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A trial to learn how camizestrant (AZD9833) works compared to fulvestrant and how safe it is in women with advanced breast cancer who have gone through menopause.
EU CTIS ID: 2023-504974-40-00
What this study is testing
To determine the clinical efficacy (as assessed by PFS) of AZD9833 when compared to fulvestrant in women with advanced ER-positive HER2-negative breast cancer.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provision of signed and dated, written informed consent prior to any mandatory study specific procedures, sampling, and analyses. Patients are also required to consent to the provision of archival tumour biopsies.
- 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.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.
- For patients who consent, provision of signed and dated written informed consent prior to collection of sample for analysis.
- Female patients aged at least 18 years.
You likely can't join if
- 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.
- 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.
- Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
See the full eligibility criteria
- Provision of signed and dated, written informed consent prior to any mandatory study specific procedures, sampling, and analyses. Patients are also required to consent to the provision of archival tumour biopsies.
- 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.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.
- For patients who consent, provision of signed and dated written informed consent prior to collection of sample for analysis.
- Female patients aged at least 18 years.
- Post-menopausal as per the defined criteria.
- Histologically or cytological confirmation of adenocarcinoma of the breast.
- ER-positive status of primary or metastatic tumour tissue.
- HER2-negative
- Metastatic disease or loco-regionally recurrent disease suitable for treatment with fulvestrant.
- Radiological or other objective evidence of progression on or after the last systemic therapy prior to starting study treatment.
- 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.
- 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.
- Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Patients with known active hepatitis (i.e. hepatitis B or C).
- 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 and as specified in Appendix B of the protocol, prior to receiving the first dose of study treatment.
- Drugs as indicated in Appendix B1 of the protocol.
- Any cardiovascular criteria described in the protocol.
- Radiotherapy with a limited field of radiation for palliation.
- Major surgical procedure or significant traumatic injury.
- Presence of life-threatening metastatic visceral disease or uncontrolled central nervous system (CNS) metastatic disease.
- Inadequate bone marrow reserve or organ function.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Georgia
- Ukraine
- Mexico
- Israel
- Korea, Republic of
- Russian Federation
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Georgia; Ukraine; Mexico; Israel and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.