一项旨在了解 Camizestrant 与 Palbociclib 一起在患有一种具有 ER 蛋白但没有 HER2 蛋白过度表达的晚期乳腺癌的参与者中发挥作用的试验。 (SERENA-4)
SERENA-4：一项关于 AZD9833（一种口服 SERD）加 Palbociclib 与阿那曲唑加 Palbociclib 的随机、多中心、双盲、III 期研究，用于治疗未接受过 HER2 阴性、雌激素受体阳性的晚期乳腺癌患者晚期疾病的任何全身治疗
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer.
INFORMATION FOR TRIAL PARTICIPANTS
In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment.
Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.
研究概览
地位
详细说明
A Randomised, Multicentre, Double-Blind, Phase III study will evaluate the safety and efficacy of AZD9833 (next generation oral SERD) in combination with palbociclib versus anastrozole in combination with palbociclib for the treatment of patients with ER-positive breast cancer. The goal of the study is to demonstrate superiority of AZD9833 over anastrozole in the context of combination with palbociclib in first line setting.
INFORMATION FOR TRIAL PARTICIPANTS
Researchers are looking for a better way to treat breast cancer.
In people with cancer, some cells have grown out of control to form tumours.
The trial drugs palbociclib, camizestrant, and anastrozole are designed to work by blocking the cancer's ability to grow. Camizestrant is also called AZD9833. Palbociclib and anastrozole are already available as treatments for people with certain type of breast cancer.
In this trial, the researchers want to find out how well taking camizestrant with palbociclib, or anastrozole with palbociclib, works in participants with breast cancer that has ER proteins but does not have overexpression of HER2 protein.
The researchers will look at which trial treatments help the participants live longer with cancer before it gets worse.
The trial will split participants into 2 groups:
- Participants in Group 1 will take camizestrant, palbociclib, and a placebo matched with anastrazole.
- Participants in Group 2 will take anastrozole, palbociclib, , and a placebo matched with camizestrant.
A placebo looks like a treatment but does not have any medicine in it.
A computer program will be used to randomly choose the treatments each participant gets. This helps make sure the groups are chosen fairly. Researchers do this so that comparing the results of each treatment will be as accurate as possible.
The participants will take their trial treatments in periods called "cycles". Each cycle will last 28 days. During each cycle, the participants will take:
- camizestrant or anastrozole once daily by mouth
- palbociclib once daily by mouth for 21 days. Then, they will not take any palbociclib for 7 days
Some participants will also get either goserelin or leuprorelin once every month. Participants could get goserelin or leuprorelin if:
- They are medically determined yet to reach menopause status
- They are male
They will get this treatment as an injection under the skin or into a muscle. Goserelin and leuprorelin work by decreasing the amount of sex hormones made by the body which will lead to reduction of ER production. This can help stop breast cancer from growing.
Participants will take trial treatment until the cancer gets worse or they leave the trial.
