🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT04214288
Active, not recruiting Phase 2

A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

NCT04214288 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2020-04-22
Last updated
2026-08-26

Condition(s) studied

Advanced ER-Positive HER2-Negative Breast Cancer

Investigational drug(s) / intervention(s)

AZD9833Fulvestrant

AZD9833: Dosage formulation: AZD9833 tablets will be administered orally.

Fulvestrant: Dosage formulation: Fulvestrant will be administered via intramuscular (IM) injection.

Study summary

This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Post-menopausal female patients aged at least 18 years. * Metastatic or loco-regionally recurrent ER-positive HER2-negative adenocarcinoma of the breast. * Radiological or other objective evidence of progression on or after the last systemic therapy prior to starting study treatment. * Patients must have at least 1 lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm in the longest diameter or in absence of measurable disease as defined above, at least 1 lytic or mixed (lytic+sclerotic) bone lesion. * Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1. * Prior endocrine therapy as follows: 1. Recurrence or progression on at least one line of endocrine therapy 2. No more than 1 line of endocrine therapy for advanced disease 3. No more than 1 line of chemotherapy for advanced disease 4. Prior treatment with CDK4/6 inhibitors is permitted 5. No prior treatment with fulvestrant, oral selective oestrogen receptor degrader (SERD), or related therapies * Inclusion criterion for the paired tumour biopsy research subgroup: Washout from prior tamoxifen: 4 months to elapse from last tamoxifen dose to pre-dose on-study biopsy. Exclusion Criteria: Intervention with any of the following: * Any cytotoxic chemotherapy, investigational agents or other anti-cancer drugs for the treatment of breast cancer from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. * Use of systemic oestrogen-containing hormone replacement therapy within 6 months prior to the first dose of study treatment. * Medications or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 3A4/5 and sensitive CYP2B6 substrates, and drugs which are substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index or inability to stop use within the washout period prior to receiving the first dose of study treatment. * Drugs that are known to prolong QT and have a known risk of torsades de pointes. * The following cardiovascular criteria: QTcF \>470 ms, resting heart rate \<45 bpm, clinically significant abnormalities of resting electrocardiogram, uncontrolled hypertension, symptomatic hypotension, factors that increase the risk for QTc prolongation, left ventricular ejection fraction \<50%. * Radiotherapy with a limited field of radiation for palliation within 1 week of dosing, or to \> 30% of bone marrow or a wide field within 4 weeks of dosing. * Major surgical procedure or significant traumatic injury. * Presence of life-threatening metastatic visceral disease or uncontrolled central nervous system metastatic disease. * 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 or fulvestrant. * Previous randomisation in the present study. * Women of childbearing potential.

Primary outcome measure(s)

Trial sites (85)

FacilityCityRegionStatus
Research Site Birmingham Alabama
Research Site Long Beach California
Research Site Fort Myers Florida
Research Site St. Petersburg Florida
Research Site Lincoln Nebraska
Research Site Canton Ohio
Research Site Chattanooga Tennessee
Research Site Nashville Tennessee
Research Site Eagle River Wisconsin
Research Site Brasschaat Belgium
Research Site Charleroi Belgium
Research Site Ghent Belgium
Research Site Haine-Saint-Paul Belgium
Research Site Leuven Belgium
Research Site Libramont-Chevigny Belgium
Research Site Namur Belgium
Research Site Greenfield Park Quebec
Research Site Montreal Quebec
Research Site Montreal Quebec
Research Site Paris France
Research Site Vandœuvre-lès-Nancy France
Research Site Batumi Georgia
Research Site Tbilisi Georgia
Research Site Tbilisi Georgia
Research Site Tbilisi Georgia
Research Site Tbilisi Georgia
Research Site Tbilisi Georgia
Research Site Berlin Germany
Research Site Düsseldorf Germany
Research Site Essen Germany
Research Site Budapest Hungary
Research Site Debrecen Hungary
Research Site Kaposvár Hungary
Research Site Kecskemét Hungary
Research Site Nyíregyháza Hungary
Research Site Pécs Hungary
Research Site Szeged Hungary
Research Site Jerusalem Israel
Research Site Jerusalem Israel
Research Site Nahariya Israel

+ 45 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04214288 on ClinicalTrials.gov ↗ ← All trials in the UK