Advanced Breast CancerPhase 3EvoPAR-BR01NCT06380751

Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

A Phase 3 study testing Saruparib (AZD5305), Camizestrant and Abemaciclib in people with Advanced Breast Cancer, run by AstraZeneca at 306 sites in 29 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Breast Cancer
What is being tested?: Saruparib (AZD5305), Camizestrant and Abemaciclib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 788 participants
Where: 306 sitesin 29 countries
Study dates: 1 Aug 2024to 30 Dec 2031
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease
ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
FFPE tumour tissue from each participant
Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2
Adequate organ and marrow function

Who cannot join

Participants with history of MDS/AML or with features suggestive of MDS/AML
Participants with any known predisposition to bleeding
Any history of persisting severe cytopenia
Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection
History of another primary malignancy

Show all 29Show fewer

Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia
Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease
Evidence of active and uncontrolled hepatitis B and/or hepatitis C
Evidence of active and uncontrolled HIV infection
Active tuberculosis infection
Cardiac criteria, including history of arrythmia and cardiovascular disease
Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment
Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET for up to 28 days total before randomisation
Prior treatment within 28 days with blood product support or growth factor support
Any systemic concurrent anti-cancer treatment
Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:
Strong and moderate CYP3A4 inducers/inhibitors
Sensitive CYP2B6 substrates
Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.
Concomitant use of drugs that are known to prolong QT and have a known risk of TdP
Systemic use of atropine
The following exclusion criteria apply to treatments administered for early breast cancer:
Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.

Trial locations and contacts

306 sites in 29 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

306 sites in 29 countries

United States61 sites, 41 recruiting

Research Site
Arlington Heights, Illinois, 60005
Recruiting
Research Site
Aurora, Colorado, 80045
Recruiting
Research Site
Baltimore, Maryland, 21201
Recruiting
Research Site
Boston, Massachusetts, 02215
Recruiting
Research Site
Boston, Massachusetts, 02215
Withdrawn
Research Site
Brooklyn, New York, 11220
Withdrawn
Research Site
Camden, New Jersey, 08103
Recruiting
Research Site
Chattanooga, Tennessee, 37404
Recruiting
Research Site
Chicago, Illinois, 60611
Recruiting
Research Site
Dearborn, Michigan, 48126
Withdrawn
Research Site
Detroit, Michigan, 48202
Withdrawn
Research Site
Evanston, Illinois, 60201
Recruiting
Research Site
Fountain Valley, California, 92708
Recruiting
Research Site
Gilbert, Arizona, 85234
Recruiting
Research Site
Glendale, California, 91206
Recruiting
Research Site
Grand Junction, Colorado, 81501
Withdrawn
Research Site
Hershey, Pennsylvania, 17033
Recruiting
Research Site
Hollywood, Florida, 33021
Recruiting
Research Site
Houston, Texas, 77030
Not yet recruiting
Research Site
Houston, Texas, 77030
Recruiting
Research Site
Houston, Texas, 77054
Recruiting
Research Site
Indianapolis, Indiana, 46227
Withdrawn
Research Site
Jacksonville, Florida, 32224
Recruiting
Research Site
Los Angeles, California, 90089
Recruiting
Research Site
Louisville, Kentucky, 40207
Withdrawn
Research Site
Midlothian, Virginia, 23114
Not yet recruiting
Research Site
Milwaukee, Wisconsin, 53215
Withdrawn
Research Site
Mineola, New York, 11501
Recruiting
Research Site
Morgantown, West Virginia, 26506
Recruiting
Research Site
Nashville, Tennessee, 37203
Recruiting
Research Site
New Brunswick, New Jersey, 08901
Withdrawn
Research Site
New Hyde Park, New York, 11042
Withdrawn
Research Site
New York, New York, 10016
Recruiting
Research Site
New York, New York, 10028
Withdrawn
Research Site
New York, New York, 10065
Recruiting
Research Site
Newport Beach, California, 92663
Recruiting
Research Site
Norfolk, Virginia, 23502
Recruiting
Research Site
Orlando, Florida, 32806
Withdrawn
Research Site
Orlando, Florida, 32806
Not yet recruiting
Research Site
Park Ridge, Illinois, 60068
Withdrawn
Research Site
Philadelphia, Pennsylvania, 19104
Recruiting
Research Site
Pittsburgh, Pennsylvania, 15212
Suspended
Research Site
Pittsburgh, Pennsylvania, 15215
Recruiting
Research Site
Rochester, Minnesota, 55905
Recruiting
Research Site
Royal Oak, Michigan, 48073
Withdrawn
Research Site
Royal Oak, Michigan, 48073
Recruiting
Research Site
Saint Joseph, Missouri, 64507
Recruiting
Research Site
San Antonio, Texas, 78240
Recruiting
Research Site
Schaumburg, Illinois, 60173
Not yet recruiting
Research Site
Shirley, New York, 11967
Withdrawn
Research Site
Silver Spring, Maryland, 20902
Withdrawn
Research Site
Silver Spring, Maryland, 20904
Recruiting
Research Site
Springfield, Missouri, 65804
Recruiting
Research Site
St Louis, Missouri, 63110
Not yet recruiting
Research Site
Stony Brook, New York, 11790
Recruiting
Research Site
Tacoma, Washington, 98405
Recruiting
Research Site
The Bronx, New York, 10469
Withdrawn
Research Site
Urbana, Illinois, 61801
Recruiting
Research Site
West Columbia, South Carolina, 29169
Withdrawn
Research Site
Westbury, New York, 11590
Withdrawn
Research Site
Winfield, Illinois, 60190
Recruiting