Participants will visit their trial site several times throughout the trial. At these visits, the trial doctors will check the health of the participants. They will also take blood samples and do scans of the participants' tumors.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Baoding、中国、071000
- Research Site
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Beijing、中国、100142
- Research Site
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Beijing、中国
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Beijing、中国、100039
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Bengbu、中国、233004
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Changchun、中国、130021
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Changchun、中国、130000
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Changsha、中国、410013
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Chengdu、中国、610042
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Chongqing、中国、400042
- Research Site
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Dalian、中国、116011
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Guangzhou、中国、510060
- Research Site
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Guangzhou、中国、510100
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Guiyang、中国、550004
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Haikou、中国、570311
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Hangzhou、中国、310022
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Hangzhou、中国、310020
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Hefei、中国、230031
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Jinan、中国、250117
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Lanzhou、中国、730000
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Linyi、中国、276000
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Nanchang、中国、330009
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Nanjing、中国、210008
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Shanghai、中国、200032
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Shanghai、中国、200025
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Shenyang、中国、110001
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Tianjin、中国、300060
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Wuhan、中国、430000
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Wuhan、中国、430040
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Xi'an、中国、710061
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Zhengzhou、中国、450008
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Kaluga、俄罗斯、248007
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Kislino Village, Ryshkovsky Ru、俄罗斯、305524
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Moscow、俄罗斯、115478
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Moscow、俄罗斯、117997
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Moscow、俄罗斯、121467
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Moscow、俄罗斯、111123
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Saint Petersburg、俄罗斯、190103
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Saint Petersburg、俄罗斯、197758
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Saint Petersburg、俄罗斯、195067
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Saint Petersburg、俄罗斯、196603
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Plovdiv、保加利亚、4000
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Plovdiv、保加利亚、4109
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Shumen、保加利亚、9700
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Sofia、保加利亚、1431
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Sofia、保加利亚、1527
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Sofia、保加利亚、1330
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Montreal、加拿大、H3T 1E2
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Alberta
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Edmonton、Alberta、加拿大、T6G 1Z2
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British Columbia
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Vancouver、British Columbia、加拿大、V5Z 1H7
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Ontario
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Kitchener、Ontario、加拿大、N2G 1G3
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London、Ontario、加拿大、N6A 5W9
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Toronto、Ontario、加拿大、M5G 2M9
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Budapest、匈牙利、1122
- Research Site
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Budapest、匈牙利、1062
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Budapest、匈牙利、1088
- Research Site
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Győr、匈牙利、9024
- Research Site
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Miskolc、匈牙利、3526
- Research Site
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Nyíregyháza、匈牙利、4400
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Szekszárd、匈牙利、7100
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Zalaegerszeg、匈牙利、8900
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Ahmedabad、印度、380060
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Calicut、印度、673601
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Delhi、印度、110085
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Faridabad、印度、121001
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Gūrgaon、印度、122001
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Karamsad、印度、388325
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Kolkata、印度、700160
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Madurai、印度、625107
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Nagpur、印度、440001
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Nashik、印度、422009
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Nashik、印度、422011
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New Delhi、印度、110029
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Kaohsiung City、台湾、82445
- Research Site
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Kaohsiung City、台湾
- Research Site
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Taichung、台湾、40443
- Research Site
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Tainan、台湾、70403
- Research Site
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Taipei、台湾、235
- Research Site
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Taipei、台湾、10048
- Research Site
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Taipei、台湾、104
- Research Site
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Taipei、台湾、110
- Research Site
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Taoyuan、台湾、333
- Research Site
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Adana、土耳其（türkiye）、01120
- Research Site
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Ankara、土耳其（türkiye）、06230
- Research Site
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Ankara、土耳其（türkiye）、06010
- Research Site
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Ankara、土耳其（türkiye）、06340
- Research Site
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Ankara、土耳其（türkiye）、6100
- Research Site
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Izmir、土耳其（türkiye）、35100
- Research Site
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Izmir、土耳其（türkiye）、35620
- Research Site
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Kayseri、土耳其（türkiye）、38039
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Del. Cuauhtemoc、墨西哥、06700
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La Paz、墨西哥、23040
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Mexico City、墨西哥、0 3100
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Monterrey、墨西哥、64710
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Puebla City、墨西哥、72424
- Research Site
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Toluca、墨西哥、50120
