A Phase 1 Study of AZD9833 in Japanese Women with ER Positive, HER2 Negative Advanced Breast Cancer

Study identifier:D8530C00006

ClinicalTrials.gov identifier:NCT04541433

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase 1, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti- tumor Activity of AZD9833 in Japanese Women with ER Positive, HER2 Negative Advanced Breast Cancer

Medical condition

ER+ HER2- Advanced Breast Cancer

Phase

Phase 1

Healthy volunteers

Study drug

AZD9833

Sex

Female

Actual Enrollment

Study type

Interventional

Age

20 Years - 130 Years

Date

Study Start Date: 29 Sept 2020

Primary Completion Date: 29 Jul 2022

Estimated Study Completion Date: 31 Dec 2025

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Signed written informed consent.
2. >= 20 years.
3. Any menopausal status:
Pre and Post menopausal defined according to standard criteria in the protocol.
4. Histological or cytological confirmation of adenocarcinoma of the breast.
5. Documented positive estrogen receptor status of primary or metastatic tumor tissue, according to the local laboratory parameters. HER-2 negative.
6. Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting IMP.
7. Prior chemotherapy, endocrine therapy and other therapy in the advanced setting is restricted as follows:
a. No more than 2 lines of chemotherapy for advanced disease.
b. Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
c. There is no limit on the number of lines of prior endocrine therapies.
d. Prior treatment with CDK4/6 inhibitors is permitted.
8. At least one lesion (measurable and/or non-measurable, as per RECIST 1.1) that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray; or clinical examination.
9. Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1
Major

Exclusion Criteria

1. Intervention with any of the following:
a. Any cytotoxic chemotherapy, investigational agents, or other anti-cancer drugs for the treatment of advanced breast cancer from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
b. Medications or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 (CYP) 3A4/5 sensitive CYP2B6 substrates and drugs which are substrates of CYP2C9 and/or CYP2C19.
c. Drugs that are known to prolong QT and have a known risk of Torsades de Pointes.
d. Radiotherapy with a limited field of radiation for palliation within one week of the first dose of IMP, radiotherapy to more than 30% of the bone marrow or a wide field of radiation within 4 weeks of the first dose of IMP.
e. Major surgical procedure or significant traumatic injury.
2. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting IMP.
3. Presence of life-threatening metastatic visceral disease.
4. Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.
5. 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.
6. History of another primary malignancy.
7. Male subjects are excluded from this study.
8. History of hypersensitivity to active or inactive excipients of AZD9833.
9. 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%.
10. Inadequate bone marrow reserve or organ function
11. Involvement in the planning and conduct of the study.
12. Judgment by the investigator that the patient should not participate in the study.

No locations available

Arms	Assigned Interventions
Experimental: AZD9833 monotherapy Dose escalation of AZD9833 monotherapy for patients with ER+ HER2- advanced breast cancer	-

Documents available

http://BreastCancerStudyLocator.com
Download
Redacted CSR synopsis
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