Other trials in United States

China42 sites, 40 recruiting

Research Site
Beijing, 100044
Recruiting
Research Site
Bengbu, 233004
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Research Site
Changchun, 130012
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Research Site
Changchun, 130021
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Research Site
Changsha, 410008
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Research Site
Changsha, 410013
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Research Site
Chengdu, 610000
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Research Site
Chengdu, 610072
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Research Site
Chongqing, 400042
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Research Site
Foshan, 528000
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Research Site
Fuzhou, 350014
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Research Site
Guangzhou, 510060
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Research Site
Guangzhou, 510062
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Research Site
Guangzhou, 510289
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Research Site
Hangzhou, 310016
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Research Site
Hangzhou, 310022
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Research Site
Harbin, 150081
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Research Site
Hefei, 230031
Recruiting
Research Site
Hohhot, 010017
Withdrawn
Research Site
Jining, 272029
Recruiting
Research Site
Kunming, 650118
Recruiting
Research Site
Liuzhou, 545006
Recruiting
Research Site
Luoyang, 471000
Recruiting
Research Site
Nanchang, 330006
Withdrawn
Research Site
Nanchang, 330009
Recruiting
Research Site
Nanjing, 210029
Recruiting
Research Site
Shandong, 250117
Recruiting
Research Site
Shanghai, 200025
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Research Site
Shanghai, 200120
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Research Site
Shenyang, 110016
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Research Site
Shijiazhuang, 050000
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Research Site
Tianjin, 300000
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Research Site
Weifang, 261000
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Research Site
Wuhan, 430030
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Research Site
Wuhan, 430040
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Research Site
Wuhan, 430079
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Research Site
Xi'an, 710006
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Research Site
Xi'an, 710061
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Research Site
Xiamen, 361003
Recruiting
Research Site
Xiangyang, 441000
Recruiting
Research Site
Xinxiang, 453100
Recruiting
Research Site
Zhengzhou, 450008
Recruiting