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Feldkirch、奥地利、6807
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Salzburg、奥地利、5020
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Vienna、奥地利、1130
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Berlin、德国、13125
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Dessau-RoBlau、德国、06847
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Essen、德国、45136
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Freiburg im Breisgau、德国、79110
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Mönchengladbach、德国、41061
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München、德国、81675
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Münster、德国、48145
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Regensburg、德国、93053
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Velbert、德国、42551
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Bergamo、意大利、24127
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Florence、意大利、50139
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Milan、意大利、20141
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Modena、意大利、41124
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Naples、意大利、80131
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Novara、意大利、28100
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Padova、意大利、35128
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Parma、意大利、43100
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Prato、意大利、59100
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Roma、意大利、00168
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Roma、意大利、161
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Rozzano、意大利、20089
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Drammen、挪威、3004
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Oslo、挪威、N-0379
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Hořovice、捷克语、268 01
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Hradec Králové、捷克语、500 05
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Nový Jičín、捷克语、741 01
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Prague、捷克语、100 34
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Prague、捷克语、150 06
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Prague、捷克语、140 00
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Banská Bystrica、斯洛伐克、974 01
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Bratislava、斯洛伐克、833 01
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Bratislava、斯洛伐克、81250
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Prešov、斯洛伐克、081 81
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Trenčín、斯洛伐克、91171
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Chiba、日本、260-8717
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Chūōku、日本、104-0045
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Chūōku、日本、862-8655
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Hidaka-shi、日本、350-1298
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Hirakata-shi、日本、573-1191
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Isehara-shi、日本、259-1193
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Kitaadachi-gun、日本、362-0806
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Kumamoto、日本、860-8556
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Kurashiki Shi、日本、701 0192
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Kurume-shi、日本、830-0013
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Kyoto、日本、606-8507
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Kōtoku、日本、135-8550
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Nagoya、日本、464-8681
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Nagoya、日本、467-8602
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Nishinomiya-shi、日本、663-8501
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Osaka、日本、540-0006
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Osaka、日本、541-8567
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Ota-shi、日本、373-8550
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Sapporo、日本、003-0804
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Sendai、日本、980-8574
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Shimotsuke-shi、日本、329-0498
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Shinagawa-ku、日本、142-8666
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Shinjuku-ku、日本、162-8655
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Suita-shi、日本、565-0871
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Takasaki-shi、日本、370-0829
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Tsu、日本、514-8507
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Tsukuba、日本、305-8576
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Yokohama、日本、241-8515
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Concepción、智利、4070196
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La Serena、智利、1720430
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Santiago、智利、7630370
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Santiago、智利、8241479
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Anderlecht、比利时、1070
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Edegem、比利时、2650
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Ghent、比利时、9000
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Leuven、比利时、3000
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Liège、比利时、4000
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Namur、比利时、5000
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Sint-Niklaas、比利时、9100
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Besançon、法国、25030
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Bordeaux、法国、33030
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Brest、法国、29609
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Caen、法国、14076
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Dijon、法国、21079
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Le Mans、法国、72000
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Lille、法国、59000
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Montpellier、法国、34070
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Pierre-Bénite、法国、69495
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Plerin SUR MER、法国、22190
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Saint-Cloud、法国、92210
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Vandœuvre-lès-Nancy、法国、54000
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Villejuif、法国、94805
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Gdynia、波兰、81-519
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Konin、波兰、62-500
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Koszalin、波兰、75-581
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Lodz、波兰、90-302
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Lublin、波兰、20-090
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Olsztyn、波兰、10-513
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Poznan、波兰、60-192
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Liestal、瑞士、CH- 4410
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Zurich、瑞士、8008
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Alabama
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Mobile、Alabama、美国、36604
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Arkansas
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Springdale、Arkansas、美国、72762
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California
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Harbor City、California、美国、90710
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Solvang、California、美国、93463
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Colorado
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Lone Tree、Colorado、美国、80124
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Florida
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Fort Myers、Florida、美国、33901-8101
