotsuke-shi, 329-0498
JapanSite Not Available
Research Site
Shinagawa-ku, 142-8666
JapanActive - Recruiting
Research Site
Shinjuku-ku, 162-8655
JapanSite Not Available
Research Site
Suita-shi, 565-0871
JapanActive - Recruiting
Research Site
Takasaki-shi, 370-0829
JapanActive - Recruiting
Research Site
Tsu-shi, 514-8507
JapanActive - Recruiting
Research Site
Yokohama-shi, 241-8515
JapanSite Not Available
Research Site
Goyang-si, 10408
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 06273
Korea, Republic ofActive - Recruiting
Research Site
George Town, 10350
MalaysiaActive - Recruiting
Research Site
Kuala Lumpur, 50586
MalaysiaActive - Recruiting
Research Site
Kuching, 93586
MalaysiaActive - Recruiting
Research Site
Pulau Pinang, 10450
MalaysiaActive - Recruiting
Research Site
Selangor, 62250
MalaysiaActive - Recruiting
Research Site
Bialystok, 15-027
PolandSite Not Available
Research Site
Bydgoszcz, 85-796
PolandSite Not Available
Research Site
Gdańsk, 80-952
PolandSite Not Available
Research Site
Koszalin, 75-581
PolandSite Not Available
Research Site
Kraków, 31-501
PolandSite Not Available
Research Site
Lodz, 91-211
PolandSite Not Available
Research Site
Lublin, 20-090
PolandSite Not Available
Research Site
Rzeszów, 35-326
PolandSite Not Available
Research Site
Warszawa, 02-781
PolandCompleted
Research Site
Łódź, 90-302
PolandSite Not Available
Research Site
Barcelona, 8035
SpainActive - Recruiting
Research Site
Granada, 18014
SpainActive - Recruiting
Research Site
Lérida, 25198
SpainSite Not Available
Research Site
Madrid, 28040
SpainActive - Recruiting
Research Site
Málaga, 29010
SpainActive - Recruiting
Research Site
Pamplona, 31008
SpainActive - Recruiting
Research Site
Santiago de Compostela, 15706
SpainSite Not Available
Research Site
Lund, 221 85
SwedenActive - Recruiting
Research Site
Solna, 17176
SwedenActive - Recruiting
Research Site
Växjö, 35185
SwedenActive - Recruiting
Research Site
Kaohsiung, 83301
TaiwanActive - Recruiting
Research Site
Taichung,
TaiwanActive - Recruiting
Research Site
Tainan, 704
TaiwanActive - Recruiting
Research Site
Taipei, 10002
TaiwanActive - Recruiting
Research Site
Taoyuan, 333
TaiwanActive - Recruiting
Research Site
Bangkok, 10700
ThailandActive - Recruiting
Research Site
Chiang Mai, 50200
ThailandActive - Recruiting
Research Site
Dusit, 10300
ThailandActive - Recruiting
Research Site
Hat Yai, 90110
ThailandActive - Recruiting
Research Site
Khon Kaen, 40002
ThailandActive - Recruiting
Research Site
Lampang, 52000
ThailandActive - Recruiting
Research Site
Ratchathewi, 10400
ThailandActive - Recruiting
Research Site
Ankara, 6100
TurkeyActive - Recruiting
Research Site
Antalya, 07070
TurkeyActive - Recruiting
Research Site
Goztepe Istanbul,
TurkeyActive - Recruiting
Research Site
Karsiyaka, 35575
TurkeyActive - Recruiting
Research Site
Kayseri, 38039
TurkeySite Not Available
Research Site
Malatya, 44280
TurkeyActive - Recruiting
Research Site
Samsun, 55200
TurkeyActive - Recruiting
Research Site
Derry, BT47 6SB
United KingdomActive - Recruiting
Research Site
Guildford, CU2 7XX
United KingdomActive - Recruiting
Research Site
London, SE1 9RT
United KingdomActive - Recruiting
Research Site
Taunton, TA1 5DA
United KingdomActive - Recruiting
Research Site
York, YO21 8HE
United KingdomActive - Recruiting
Research Site
Tucson, Arizona 85719
United StatesActive - Recruiting
Research Site
Fountain Valley, California 92708
United StatesActive - Recruiting
Research Site
Glendale, California 91204
United StatesActive - Recruiting
Research Site
Los Angeles, California 90048
United StatesSite Not Available
Research Site
Napa, California 94558
United StatesSite Not Available
Research Site
Newport Beach, California 92663
United StatesActive - Recruiting
Research Site
San Francisco, California 94158
United StatesActive - Recruiting
Research Site
Santa Barbara, California 93105
United StatesSite Not Available
Research Site
Santa Rosa, California 92805
United StatesActive - Recruiting
Research Site
Aurora, Colorado 80045
United StatesActive - Recruiting
Research Site
New Haven, Connecticut 06510
United StatesActive - Recruiting
Research Site
Newark, Delaware 19713
United StatesActive - Recruiting
Research Site
Quincy, Illinois 62305
United StatesActive - Recruiting
Research Site
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
Research Site
Louisville, Kentucky 40202
United StatesSite Not Available
Research Site
Baton Rouge, Louisiana 70809
United StatesSuspended
Research Site
Covington, Louisiana 70433
United StatesActive - Recruiting
Research Site
Annapolis, Maryland 21401
United StatesActive - Recruiting
Research Site
Baltimore, Maryland 21202
United StatesActive - Recruiting
Research Site
Boston, Massachusetts 02215
United StatesActive - Recruiting
Research Site
Detroit, Michigan 48236
United StatesActive - Recruiting
Research Site
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Research Site
Hannibal, Missouri 63401
United StatesActive - Recruiting
Research Site
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Research Site
Omaha, Nebraska 68130
United StatesActive - Recruiting
Research Site
Camden, New Jersey 08103
United StatesActive - Recruiting
Research Site
Brooklyn, New York 11220
United StatesSite Not Available
Research Site
Mineola, New York 11501
United StatesSite Not Available
Research Site
New York, New York 10016
United StatesSite Not Available
Research Site
Durham, North Carolina 27710
United StatesSite Not Available
Research Site
Gresham, Oregon 97030
United StatesActive - Recruiting
Research Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Research Site
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Research Site
York, Pennsylvania 17403
United StatesSite Not Available
Research Site
Providence, Rhode Island 02903
United StatesSite Not Available
Research Site
Greenville, South Carolina 29607
United StatesActive - Recruiting
Research Site
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
Research Site
Nashville, Tennessee 37203
United StatesActive - Recruiting
Research Site
Dallas, Texas 75246
United StatesActive - Recruiting
Research Site
Fort Worth, Texas 76104
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78229
United StatesActive - Recruiting
Research Site
Falls Church, Virginia 22042
United StatesActive - Recruiting
Research Site
Leesburg, Virginia 20176
United StatesActive - Recruiting
Research Site
Midlothian, Virginia 23114
United StatesActive - Recruiting
Research Site
Norfolk, Virginia 23502
United StatesActive - Recruiting
Research Site
Tacoma, Washington 98405
United StatesActive - Recruiting
Research Site
Hanoi, 100000
VietnamActive - Recruiting
Research Site
Ho Chi Minh, 70000
VietnamActive - Recruiting
Research Site
Ho Chi Minh city, 700000
VietnamActive - Recruiting
Research Site
Vinh, 460000
VietnamActive - Recruiting
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