Other trials in China

Japan23 sites, 23 recruiting

Research Site
Chiba, 260-8717
Recruiting
Research Site
Hidaka-shi, 350-1298
Recruiting
Research Site
Hirakata-shi, 573-1191
Recruiting
Research Site
Isehara-shi, 259-1193
Recruiting
Research Site
Kagoshima, 892-0833
Recruiting
Research Site
Kashiwa, 227-8577
Recruiting
Research Site
Kōtoku, 135-8550
Recruiting
Research Site
Kumamoto, 860-8556
Recruiting
Research Site
Kyoto, 606-8507
Recruiting
Research Site
Matsuyama, 791-0280
Recruiting
Research Site
Nagoya, 464-8681
Recruiting
Research Site
Nagoya, 466-8560
Recruiting
Research Site
Nagoya, 467-8602
Recruiting
Research Site
Osaka, 541-8567
Recruiting
Research Site
Ota-shi, 373-8550
Recruiting
Research Site
Sapporo, 003-0804
Recruiting
Research Site
Sendai, 980-8574
Recruiting
Research Site
Shinagawa-ku, 142-8666
Recruiting
Research Site
Suita-shi, 565-0871
Recruiting
Research Site
Sunto-gun, 411-8777
Recruiting
Research Site
Takasaki-shi, 370-0829
Recruiting
Research Site
Tsu, 514-8507
Recruiting
Research Site
Yokohama, 241-8515
Recruiting

Other trials in Japan

Germany17 sites, 15 recruiting

Research Site
Aachen, 52074
Recruiting
Research Site
Augsburg, 86150
Withdrawn
Research Site
Berlin, 13125
Recruiting
Research Site
Cologne, 50937
Withdrawn
Research Site
Dessau, 06847
Recruiting
Research Site
Düsseldorf, 40225
Recruiting
Research Site
Erlangen, 91054
Recruiting
Research Site
Göttingen, DE-37099
Recruiting
Research Site
Hamburg, 20357
Recruiting
Research Site
Hanover, 30625
Recruiting
Research Site
Heidelberg, 69120
Recruiting
Research Site
Kiel, 24105
Recruiting
Research Site
Leipzig, 04103
Recruiting
Research Site
Ludwigsburg, 71640
Recruiting
Research Site
München, 81675
Recruiting
Research Site
Münster, 48149
Recruiting
Research Site
Witten, 58452
Not yet recruiting

Other trials in Germany

Spain12 sites, 9 recruiting

Research Site
A Coruña, 15009
Not yet recruiting
Research Site
Barcelona, 08035
Recruiting
Research Site
Cáceres, 10003
Withdrawn
Research Site
Granada, 18007
Recruiting
Research Site
L'Hospitalet de Llobregat, 08908
Recruiting
Research Site
Madrid, 28040
Recruiting
Research Site
Madrid, 28041
Recruiting
Research Site
Málaga, 29010
Recruiting
Research Site
Pamplona, 31008
Withdrawn
Research Site
Seville, 41013
Recruiting
Research Site
Valencia, 46006
Recruiting
Research Site
Zaragoza, 50009
Withdrawn

Other trials in Spain

India11 sites, 9 recruiting

Research Site
Delhi, 110029
Recruiting
Research Site
Kolkata, 700160
Withdrawn
Research Site
Lucknow, 226003
Withdrawn
Research Site
Mumbai, 400012
Recruiting
Research Site
Mumbai, 400052
Recruiting
Research Site
Mysuru, 570017
Recruiting
Research Site
Nagpur, 440001
Recruiting
Research Site
Nashik, 422002
Recruiting
Research Site
New Delhi, 110085
Recruiting
Research Site
Surat, 396007
Recruiting
Research Site
Thiruvananthapuram, 695011
Recruiting

Other trials in India

Brazil10 sites, 10 recruiting

Research Site
Cachoeira de Itapemirim, 29308-055
Recruiting
Research Site
Curitiba, 80060-900
Recruiting
Research Site
Fortaleza, 60336-045
Recruiting
Research Site
Goiânia, 74000-000
Recruiting
Research Site
Jaú, 17210-120
Recruiting
Research Site
Porto Alegre, 91350-200
Recruiting
Research Site
Ribeirão Preto, 14049-901
Recruiting
Research Site
Salvador, 41253-190
Recruiting
Research Site
São Paulo, 01509-900
Recruiting
Research Site
São Paulo, 03102-002
Recruiting

