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A Randomised, Double-Blind, Phase III Study of AZD9833 plus Palbociclib versus Anastrozole plus Palbociclib in Patients with ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease.
EU CTIS ID: 2023-503995-26-00
What this study is testing
To demonstrate superiority of AZD9833 plus palbociclib relative to anastrozole plus palbociclib by assessment of PFS.
- Therapeutic confirmatory (Phase III)
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
- Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment.
- De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.
- Histologically or cytologically documented diagnosis of ER+, HER2- negative breast cancer based on local laboratory results.
- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
- Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
You likely can't join if
- "Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment. "
- Active infection including tuberculosis, HBV and HCV.
- Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant.
- Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Advanced, symptomatic, visceral spread, that are at risk of lifethreatening complications in the short term and/or impending visceral crisis
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
See the full eligibility criteria
Who can join
- Pre-/peri-menopausal women or men can be enrolled if amenable to be treated with concomitant, approved LHRH agonists for the duration of the study treatment.
- De novo Stage 4 disease, or recurrence from early stage disease after at least 24 months of standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of adjuvant AI therapy without disease progression on treatment. Note that a 2-week washout period is required after the last dose of tamoxifen prior to randomisation.
- Histologically or cytologically documented diagnosis of ER+, HER2- negative breast cancer based on local laboratory results.
- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
- Measurable disease as defined per RECIST v.1.1 OR at least one lytic or mixed (lytic + sclerotic) bone lesion with a soft tissue component that can be assessed by CT or MRI.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ and marrow function.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
What rules you out
- "Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment. "
- Active infection including tuberculosis, HBV and HCV.
- Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant.
- Participation in another clinical study with a study treatment or investigational medicinal device administered in the last 4 weeks prior to randomization or concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Advanced, symptomatic, visceral spread, that are at risk of lifethreatening complications in the short term and/or impending visceral crisis
- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
- Any clinically important and symptomatic heart disease.
- Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, renal transplant and active bleeding diseases) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- Any concurrent anti-cancer treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- India
- China
- Russian Federation
- Turkey
- Chile
- Mexico
- Taiwan
- Canada
- Japan
- Malaysia
- United States
- Korea, Republic of
- United Kingdom
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 all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; India; China; Russian Federation; Turkey; Chile and 8 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.