Breast Cancer Clinical Trial

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

Summary

Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.

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Full Description

Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following recurrence or progression on or after aromatase inhibitor (AI) therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study
Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic), as per the American Society of Clinical Oncology and College of American Pathologists guideline recommendations. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.
Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression during or after most recent therapy); locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
ECOG/WHO PS: 0-1

Patients are to have received treatment with an AI (aromatase inhibitor) containing regimen (single agent or in combination) and have:

Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an AI, OR
Radiological evidence of progression while on prior AI administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy)
Patients must have measurable disease according to RECIST 1.1 and/or at least 1 lytic or mixed (lytic + sclerotic) bone lesion that can be assessed by CT or MRI; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible
FFPE tumour sample from primary/recurrent cancer for central testing

Exclusion Criteria:

Symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgement
More than 2 lines of endocrine therapy for inoperable locally advanced or metastatic disease
More than 1 line of chemotherapy for inoperable locally advanced or metastatic disease. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for advanced breast cancer

Prior treatment with any of the following:

AKT, PI3K and mTOR inhibitors
Fulvestrant, and other SERDs
Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation.
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 study treatment initiation.
Radiotherapy with a wide field of radiation up to 4 weeks before study treatment initiation (capivasertib/placebo) and/or radiotherapy with a limited field of radiation for palliation up to 2 weeks before study treatment initiation (capivasertib/placebo)
With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids up to 4 weeks before study treatment initiation

Any of the following cardiac criteria:

Mean resting QT interval corrected by Fridericia's formula (QTcF) >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 corrected QT interval (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 - systolic blood pressure <90 mmHg andor diastolic blood pressure <50 mmHg
Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive)

Clinically significant abnormalities of glucose metabolism as defined by any of the following:

Patients with diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin treatment
HbA1c ≥8.0% (63.9 mmol/mol)
Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or LHRH agonist (if applicable)
Currently pregnant (confirmed with positive pregnancy test) or breast-feeding

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

834

Study ID:

NCT04305496

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 258 Locations for this study

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Gilbert Arizona, 85234, United States
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Tucson Arizona, 85715, United States
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Tucson Arizona, 85745, United States
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Orange California, 92868, United States
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Redlands California, 92373, United States
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San Francisco California, 94143, United States
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Santa Maria California, 93454, United States
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Thousand Oaks California, 91361, United States
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Whittier California, 90603, United States
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Whittier California, 90603, United States
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Fort Myers Florida, 33905, United States
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Jacksonville Florida, 32224, United States
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Orlando Florida, 32804, United States
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Marietta Georgia, 30060, United States
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Westwood Kansas, 66205, United States
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Baltimore Maryland, 21201, United States
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Boston Massachusetts, 02111, United States
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Royal Oak Michigan, 48073, United States
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Rochester Minnesota, 55905, United States
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Kansas City Missouri, 64132, United States
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Saint Louis Missouri, 63156, United States
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Henderson Nevada, 89052, United States
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Paramus New Jersey, 07652, United States
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Farmington New Mexico, 87401, United States
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Lake Success New York, 11042, United States
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New York New York, 10011, United States
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New York New York, 10065, United States
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Rochester New York, 14642, United States
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Greensboro North Carolina, 27403, United States
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Cleveland Ohio, 44106, United States
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Chattanooga Tennessee, 37404, United States
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Nashville Tennessee, 37211, United States
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Dallas Texas, 75246, United States
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Midlothian Virginia, 23114, United States
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Puyallup Washington, 98373, United States
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Berazategui , B1884, Argentina
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Ciudad Autonoma De Buenos Aire , C1125, Argentina
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La Rioja , 5300, Argentina
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Rosario , S2000, Argentina
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Viedma , R8500, Argentina
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Adelaide , 5000, Australia
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Ballarat , 3350, Australia
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Birtinya , 4575, Australia
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Box Hill , 3128, Australia
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Concord , 2139, Australia
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East Albury , 2640, Australia
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Kurralta Park , 5037, Australia
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North Sydney , 2060, Australia
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Orange , 2800, Australia
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Ringwood East , 3135, Australia
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South Brisbane , 4101, Australia
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Waratah , 2298, Australia
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Wendouree , 3355, Australia
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Brussels , 1090, Belgium
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Bruxelles , 1200, Belgium
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Charleroi , 6000, Belgium
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Edegem , 2650, Belgium
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Namur , 5000, Belgium
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Wilrijk , 2610, Belgium
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Winnipeg Manitoba, R3E 0, Canada
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Kingston Ontario, K7L 2, Canada
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Mississauga Ontario, L5M 2, Canada
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North York Ontario, M2K 1, Canada
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Toronto Ontario, M3M 0, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 1, Canada
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Montreal Quebec, H2X 3, Canada
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Montreal Quebec, H4A 3, Canada
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Saskatoon Saskatchewan, S7N 4, Canada
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Baoding , 07100, China
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Beijing , 10003, China
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Beijing , 10004, China
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Beijing , 10019, China
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Beijing , 10021, China
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Beijing , 10073, China
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Changchun , 13002, China
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Chengdu , 61004, China
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Chongqing , 40003, China
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Chongqing , 40004, China
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Dalian , 11601, China
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Foshan , 52800, China
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Gongshu District , 31002, China
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Guangzhou , 51008, China
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Guangzhou , 51009, China
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Guangzhou , 51028, China
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Hangzhou , 31000, China
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Hangzhou , 31002, China
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Harbin , 15008, China
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Hefei , 23000, China
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Hefei , 23002, China
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Jinan , 25000, China
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Jinan , 25011, China
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Linyi , 27600, China
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Nanchang , 33000, China
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Nantong , 22600, China
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Neijiang , 64100, China
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Shanghai , 20003, China
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Shanghai , 20012, China
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Shantou , CN-51, China
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Shenyang , 11000, China
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Shenyang , 11004, China
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Tianjin , 30006, China
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Wuhan , 43002, China
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Wuhan , 43003, China
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Wuhan , 43007, China
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Xi'an , 71000, China
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Xuzhou , 22100, China
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Zhengzhou City , 45000, China
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Zhengzhou , 45000, China
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Besancon , 25000, France
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Brest , 29609, France
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Metz Cedex 03 , 57085, France
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Pierre Benite CEDEX , 69310, France
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Plerin SUR MER , 22190, France
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Pringy , 74374, France
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Rouen , 76038, France
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STRASBOURG Cedex , 67065, France
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Toulouse cedex 9 , 31059, France
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Berlin , 10367, Germany
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Cottbus , 03048, Germany
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Dresden , 01307, Germany
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Erlangen , 91054, Germany
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Essen , 45130, Germany
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Frankfurt am Main , 60431, Germany
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Frankfurt , 60389, Germany
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Gelsenkirchen , 45879, Germany
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Hamburg , 20246, Germany
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Hamburg , 20249, Germany
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Hamburg , 20357, Germany
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Hannover , 30625, Germany
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Heidelberg , 69120, Germany
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Jena , 07747, Germany
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Kiel , 24105, Germany
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Mannheim , 68167, Germany
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Minden , 32429, Germany
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Muenchen , 81377, Germany
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München , 80637, Germany
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München , 81675, Germany
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Münster , 48149, Germany
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Paderborn , 33161, Germany
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Potsdam , 14467, Germany
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Budapest , 1032, Hungary
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Budapest , 1122, Hungary
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Budapest , 1134, Hungary
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Debrecen , 4032, Hungary
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Kecskemét , 6000, Hungary
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Pécs , 7624, Hungary
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Szekszárd , 7100, Hungary
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Szolnok , 5000, Hungary
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Afula , 18341, Israel
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Beer Sheva , 84101, Israel
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Haifa , 31096, Israel
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Jerusalem , 91031, Israel
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Jerusalem , 91120, Israel
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Kfar-Saba , 44281, Israel
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Petah Tikva , 49100, Israel
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Ramat Gan , 52621, Israel
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Bergamo , 24127, Italy
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Candiolo , 10060, Italy
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Catanzaro , 88100, Italy
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Genova , 16132, Italy
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Livorno , 57124, Italy
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Macerata , 62100, Italy
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Meldola , 47014, Italy
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Milano , 20141, Italy
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Modena , 41124, Italy
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Napoli , 80131, Italy
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Prato , 59100, Italy
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Reggio Nell'emilia , 42123, Italy
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Roma , 00128, Italy
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Chiba-shi , 260-8, Japan
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Chuo-ku , 104-0, Japan
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Chuo-ku , 104-8, Japan
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Fukuoka-shi , 811-1, Japan
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Fukushima-shi , 960-1, Japan
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Hidaka-shi , 350-1, Japan
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Hiroshima-shi , 730-8, Japan
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Kagoshima-shi , 892-0, Japan
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Kitaadachi-gun , 362-0, Japan
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Koto-ku , 135-8, Japan
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Kumamoto-shi , 860-8, Japan
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Kyoto-shi , 606-8, Japan
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Matsuyama-shi , 791-0, Japan
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Nagoya-shi , 464-8, Japan
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Nagoya-shi , 467-0, Japan
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Osaka-shi , 540-0, Japan
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Osaka-shi , 541-8, Japan
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Ota-shi , 373-8, Japan
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Sapporo-shi , 003-0, Japan
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Sapporo-shi , 060-8, Japan
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Shinagawa-ku , 142-8, Japan
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Tsu-shi , 514-8, Japan
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Yokohama-shi , 241-8, Japan
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Busan , 49241, Korea, Republic of
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Daegu , 41931, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Incheon , 22332, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 135-7, Korea, Republic of
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Seoul , 8308, Korea, Republic of
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Suwon-si , 16247, Korea, Republic of
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Suwon-si , 16499, Korea, Republic of
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Arequipa , AREQU, Peru
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Lima , LIMA , Peru
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Bydgoszcz , 85-79, Poland
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Krakow , 31-50, Poland
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Olsztyn , 10-22, Poland
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Warszawa , 02-78, Poland
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Kazan , 42002, Russian Federation
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Moscow , 11112, Russian Federation
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Moscow , 11547, Russian Federation
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Saint Petersburg , 19775, Russian Federation
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Saint-Petersburg , 19825, Russian Federation
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Samara , 44303, Russian Federation
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Sochi , 35400, Russian Federation
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A Coruña , 15009, Spain
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Barcelona , 08035, Spain
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Barcelona , 8003, Spain
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Barcelona , 8023, Spain
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Córdoba , 14004, Spain
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Hosp de Llobregat(Barcelona) , 08907, Spain
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Jaén , 23007, Spain
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La Laguna (Tenerife) , 38320, Spain
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Lérida , 25198, Spain
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Madrid , 28007, Spain
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Madrid , 28033, Spain
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Madrid , 28034, Spain
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Madrid , 28040, Spain
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Madrid , 28041, Spain
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Madrid , 28046, Spain
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Majadahonda , 28222, Spain
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Malaga , 29010, Spain
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Pamplona , 31008, Spain
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Reus,Tarragona , 43204, Spain
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Santiago de Compostela , 15706, Spain
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Sevilla , 41013, Spain
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Valencia , 46009, Spain
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Valencia , 46010, Spain
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Kaohsiung City , 82445, Taiwan
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Taichung , 40447, Taiwan
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Tainan City , 70403, Taiwan
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Tainan City , 710, Taiwan
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Tainan , 710, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 11217, Taiwan
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Taipei , 11259, Taiwan
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Taoyuan , 333, Taiwan
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Aberdeen , AB25 , United Kingdom
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Blackpool , FY3 8, United Kingdom
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Bournemouth , BH7 7, United Kingdom
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Bristol , BS2 8, United Kingdom
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Cardiff , CF14 , United Kingdom
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Cheltenham , GL53 , United Kingdom
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Derby , DE22 , United Kingdom
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Huddersfield , HD3 3, United Kingdom
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Lancaster , LA1 4, United Kingdom
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Leeds , BD7 1, United Kingdom
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London , N18 1, United Kingdom
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London , NW3 2, United Kingdom
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London , SE18 , United Kingdom
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London , SW3 6, United Kingdom
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Manchester , M20 4, United Kingdom
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Sutton , SM25P, United Kingdom
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York , YO31 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

834

Study ID:

NCT04305496

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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