Clinical trial • Phase III • Oncology
CAMIZESTRANT for Estrogen receptor-positive, HER2-negative advanced breast cancer
Phase III trial of CAMIZESTRANT for Estrogen receptor-positive, HER2-negative advanced breast cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Estrogen receptor-positive, HER2-negative advanced breast cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule | Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 31-01-2024
- First CTIS Authorization Date
- 13-03-2024
Trial design
Randomised, test arm: azd9833 (camizestrant) oral (max daily dose indicated 75 mg) plus palbociclib (oral; max daily dose indicated 125 mg). comparator arm: anastrozole (arimidex®) 1 mg oral daily plus palbociclib (oral; max daily dose indicated 125 mg). placebo to match camizestrant and placebo to match arimidex are listed for blinding.-controlled Phase III trial in Norway, Belgium, Czechia and others.
- Randomised
- Yes
- Comparator
- Test arm: AZD9833 (camizestrant) oral (max daily dose indicated 75 mg) plus palbociclib (oral; max daily dose indicated 125 mg). Comparator arm: Anastrozole (Arimidex®) 1 mg oral daily plus palbociclib (oral; max daily dose indicated 125 mg). Placebo to match camizestrant and placebo to match Arimidex are listed for blinding.
- Target Sample Size
- 822
Eligibility
Recruits 822 adults.
- Pregnancy Exclusion
- Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
Inclusion criteria
- {"criterion_text":"- 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."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Histologically or cytologically documented diagnosis of ER+, HER2- negative breast cancer based on local laboratory results."}
- {"criterion_text":"- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Eastern Cooperative Oncology Group performance status of 0 or 1."}
- {"criterion_text":"- Adequate organ and marrow function."}
- {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures."}
Exclusion criteria
- {"criterion_text":"- \"Previous neoadjuvant or adjuvant treatment with an AI treatment +/- CDK4/6 inhibitor with disease recurrence while on or within 12 months of completing treatment. \""}
- {"criterion_text":"- Prior exposure to AZD9833, other investigational SERDs/endocrine agents or fulvestrant."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Advanced, symptomatic, visceral spread, that are at risk of lifethreatening complications in the short term and/or impending visceral crisis"}
- {"criterion_text":"- Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease."}
- {"criterion_text":"- Any clinically important and symptomatic heart disease."}
- {"criterion_text":"- Currently pregnant (confirmed with positive pregnancy test) or breastfeeding."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Any concurrent anti-cancer treatment."}
- {"criterion_text":"- Active infection including tuberculosis, HBV and HCV."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1.","definition_or_measurement_approach":"Assessed by the Investigator per RECIST version 1.1"}
Secondary endpoints
- {"endpoint_text":"- \"Overall survival (OS) \"","definition_or_measurement_approach":""}
- {"endpoint_text":"- Progression-free survival 2 (PFS2)","definition_or_measurement_approach":""}
- {"endpoint_text":"- \"Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1 \"","definition_or_measurement_approach":"Assessed by the Investigator per RECIST v1.1"}
- {"endpoint_text":"- \"Duration of response (DoR) assessed by the Investigator as defined by RECIST version 1.1 \"","definition_or_measurement_approach":"Assessed by the Investigator per RECIST v1.1"}
- {"endpoint_text":"- Time to second subsequent therapy (TSST)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to chemotherapy (TTC)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to first subsequent anti-cancer therapy (TFST)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Clinical benefit rate at 24 weeks (CBR24)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Plasma concentration of AZD9833 at specified timepoints","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change from baseline in EORTC QLQ-C30 and EORTC QLQ-BR45 scales","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 822
- Recruitment Window Months
- 93
- Consent Approach
- Informed consent is obtained using subject information and informed consent forms (documents listed in the CTIS record). Country-specific ICFs and addenda are provided (adult ICFs, pregnant partner ICFs, genetic and biological sample addenda). No explicit text about assent or minor consent handling is available in the provided record.