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Jacksonville、Florida、美国、32256
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West Palm Beach、Florida、美国、33401
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Indiana
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Indianapolis、Indiana、美国、46256
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Louisiana
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Baton Rouge、Louisiana、美国、70809
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Maryland
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Silver Spring、Maryland、美国、20904
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Massachusetts
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Boston、Massachusetts、美国、02114
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Michigan
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Detroit、Michigan、美国、48202
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Mississippi
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Hattiesburg、Mississippi、美国、39401
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Nebraska
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Omaha、Nebraska、美国、68130
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Ohio
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Cincinnati、Ohio、美国、45219
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Cincinnati、Ohio、美国、45267
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Oregon
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Portland、Oregon、美国、97239
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South Carolina
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West Columbia、South Carolina、美国、29169
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South Dakota
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Sioux Falls、South Dakota、美国、57105
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Tennessee
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Chattanooga、Tennessee、美国、37404
- Research Site
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Nashville、Tennessee、美国、37203
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Texas
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Austin、Texas、美国、78731
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Houston、Texas、美国、77030
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Houston、Texas、美国、77090
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Tyler、Texas、美国、75702
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Virginia
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Fairfax、Virginia、美国、22031
- Research Site
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Washington
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Kennewick、Washington、美国、99336
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Renton、Washington、美国、98055
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West Virginia
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Morgantown、West Virginia、美国、26505
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Cambridge、英国、CB2 2QQ
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Colchester、英国、CO4 5JL
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Leeds、英国、LS9 7TF
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Nottingham、英国、NG5 1PB
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Surrey、英国、GU2 7XX
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Braga、葡萄牙、4710
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Guimarães、葡萄牙、4835-044
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Lisbon、葡萄牙、1998-018
- Research Site
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Lisbon、葡萄牙、1400-038
- Research Site
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Lisbon、葡萄牙、1500-650
- Research Site
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Loures、葡萄牙、2674-514
- Research Site
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Porto、葡萄牙、4099-001
- Research Site
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Porto、葡萄牙、4200-319
- Research Site
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Vila Nova de Gaia、葡萄牙、4434-502
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Barcelona、西班牙、8035
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Barcelona、西班牙、08908
- Research Site
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Jaén、西班牙、23007
- Research Site
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Lleida、西班牙、25198
- Research Site
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Madrid、西班牙、28046
- Research Site
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Madrid、西班牙、28040
- Research Site
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Málaga、西班牙、29010
- Research Site
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Pamplona、西班牙、31005
- Research Site
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Santander、西班牙、39008
- Research Site
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Seville、西班牙、41013
- Research Site
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Valencia、西班牙、46015
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Busan、韩国、49201
- Research Site
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Daegu、韩国、41404
- Research Site
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Goyang-si、韩国、10408
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Seoul、韩国、03080
- Research Site
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Seoul、韩国、03722
- Research Site
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Seoul、韩国、05505
- Research Site
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Seoul、韩国、06273
- Research Site
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Seoul、韩国、06351
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George Town、马来西亚、10450
- Research Site
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Johor Bahru、马来西亚、81100
- Research Site
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Kuala Lumpur、马来西亚、59100
- Research Site
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Kuala Lumpur、马来西亚、50586
- Research Site
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Kuala Selangor、马来西亚、62250
- Research Site
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Kuching、马来西亚、93586
- Research Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
INCLUSION CRITERIA
Full list of inclusion criteria
- Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment.
- De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.
- Histologically or cytologically documented diagnosis of ER+, HER2-negative breast cancer based on local laboratory results.
- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
- Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ and marrow function.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
INFORMATION FOR TRIAL PARTICIPANTS
Participants can join the trial if they:
- Have breast cancer that cannot be treated with surgery or radiation
- Have breast cancer that has already spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of a standard endocrine treatment
- Have ER proteins but not overexpression of HER2 protein in their tumors
- Have never received any type of cancer therapy that affects the whole body for advanced breast cancer
- Are able to do their daily activities
EXCLUSION CRITERIA
Full list of exclusion criteria
- Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment.
- Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant.
- Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term and/or impending visceral crisis
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
- Any clinically important and symptomatic heart disease .
- Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding diseases) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- Any concurrent anti-cancer treatment.
- Active infection including tuberculosis, HBV and HCV.