Other trials in Brazil

France10 sites, 9 recruiting

Research Site
Angers, 49100
Recruiting
Research Site
Besançon, 25030
Suspended
Research Site
Lille, 59000
Recruiting
Research Site
Lyon, 69373
Recruiting
Research Site
Marseille, 13273
Recruiting
Research Site
Paris, 75005
Recruiting
Research Site
Rouen, 76021
Recruiting
Research Site
Saint-Herblain, 44805
Recruiting
Research Site
Toulouse, 31059
Recruiting
Research Site
Villejuif, 94805
Recruiting

Other trials in France

Italy10 sites, 9 recruiting

Research Site
Bergamo, 24127
Recruiting
Research Site
Bologna, 40138
Recruiting
Research Site
Milan, 20132
Recruiting
Research Site
Milan, 20141
Recruiting
Research Site
Modena, 41124
Withdrawn
Research Site
Naples, 80131
Recruiting
Research Site
Padova, 35128
Recruiting
Research Site
Reggio Emilia, 422122
Recruiting
Research Site
Rome, 00168
Recruiting
Research Site
Rozzano, 20089
Recruiting

Other trials in Italy

Poland8 sites, 6 recruiting

Research Site
Biała Podlaska, 21-500
Withdrawn
Research Site
Koszalin, 75-581
Recruiting
Research Site
Lodz, 93-338
Recruiting
Research Site
Lublin, 20-090
Recruiting
Research Site
Poznan, 60-569
Recruiting
Research Site
Poznan, 61-485
Withdrawn
Research Site
Radom, 26-600
Not yet recruiting
Research Site
Warsaw, 02-781
Recruiting

Other trials in Poland

South Korea8 sites, 8 recruiting

Research Site
Daegu, 41404
Recruiting
Research Site
Seongnam-si, 13620
Recruiting
Research Site
Seoul, 02841
Recruiting
Research Site
Seoul, 03080
Recruiting
Research Site
Seoul, 06273
Recruiting
Research Site
Seoul, 06351
Recruiting
Research Site
Seoul, 3722
Recruiting
Research Site
Seoul, 5505
Recruiting

Other trials in South Korea

United Kingdom8 sites, 6 recruiting

Research Site
Cambridge, CB2 2QQ
Recruiting
Research Site
Guildford, GU2 7XX
Recruiting
Research Site
London, SE1 9RT
Recruiting
Research Site
Manchester, M20 4BX
Recruiting
Research Site
Oxford, OX3 7LE
Withdrawn
Research Site
Swansea, SA2 8QA
Withdrawn
Research Site
Taunton, TA1 5DA
Recruiting
Research Site
Truro, TR1 3LJ
Recruiting

Other trials in United Kingdom

Argentina7 sites, 6 recruiting

Research Site
Ciudad Autónoma Buenos Aires, 1125
Recruiting
Research Site
Ciudad de Buenos Aires, 1015
Recruiting
Research Site
Ciudad de Buenos Aires, C1280AEB
Recruiting
Research Site
Córdoba, 5008
Recruiting
Research Site
Rosario, S2000KZE
Recruiting
Research Site
Salta, A4400EMI
Recruiting
Research Site
San Miguel de Tucumán, 4000
Withdrawn

Other trials in Argentina

Canada7 sites, 7 recruiting

Research Site
Greenfield Park, Quebec, J4V 2G9
Not yet recruiting
Research Site
Montreal, Quebec, H2X 0A9
Not yet recruiting
Research Site
Montreal, Quebec, H3T 1E2
Not yet recruiting
Research Site
Montreal, Quebec, H4A 3J1
Not yet recruiting
Research Site
Saskatoon, Saskatchewan, S7N 4H4
Not yet recruiting
Research Site
Toronto, Ontario, M5G 2M9
Not yet recruiting
Research Site
Toronto, M4N 3M5
Not yet recruiting

Other trials in Canada

Hungary7 sites, 6 recruiting

Research Site
Budapest, 1062
Not yet recruiting
Research Site
Budapest, 1082
Recruiting
Research Site
Budapest, 1122
Recruiting
Research Site
Budapest, 1145
Recruiting
Research Site
Debrecen, 4032
Recruiting
Research Site
Miskolc, 3526
Recruiting
Research Site
Zalaegerszeg, 8900
Withdrawn

Other trials in Hungary

Taiwan7 sites, 7 recruiting

Research Site
New Taipei City, 23561
Recruiting
Research Site
Taichung
Recruiting
Research Site
Tainan, 704
Recruiting
Research Site
Taipei, 100
Recruiting
Research Site
Taipei, 10449
Recruiting
Research Site
Taipei, 112
Recruiting
Research Site
Taoyuan, 00333
Recruiting

Other trials in Taiwan

Czechia6 sites, 6 recruiting

Research Site
Brno, 656 53
Recruiting
Research Site
Hořovice, 26831
Recruiting
Research Site
Hradec Králové, 500 05
Recruiting
Research Site
Olomouc, 77900
Recruiting
Research Site
Prague, 120 00
Recruiting
Research Site
Prague, 180 00
Not yet recruiting

Other trials in Czechia

Portugal6 sites, 6 recruiting

Research Site
Coimbra, 3000-075
Recruiting
Research Site
Lisbon, 1099-023
Recruiting
Research Site
Lisbon, 1998-018
Recruiting
Research Site
Matosinhos Municipality, 4454-509
Recruiting
Research Site
Porto, 4050-115
Recruiting
Research Site
Vila Real, 5000-508
Recruiting

Other trials in Portugal

Thailand6 sites, 5 recruiting

Research Site
Bangkok, 10210
Recruiting
Research Site
Bangkok, 10330
Recruiting
Research Site
Dusit, 10300
Terminated
Research Site
Hat Yai, 90110
Recruiting
Research Site
Muang, 22000
Recruiting
Research Site
Ratchathewi, 10400
Recruiting

Other trials in Thailand

Turkey (Türkiye)6 sites, 5 recruiting

Research Site
Adapazarı, 54290
Recruiting
Research Site
Altındağ-Ankara, 06230
Recruiting
Research Site
Ankara, 06530
Recruiting
Research Site
Çankaya, 06680
Withdrawn
Research Site
Istanbul, 34214
Recruiting
Research Site
Kayseri, 38039
Recruiting

Other trials in Turkey (Türkiye)

Chile5 sites, 5 recruiting

Research Site
Providencia, 7500994
Recruiting
Research Site
Recoleta, 8420391
Recruiting
Research Site
Santiago, 8330034
Recruiting
Research Site
Talca, 3461341
Recruiting
Research Site
Viña del Mar, 2520000
Recruiting

Other trials in Chile

Israel5 sites, 5 recruiting

Research Site
Jerusalem, 9103102
Recruiting
Research Site
Jerusalem, 9112001
Recruiting
Research Site
Petah Tikva, 49100
Recruiting
Research Site
Ramat Gan, 52621
Recruiting
Research Site
Tel Aviv, 64239
Recruiting

Other trials in Israel

Malaysia5 sites, 5 recruiting

Research Site
Bandar Puncak Alam, 42300
Not yet recruiting
Research Site
Johor Bahru, 81100
Recruiting
Research Site
Kuala Lumpur, 59100
Recruiting
Research Site
Kuala Selangor, 62250
Recruiting
Research Site
Malacca, 75000
Recruiting

Other trials in Malaysia

Australia4 sites, 3 recruiting

Research Site
Darlinghurst, 2010
Recruiting
Research Site
Darlinghurst, 2139
Recruiting
Research Site
Malvern, 3144
Withdrawn
Research Site
Melbourne, VIC 3000
Recruiting

Other trials in Australia

Austria4 sites, 4 recruiting

Research Site
Graz, 8036
Recruiting
Research Site
Innsbruck, 6020
Recruiting
Research Site
Linz, 4010
Recruiting
Research Site
Vienna, 1090
Recruiting

Other trials in Austria

Bulgaria4 sites, 3 recruiting

Research Site
Plovdiv, 4002
Recruiting
Research Site
Sofia, 1527
Recruiting
Research Site
Stara Zagora, 6003
Recruiting
Research Site
Vratsa, 3000
Withdrawn

Other trials in Bulgaria

Peru4 sites, 4 recruiting

Research Site
Bellavista, CALLAO 2
Not yet recruiting
Research Site
Jesus Maria, Lima, LIMA 11
Not yet recruiting
Research Site
Lima, 15036
Not yet recruiting
Research Site
Lima, LIMA 29
Not yet recruiting

Other trials in Peru

Hong Kong2 sites, 2 recruiting

Research Site
Hong Kong, 150001
Not yet recruiting
Research Site
Hong Kong, 999077
Recruiting

Other trials in Hong Kong

Puerto Rico1 site, 1 recruiting

Research Site
San Juan, 00918
Recruiting

Other trials in Puerto Rico

About this study

Official title: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

Read the detailed description

Approximately 4680 participants will be screened to achieve approximately 788 participants randomised to study intervention.

Participants will be randomised in a 2:2:1:2 ratio to one of the following intervention groups:

Arm 1: saruparib (AZD5305) plus camizestrant
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
Arm 3: Physician's choice CDK4/6i plus camizestrant
Arm 4: Saruparib (AZD5305) plus physician's choice ET

Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.

Conditions: Advanced Breast Cancer
Being tested: Saruparib (AZD5305), Camizestrant, Abemaciclib, Ribociclib, Palbociclib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Saruparib (AZD5305)Drug
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.
CamizestrantDrug
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .
AbemaciclibDrug
CDK4/6 Inhibitor
RibociclibDrug
CDK4/6 Inhibitor
PalbociclibDrug
CDK 4/6 Inhibitor
FulvestrantDrug
Endocrine Therapy
LetrozoleDrug
Endorcine Therapy
AnastrozoleDrug
Endocrine Therapy
ExemestaneDrug
Endocrine Therapy

Study groups in NCT06380751
Study group	Role	What they receive
Arm 1: saruparib (AZD5305) plus camizestrant	Experimental	participants will receive saruparib (AZD5305) orally and camizestrant orally Receives: Drug: Saruparib (AZD5305); Drug: Camizestrant
Arm 2: Physician's choice CDK4/6i plus physician's choice ET	Active comparator	agents are indicated below and should follow local guidelines: * Physician's Choice CDK4/6i: * abemaciclib orally, or * ribociclib orally, or * palbociclib orally. * Physician's Choice ET: * fulvestrant intramuscularly, or * One of the following AIs: * letrozole orally, or * anastrozole orally, or * exemestane orally Receives: Drug: Abemaciclib; Drug: Ribociclib; Drug: Palbociclib; Drug: Fulvestrant; Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane
Arm 3: Physician's choice CDK4/6i plus camizestrant	Experimental	participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines Receives: Drug: Camizestrant; Drug: Abemaciclib; Drug: Ribociclib; Drug: Palbociclib
Arm 4: Saruparib (AZD5305) plus physician's choice ET	Experimental	participants will receive Saruparib (AZD5305) plus -Physician's Choice ET: * fulvestrant intramuscularly, or * One of the following AIs: * letrozole orally, or * anastrozole orally, or * exemestane orally Receives: Drug: Saruparib (AZD5305); Drug: Fulvestrant; Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (Arm 1 vs arm 2)
PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
Measured: Up to approximately 64 months

Secondary outcomes (12)

Progression-Free Survival (arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
Measured: Up to approximately 64 months
Overall Survival (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
OS is defined as the time from randomisation until the date of death due to any cause.
Measured: Up to approximately 88 months
Progression Free Survival 2 (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
PFS2 is defined as the time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.
Measured: Up to approximately 64 months
Time to chemotherapy (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time to chemotherapy is defined as time from randomisation until the start date of the first subsequent chemotherapy treatment after discontinuation of randomised treatment (censoring participants who died prior to initiation of chemotherapy).
Measured: Up to approximately 64 months
Objective Response Rate (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
ORR is defined as the proportion of participants who have a complete or partial response, as determined by BICR per RECIST v1.1.
Measured: Up to approximately 64 months
Duration of Response (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
Measured: Up to approximately 64 months
Participant-reported tolerability (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Proportion of all dosed participants reporting different levels of severity of diarrhoea as measured by the diarrhoea single item (EORTC IL237/IL239/IL240) and different levels of severity of abdominal pain as measured by the abdominal pain single item (EORTC IL237/IL239/IL240).
Measured: Up to approximately 64 months
Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the EORTC quality of life questionnaire (QLQ) (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
This scale includes 2 items asking participants to report overall health and overall quality of life in the past week. Both items are measured on a 6-point verbal rating scale ranging from Very Poor to Excellent. Single item scores are averaged to calculate a subscale score that is transformed to range from 0 to 100, where higher scores indicate better global health status/QoL.
Measured: Up to approximately 64 months
Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the EORTC quality of life questionnaire (QLQ) (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
This scale includes 2 items asking participants to report overall health and overall quality of life in the past week. Both items are measured on a 6-point verbal rating scale ranging from Very Poor to Excellent. Single item scores are averaged to calculate a subscale score that is transformed to range from 0 to 100, where higher scores indicate better global health status/QoL.
Measured: Up to approximately 64 months
Plasma concentrations of saruparib (AZD5305)
Measured: Up to approximately 64 months
Plasma concentrations of camizestrant
Measured: Up to approximately 64 months
Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
Samples will be tested by a CDx to confirm BRCA1/2 and PALB2 gene mutation status
Measured: Up to approximately 64 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202430 Dec 2031

First posted24 Apr 2024
Study start1 Aug 2024
Primary completion18 Dec 2029 (estimated)
Study completion30 Dec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 788 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06380751
Sponsor's protocol ID: D9722C00001
Acronym: EvoPAR-BR01
Status last verified: Oct 2026
First submitted: 25 Mar 2024
Last updated: 30 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Advanced Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)
ClinicalTrials.gov ID: NCT06380751
Acronym / sponsor ID: EvoPAR-BR01 / D9722C00001
Conditions: Advanced Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 788 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 1 Aug 2024 (actual)
Primary completion: 18 Dec 2029 (estimated)
Study completion: 30 Dec 2031 (estimated)
First posted: 24 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 4680 participants will be screened to achieve approximately 788 participants randomised to study intervention.

Participants will be randomised in a 2:2:1:2 ratio to one of the following intervention groups:

Arm 1: saruparib (AZD5305) plus camizestrant
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
Arm 3: Physician's choice CDK4/6i plus camizestrant
Arm 4: Saruparib (AZD5305) plus physician's choice ET

Treatment continues until BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant withdraws consent.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm 1: saruparib (AZD5305) plus camizestrant	Experimental	Drug: Saruparib (AZD5305), Drug: Camizestrantparticipants will receive saruparib (AZD5305) orally and camizestrant orally
Arm 2: Physician's choice CDK4/6i plus physician's choice ET	Active comparator	Drug: Abemaciclib, Drug: Ribociclib, Drug: Palbociclib, Drug: Fulvestrant, Drug: Letrozole, Drug: Anastrozole, Drug: Exemestaneagents are indicated below and should follow local guidelines: * Physician's Choice CDK4/6i: * abemaciclib orally, or * ribociclib orally, or * palbociclib orally. * Physician's Choice ET: * fulvestrant intramuscularly, or * One of the following AIs: * letrozole orally, or * anastrozole orally, or * exemestane orally
Arm 3: Physician's choice CDK4/6i plus camizestrant	Experimental	Drug: Camizestrant, Drug: Abemaciclib, Drug: Ribociclib, Drug: Palbociclibparticipants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines
Arm 4: Saruparib (AZD5305) plus physician's choice ET	Experimental	Drug: Saruparib (AZD5305), Drug: Fulvestrant, Drug: Letrozole, Drug: Anastrozole, Drug: Exemestaneparticipants will receive Saruparib (AZD5305) plus -Physician's Choice ET: * fulvestrant intramuscularly, or * One of the following AIs: * letrozole orally, or * anastrozole orally, or * exemestane orally

