Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer MedDRA version: 21.1 Level: LLT Classification code 10072737 Term: Advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: AZD9833- 25 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Camizestrant
CAS Number: 2222844-89-3
Current Sponsor code: AZD9833
Concentration unit: mg milligram(s)
Concen
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 standard adjuvant endocrine therapy meeting either one of the following criteria: (a) Received at least 24 months of AI treatment as part of their adjuvant therapy and at least 12 months have elapsed since the patient’s last dose of adjuvant AI therapy without disease progression on treatment. (b) Received at least 24 months of tamoxifen treatment as part of their adjuvant endocrine therapy - 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 872 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 470
Exclusion criteria
Exclusion criteria: - Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment. - Previous treatment with AZD9833. - 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 life-threatening complications in the short term. - 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 breast-feeding. - 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 above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of AZD9833 plus palbociclib relative to anastrozole plus palbociclib by assessment of PFS.;Secondary Objective: To demonstrate superiority of AZD9833 plus palbociclib relative to anastrozole plus palbociclib by assessment of OS and second progression free survival. To estimate the effectiveness of AZD9833 plus palbociclib relative to anastrozole plus palbociclib by assessment of ORR, DoR, clinical benefit rate at 24 weeks, time to chemotherapy, time to first subsequent therapy or death and time to second subsequent therapy or death. To assess the steady state PK of AZD9833 in combination with palbociclib in all participants who receive at least one dose of AZD9833 per the protocol, for whom there are at least one reportable PK concentration. To assess symptoms, functioning, and health-related quality of life in participants treated with AZD9833 plus palbociclib compared with anastrozole plus palbociclib using the EORTC QLQ-C30 and EORTC QLQ-BR45 questionnaires.;Primary end point(s): Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1.;Timepoint(s) of evaluation of this end point: From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival (OS) 2. Progression-free survival 2 (PFS2) 3. Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1 4. Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1 5. Time to second subsequent therapy (TSST) 6. Time to chemotherapy (TTC) 7. Time to first subsequent anti-cancer therapy (TFST) 8. Clinical benefit rate at 24 weeks (CBR24) 9. Plasma concentration of AZD9833 at specified timepoints 10. Change from baseline in EORTC QLQ-C30 and EORTC QLQ-BR45 scales;Timepoint(s) of evaluation of this end point: 1. Up to approximately 8 years 2-7. Up to approximately 5 years 8. At Week 24 9. On Day 15 10. Up to approximately 5 years | — |
Countries
Austria, Belgium, Bulgaria, Canada, China, Czechia, Czech Republic, Finland, France, Germany, Hungary, India, Italy, Japan, Norway, Poland, Portugal, Russian Federation, Slovakia, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed