A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer
NCT ID: NCT04588298
Last Updated: 2025-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2020-11-02
2023-06-19
Brief Summary
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Detailed Description
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Stage 1 Group 1: AZD9833 Dose A once daily Group 2: AZD9833 Dose B once daily
Stage 2 Group 1: AZD9833 Dose A once daily Group 2: AZD9833 Dose B once daily Group 3: AZD9833 Dose C once daily
Stage 3 Group 1: AZD9833 Dose A once daily Group 2: AZD9833 Dose B once daily
Adverse events and concomitant medications information will be collected throughout the study. Thereafter there will be 28-day follow-up visit after discontinuation of study treatment
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Stage 1: In this stage post-menopausal participants will be randomised in 2 cohorts in 1:1 ratio to receive AZD9833 with 12 evaluable participants in each cohort.
2. Stage 2: In this stage post-menopausal participants may be randomised in up to 3 cohorts, which may include up to 3 doses of AZD9833.
3. Stage 3 : In this stage post-menopausal participants may be randomised in up to 2 cohorts in 1:1 ratio, which may include up to 2 doses of AZD9833.
TREATMENT
NONE
Study Groups
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Stage 1: AZD9833 Dose A
Post-menopausal participants will receive once daily oral dose A of AZD9833 in stage 1 of the study.
AZD9833
AZD9833 tablets will be administered orally.
Stage 1: AZD9833 Dose B
Post-menopausal participants will receive once daily oral dose B of AZD9833 in stage 1 of the study.
AZD9833
AZD9833 tablets will be administered orally.
Stage 2: AZD9833 Dose A
Post-menopausal participants will receive once daily oral dose A of AZD9833 in stage 2 of the study.
AZD9833
AZD9833 tablets will be administered orally.
Stage 2: AZD9833 Dose B
Post-menopausal participants will receive once daily oral dose B of AZD9833 in stage 2 of the study.
AZD9833
AZD9833 tablets will be administered orally.
Stage 2: AZD9833 Dose C
Post-menopausal participants will receive once daily oral dose C of AZD9833 in stage 2 of the study.
AZD9833
AZD9833 tablets will be administered orally.
Stage 3: AZD9833 Dose A
Post-menopausal participants will receive once daily oral dose A of AZD9833 in stage 3 of the study.
AZD9833
AZD9833 tablets will be administered orally.
Stage 3: AZD9833: Dose B
Post-menopausal participants will receive once daily oral dose B of AZD9833 in stage 3 of the study.
AZD9833
AZD9833 tablets will be administered orally.
Interventions
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AZD9833
AZD9833 tablets will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* Female participants aged at least 18 years
* Post-menopausal status defined as meeting at least one of the following criteria:
1. Have undergone a bilateral oophorectomy
2. Age ≥ 60 years
3. Age ≥ 50 and \< 60 years and with cessation of menses ≥ 12 months and follicle-stimulating hormone and oestradiol levels in the post-menopausal range and with an intact uterus in the absence of oral contraception or hormone replacement therapy prior to the diagnosis of breast cancer
* Female participants with newly diagnosed primary breast cancer scheduled to undergo treatment with curative intent by surgery and irrespective of clinical node status
* Histologically confirmed invasive breast cancer involving a palpable tumour of any size, or a tumour with an ultrasound assessed diameter of ≥ 1.0 cm
* Participants with adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 3 months can be considered for the study
* According to the local laboratory participants must have:
1. ER positive breast cancer
2. HER2-negative breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Exclusion Criteria
* Intervention with any of the following:
1. Use of sex-hormone-containing drugs within 6 months prior to the first dose of study treatment
2. Medications or herbal supplements known to be strong inhibitors/inducers of CYP3A4/5, sensitive CYP2B6 substrates and drugs which are substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index
3. Drugs that are known to prolong QT and have a known risk of torsades de pointes
* Inflammatory breast cancer
* Any evidence of severe or uncontrolled systemic diseases which in the investigator's opinion makes it undesirable for the participant to participate in the study
* Any of the following cardiovascular criteria: Mean resting QTcF \> 470 msec; resting heart rate of \< 50 bpm for stages 1 and 2 at screening;resting heart rate \<60 bpm at screening for Stage 3; any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; any factors that increase the risk of QTc prolongation or risk of arrhythmic events; known left ventricular ejection fraction \< 50%; significant cardiovascular procedure or event within the last 6 months; uncontrolled hypertension or symptomatic hypotension
* Inadequate bone marrow reserve or organ function
* Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833
* History of hypersensitivity to active or inactive excipients of AZD9833
* Previous randomisation in the present study
* Judgement by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements
18 Years
130 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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John Robertson
Role: PRINCIPAL_INVESTIGATOR
Graduate Entry Medicine & Health School, University of Nottingham, Royal Derby Hospital
Locations
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Research Site
Batumi, , Georgia
Research Site
Tbilisi, , Georgia
Research Site
Tbilisi, , Georgia
Research Site
Tbilisi, , Georgia
Research Site
Tbilisi, , Georgia
Research Site
Aguascalientes, , Mexico
Research Site
Mexico City, , Mexico
Research Site
Derby, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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References
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Hamilton E, Oliveira M, Turner N, Garcia-Corbacho J, Hernando C, Ciruelos EM, Kabos P, Ruiz-Borrego M, Armstrong A, Patel MR, Vaklavas C, Twelves C, Boni V, Incorvati J, Brier T, Gibbons L, Klinowska T, Lindemann JPO, Morrow CJ, Sykes A, Baird RD. A phase I dose escalation and expansion trial of the next-generation oral SERD camizestrant in women with ER-positive, HER2-negative advanced breast cancer: SERENA-1 monotherapy results. Ann Oncol. 2024 Aug;35(8):707-717. doi: 10.1016/j.annonc.2024.04.012. Epub 2024 May 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BreastCancerStudyLocator.com
Other Identifiers
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2020-001079-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D8530C00003
Identifier Type: -
Identifier Source: org_study_id
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