A Study to Investigate the Biological Effects of AZD9833 in Women with ER-positive, HER2 Negative Primary Breast Cancer - SERENA-3

Study identifier:D8530C00003

ClinicalTrials.gov identifier:NCT04588298

EudraCT identifier:2020-001079-33

CTIS identifier:N/A

Study Complete

Official Title

A Randomised, Open-Label, Parallel-Group, Pre-surgical Study to Investigate the Biological Effects of AZD9833 in Women with ER-positive, HER2-negative Primary Breast Cancer (SERENA-3)

Medical condition

HER2-negative breast cancer

Phase

Phase 2

Healthy volunteers

Study drug

AZD9833

Sex

Female

Actual Enrollment

135

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 02 Nov 2020

Primary Completion Date: 19 Jun 2023

Study Completion Date: 19 Jun 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

• Provision of written informed consent prior to study entry
• Female participants aged at least 18 years
• Post-menopausal status defined as meeting at least one of the following criteria:
(a) Have undergone a bilateral oophorectomy
(b) Age ≥ 60 years
(c) 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:
(a) ER positive breast cancer
(b) HER2-negative breast cancer
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria

• Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments)
• Intervention with any of the following:
a) Use of sex-hormone-containing drugs within 6 months prior to the first dose of study treatment
b) 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
c) 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

No locations available

Arms	Assigned Interventions
Experimental: Stage 1: AZD9833 Dose A Post-menopausal participants will receive once daily oral dose A of AZD9833 in stage 1 of the study.	Drug: AZD9833 AZD9833 tablets will be administered orally.
Experimental: Stage 1: AZD9833 Dose B Post-menopausal participants will receive once daily oral dose B of AZD9833 in stage 1 of the study.	Drug: AZD9833 AZD9833 tablets will be administered orally.
Experimental: Stage 2: AZD9833 Dose A Post-menopausal participants will receive once daily oral dose A of AZD9833 in stage 2 of the study.	Drug: AZD9833 AZD9833 tablets will be administered orally.
Experimental: Stage 2: AZD9833 Dose B Post-menopausal participants will receive once daily oral dose B of AZD9833 in stage 2 of the study.	Drug: AZD9833 AZD9833 tablets will be administered orally.
Experimental: Stage 2: AZD9833 Dose C Post-menopausal participants will receive once daily oral dose C of AZD9833 in stage 2 of the study.	Drug: AZD9833 AZD9833 tablets will be administered orally.
Experimental: Stage 3: AZD9833 Dose A Post-menopausal participants will receive once daily oral dose A of AZD9833 in stage 3 of the study.	Drug: AZD9833 AZD9833 tablets will be administered orally.
Experimental: Stage 3: AZD9833: Dose B Post-menopausal participants will receive once daily oral dose B of AZD9833 in stage 3 of the study.	Drug: AZD9833 AZD9833 tablets will be administered orally.

Documents available

BreastCancerStudyLocator.com
Download
CSP_Redacted
Download
SAP_Redacted
Download
CSR Synopsis Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

AZ Breast Cancer Study Navigators

+1-877-400-4656

[email protected]

Investigators

Principal Investigator

John Robertson

Graduate Entry Medicine & Health School, University of Nottingham, Royal Derby Hospital