INFORMATION FOR TRIAL PARTICIPANTS
Participants cannot join the trial if they:
- Have uncontrolled cancer that has spread to the brain or the spinal cord
- Have received certain treatments for cancer in the past but the cancer came back within 1 year
- Had certain types of tumors in the past, which the study doctors think could come back
- Are currently taking any treatment for cancer or are taking medications or supplements that affect certain proteins in the body
- Have any major health problem, infection, or surgery that could make it difficult or dangerous to participate in this trial, such as tuberculosis, HIV, heart problems, or a kidney transplant
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：AZD9833 + palbociclib
The patients will receive AZD9833 (75 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + anastrozole placebo (1 mg, PO, once daily) |
Dosage formulation: AZD9833 tablets will be administered orally Dosage formulation: anastrozole placebo tablets will be administrated orally. Dosage formulation: palbociclib tablets/capsules will be administered orally Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist. |
|
有源比较器：Anastrozole + palbociclib
The patients will recieve Anastrozole (1 mg, PO, once daily) + palbociclib (PO, once daily, 125 mg for 21 consecutive days followed by 7 days off treatment) + AZD9833 placebo (PO, once daily) |
Dosage formulation: palbociclib tablets/capsules will be administered orally Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist. Dosage formulation: Anastrozole tablets will be administered orally. Dosage formulation: AZD9833 placebo tablets will be administrated orally. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1
大体时间：From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)
|
PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST) or death. |
From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival (OS)
大体时间：From randomization until the date of death due to any cause (up to 8 years)
|
The OS is defined as the time from randomization to death due to any cause. |
From randomization until the date of death due to any cause (up to 8 years)
|
|
Second progression-free survival (PFS2)
大体时间：From randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (up to 5 years)
|
Time to second progression or death (PFS2) will be defined as the time from randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death. |
From randomization to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death (up to 5 years)
|
|
Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1
大体时间：From randomization until a response or in the absence of a response from randomization up until progression, or the last evaluable assessment in the absence of progression (up to 5 years)
|
ORR is defined as the proportion of patients who have a CR or partial response, as determined by the investigator at local site per RECIST 1.1. |
From randomization until a response or in the absence of a response from randomization up until progression, or the last evaluable assessment in the absence of progression (up to 5 years)
|
|
Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1
大体时间：From the date of first documented response until date of documented progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)
|
The DoR will be defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. |
From the date of first documented response until date of documented progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years)
|
|
Time to chemotherapy (TTC)
大体时间：From randomization until the earlier of the start date of chemotherapy or death due to any cause (up to 5 years)
|
Time to chemotherapy is defined as the time from randomization until the earlier of the start date of chemotherapy or death due to any cause. |
From randomization until the earlier of the start date of chemotherapy or death due to any cause (up to 5 years)
|
|
Time to first subsequent anti-cancer therapy (TFST)
大体时间：From randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause (up to 5 years)
|
TFST is defined as time from randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause. |
From randomization until the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause (up to 5 years)
|
|
Clinical benefit rate at 24 weeks (CBR24)
大体时间：At least 23 weeks after randomisation
|
CBR at 24 weeks is defined as the percentage of participants who have a complete response (CR) or partial response or who have stable disease (SD) per RECIST 1.1 as assessed by the investigator at local site for at least 23 weeks after randomization (to allow for an early assessment within the assessment window). |
At least 23 weeks after randomisation
|
|
Time to second subsequent therapy (TSST)
大体时间：From randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (up to 5 years)
|
TSST is defined as time from randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause. |
From randomization until the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment, or death due to any cause (up to 5 years)
|
|
Plasma concentration of AZD9833 at specified timepoints
大体时间：on Day 15
|
To assess the steady state PK of AZD9833 in combination with palbociclib in all participants who receive at least one dose of AZD9833 per the protocol, for whom there are at least one reportable PK concentration. |
on Day 15
|
|
Change from baseline in EORTC QLQ-C30 scale scores
大体时间：From baseline to 24 weeks post progression (up to approximately 5 years)
|
Change from baseline in EORTC QLQ-C30 scale scores for each patient at each post-baseline visit. The comparison will include all randomised patients, as randomised, with baseline and at least one post-baseline visit score for the scale score. |
From baseline to 24 weeks post progression (up to approximately 5 years)
|
|
Change from baseline in EORTC QLQ-BR45 scale scores
大体时间：From baseline to 24 weeks post progression (up to approximately 5 years)
|
Change from baseline in EORTC QLQ-BR45 scale scores for each patient at each post-baseline visit. The comparison will include all randomised patients, as randomised, with baseline and at least one post-baseline visit score for the scale score. |
From baseline to 24 weeks post progression (up to approximately 5 years)
|
合作者和调查者
赞助
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- D8532C00001
- 2020-002276-12 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 共享时间框架
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共享访问标准
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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