Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC
NCT ID: NCT03997123
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
923 participants
INTERVENTIONAL
2019-06-25
2026-03-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Capivasertib + Paclitaxel
Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.
Capivasertib: Oral tablets. 400 mg of Capivasertib (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.
Capivasertib
400 mg (2 oral tablets) given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Study treatment will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.
Paclitaxel
80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.
Placebo + Paclitaxel
Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.
Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.
Paclitaxel
80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.
Placebo
Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week offtreatment within each 28-day treatment cycle
Interventions
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Capivasertib
400 mg (2 oral tablets) given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Study treatment will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.
Paclitaxel
80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.
Placebo
Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week offtreatment within each 28-day treatment cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Metastatic or locally recurrent disease; locally recurrent disease most not be amenable to resection with curative intent (patient who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
3. ECOG/WHO PS: 0-1
4. Measurable disease according to RECIST 1.1 and/or lytics or mixedbone lesions that can be assessed by CT or MRI in the absence of measurable disease
5. FFPE tumour sample from primary/recurrent cancer
Exclusion Criteria
2. Prior systematic therapy for inoperable locally advanced or metastatic disease
3. Prior treatment with any of the treatments listed below. Patients are not eligible to enter the study if they have received any of the medications specified below or are unable to meet the cautions and restrictions:
* AKT, PI3K, and/or mTOR inhibitors
* Capivasertib in the present study (ie, any dosing with capivasertib due to previous participation in this study)
* Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long halflife (eg, biologics) as agreed by the sponsor
* Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to the first dose of study treatment.
4. Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo)
5. Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5
6. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
7. Any of the following cardiac criteria at screening:
* Mean resting corrected QT interval (QTc) \>470 msec obtained from 3 consecutive ECGs
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block)
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
* Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥2
* Uncontrolled hypotension - SBP \<90 mmHg and/or DBP \<50 mmHg
* Cardiac ejection fraction outside institutional range of normal or \<50% (whichever is higher) as measured by echocardiogram (or multiplegated acquisition \[MUGA\] scan if an echocardiogram cannot be performed or is inconclusive).
8. Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening:
* Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment
* HbA1c ≥8.0% (63.9 mmol/mol)
9. Inadequate bone marrow reserve or organ function at screening
10. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Schmid, MD,PhD,FRCP
Role: PRINCIPAL_INVESTIGATOR
Centre for Experimental Cancer Medicine (CECM), Barts Cancer Institute
Locations
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Whittier, California, United States
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Whittier, California, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Chicago, Illinois, United States
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Westwood, Kansas, United States
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Silver Spring, Maryland, United States
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Detroit, Michigan, United States
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Nyack, New York, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Harrisburg, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Fairfax, Virginia, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Ciudad Autonomade Buenos Aires, , Argentina
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La Plata, , Argentina
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Mar del Plata, , Argentina
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Rosario, , Argentina
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Barretos, , Brazil
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Florianópolis, , Brazil
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Goiânia, , Brazil
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Londrina, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Victoria, British Columbia, Canada
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Kitchener, Ontario, Canada
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North York, Ontario, Canada
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Toronto, Ontario, Canada
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Foshan, , China
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Guangzhou, , China
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Guiyang, , China
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Haikou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Jinan, , China
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Linyi, , China
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Nanchang, , China
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Nanjing, , China
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Nanyang, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
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Ürümqi, , China
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Wenzhou, , China
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Wuhan, , China
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Wuhan, , China
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Xi'an, , China
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Zhengzhou, , China
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Floridablanca, , Colombia
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Ibagué, , Colombia
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Medellín, , Colombia
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Montería, , Colombia
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Valledupar, , Colombia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Brest, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Saint-Herblain, , France
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Villejuif, , France
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Heraklion, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Nyíregyháza, , Hungary
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Szekszárd, , Hungary
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Bangalore, , India
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Bangalore, , India
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Gurgaon, , India
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Kolkata, , India
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Kolkata, , India
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Mumbai, , India
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Mysuru, , India
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Nagpur, , India
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Nagpur, , India
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Nashik, , India
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New Delhi, , India
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New Delhi, , India
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Bunkyō City, , Japan
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Fukuoka, , Japan
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Hidaka-shi, , Japan
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Hiroshima, , Japan
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Kagoshima, , Japan
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Kitaadachi-gun, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Ota-shi, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Sunto-gun, , Japan
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Takasaki-shi, , Japan
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Tsu, , Japan
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Tsukuba, , Japan
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Yokohama, , Japan
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Selangor, , Malaysia
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Kuching, , Malaysia
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Aguascalientes, , Mexico
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Estado de México, , Mexico
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Guadalajara, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Tuxtla Gutiérrez, , Mexico
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Tuxtla Gutiérrez, , Mexico
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Arequipa, , Peru
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Callao, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Bacolod, , Philippines
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Baguio City, , Philippines
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Cagayan de Oro, , Philippines
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Cebu City, , Philippines
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Davao City, , Philippines
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Iloilo City, , Philippines
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Iloilo City, , Philippines
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Las Piñas, , Philippines
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Legaspi, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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San Juan City, , Philippines
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Bydgoszcz, , Poland
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Konin, , Poland
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Poznan, , Poland
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Racibórz, , Poland
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Radom, , Poland
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Tomaszów Mazowiecki, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Arkhangelsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Volgograd, , Russia
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Yaroslavl, , Russia
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Dammam, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Mecca, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Bratislava, , Slovakia
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Busan, , South Korea
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Cheonan-si, , South Korea
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Cheongju-si, , South Korea
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Daegu, , South Korea
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Goyang-si, , South Korea
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Incheon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Badalona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Hospitalet deLlobregat, , Spain
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Jaén, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Hsinchu, , Taiwan
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Hualien City, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Tainan, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Mueang, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Edinburgh, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Sheffield, , United Kingdom
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Surrey, , United Kingdom
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York, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2018-004687-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3614C00001
Identifier Type: -
Identifier Source: org_study_id