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

What this trial studies

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.

Conditions in scope

• Advanced ER-Positive HER2-Negative Breast Cancer

Interventions

• AZD9833 (Drug) — Dosage formulation: AZD9833 tablets will be administered orally.
• Fulvestrant (Drug) — Dosage formulation: Fulvestrant will be administered via intramuscular (IM) injection.

Who can join

Women only · Ages 18 Years to 130 Years

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:
• Recurrence or progression on at least one line of endocrine therapy
• No more than 1 line of endocrine therapy for advanced disease

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 86 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2020-04-22
• Primary completion: 2022-08-30
• Last update posted: 2025-11-20
• First posted: 2020-01-02

Sponsor & contact

Lead sponsor: AstraZeneca (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Progression-free Survival (PFS) (From date of randomisation to date of objective disease progression (or last evaluable assessment in the absence of progression) or death (up to data cut-off of 29 months))
  PFS was assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1. PFS was defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or received another anti-cancer therapy prior to progression.…

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