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease
ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
FFPE tumour tissue from each participant

Key exclusion criteria (29 listed)

Participants with history of MDS/AML or with features suggestive of MDS/AML
Participants with any known predisposition to bleeding
Any history of persisting severe cytopenia
Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Saruparib (AZD5305)Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.	Drug	Arm 1: saruparib (AZD5305) plus camizestrant, Arm 4: Saruparib (AZD5305) plus physician's choice ET
CamizestrantCamizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .	Drug	Arm 1: saruparib (AZD5305) plus camizestrant, Arm 3: Physician's choice CDK4/6i plus camizestrant
AbemaciclibCDK4/6 Inhibitor	Drug	Arm 2: Physician's choice CDK4/6i plus physician's choice ET, Arm 3: Physician's choice CDK4/6i plus camizestrant
RibociclibCDK4/6 Inhibitor	Drug	Arm 2: Physician's choice CDK4/6i plus physician's choice ET, Arm 3: Physician's choice CDK4/6i plus camizestrant
PalbociclibCDK 4/6 Inhibitor	Drug	Arm 2: Physician's choice CDK4/6i plus physician's choice ET, Arm 3: Physician's choice CDK4/6i plus camizestrant
FulvestrantEndocrine Therapy	Drug	Arm 2: Physician's choice CDK4/6i plus physician's choice ET, Arm 4: Saruparib (AZD5305) plus physician's choice ET
LetrozoleEndorcine Therapy	Drug	Arm 2: Physician's choice CDK4/6i plus physician's choice ET, Arm 4: Saruparib (AZD5305) plus physician's choice ET
AnastrozoleEndocrine Therapy	Drug	Arm 2: Physician's choice CDK4/6i plus physician's choice ET, Arm 4: Saruparib (AZD5305) plus physician's choice ET
ExemestaneEndocrine Therapy	Drug	Arm 2: Physician's choice CDK4/6i plus physician's choice ET, Arm 4: Saruparib (AZD5305) plus physician's choice ET

Primary outcome

Progression-Free Survival (Arm 1 vs arm 2)
Time frame: Up to approximately 64 months
PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.

12 secondary outcomes

Progression-Free Survival (arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time frame: Up to approximately 64 months
Overall Survival (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time frame: Up to approximately 88 months
Progression Free Survival 2 (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time frame: Up to approximately 64 months
Time to chemotherapy (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time frame: Up to approximately 64 months
Objective Response Rate (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time frame: Up to approximately 64 months
Duration of Response (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time frame: Up to approximately 64 months
Participant-reported tolerability (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time frame: Up to approximately 64 months
Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the EORTC quality of life questionnaire (QLQ) (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time frame: Up to approximately 64 months
Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the EORTC quality of life questionnaire (QLQ) (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)
Time frame: Up to approximately 64 months
Plasma concentrations of saruparib (AZD5305)
Time frame: Up to approximately 64 months
Plasma concentrations of camizestrant
Time frame: Up to approximately 64 months
Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
Time frame: Up to approximately 64 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Related trials for Advanced Breast Cancer

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
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RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

306 sites in 29 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saruparib (AZD5305), Camizestrant and Abemaciclib in people with Advanced Breast Cancer, run by AstraZeneca at 306 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 306 sites in United States, China, Japan, Germany, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (Arm 1 vs arm 2) (time frame: Up to approximately 64 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06380751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.