Geography
- Total Number Of Sites
- 101
- Total Number Of Participants
- 499
Norway
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 14-03-2024
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Vestre Viken HF
- Department Name
- Onkologisk Poliklinikk
- Principal Investigator Name
- Alina Porojnicu
- Principal Investigator Email
- alinacp@vestreviken.no
- Contact Person Name
- Alina Porojnicu
- Contact Person Email
- alinacp@vestreviken.no
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 22-03-2024
- Processing Time Days
- 37
- Number Of Sites
- 6
- Number Of Participants
- 34
Sites
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Medical Oncology
- Principal Investigator Name
- Stéphanie Henry
- Principal Investigator Email
- stephanie.henry@chuuclnamur.uclouvain.be
- Contact Person Name
- Stéphanie Henry
- Contact Person Email
- stephanie.henry@chuuclnamur.uclouvain.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 13-03-2024
- Processing Time Days
- 28
- Number Of Sites
- 6
- Number Of Participants
- 35
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Onkologická klinika
- Principal Investigator Name
- Kateřina Kopečková
- Principal Investigator Email
- katerina.kopeckova@fnmotol.cz
- Contact Person Name
- Kateřina Kopečková
- Contact Person Email
- katerina.kopeckova@fnmotol.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 15-03-2024
- Processing Time Days
- 30
- Number Of Sites
- 9
- Number Of Participants
- 40
Sites
- Site Name
- MVZ Onkologie Velbert GbR
- Department Name
- Gemeinschaftspraxis Dres. Naser Kalhori Arnd Nusch Werner Langer
- Principal Investigator Name
- Arnd Nusch
- Principal Investigator Email
- nusch@aol.com
- Contact Person Name
- Arnd Nusch
- Contact Person Email
- nusch@aol.com
Poland
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 25-03-2024
- Processing Time Days
- 40
- Number Of Sites
- 6
- Number Of Participants
- 37
Sites
- Site Name
- Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
- Department Name
- Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Dziennej
- Principal Investigator Name
- Bozena Kukielka-Budny
- Principal Investigator Email
- bozena-budny@wp.pl
- Contact Person Name
- Bozena Kukielka-Budny
- Contact Person Email
- bozena-budny@wp.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 13-03-2024
- Processing Time Days
- 28
- Number Of Sites
- 11
- Number Of Participants
- 66
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncology department
- Principal Investigator Name
- Carmen Hinojo Gonzalez
- Principal Investigator Email
- carmen.hinojo@scsalud.es
- Contact Person Name
- Carmen Hinojo Gonzalez
- Contact Person Email
- carmen.hinojo@scsalud.es
Italy
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 25-03-2024
- Processing Time Days
- 40
- Number Of Sites
- 16
- Number Of Participants
- 55
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Ida Paris
- Principal Investigator Email
- ida_paris@yahoo.it
- Contact Person Name
- Ida Paris
- Contact Person Email
- ida_paris@yahoo.it
Austria
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 27-03-2024
- Processing Time Days
- 42
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
- Department Name
- Department of Internal Medicine III
- Principal Investigator Name
- Margit Sandholzer
- Principal Investigator Email
- margit.sandholzer@lkhf.at
- Contact Person Name
- Margit Sandholzer
- Contact Person Email
- margit.sandholzer@lkhf.at
Hungary
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 18-03-2024
- Processing Time Days
- 33
- Number Of Sites
- 9
- Number Of Participants
- 35
Sites
- Site Name
- Central Hospital Of Northern Pest Military Hospital
- Department Name
- Onkologiai Osztaly
- Principal Investigator Name
- Zsuzsanna Papai
- Principal Investigator Email
- trial.zspapai@gmail.com
- Contact Person Name
- Zsuzsanna Papai
- Contact Person Email
- trial.zspapai@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 04-04-2024
- Processing Time Days
- 50
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- Site Name
- MC Nadezhda Clinical
- Principal Investigator Name
- Mila Petrova
- Principal Investigator Email
- milllapetrova@gmail.com
- Contact Person Name
- Mila Petrova
- Contact Person Email
- milllapetrova@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 15-03-2024
- Processing Time Days
- 30
- Number Of Sites
- 12
- Number Of Participants
- 42
Sites
- Site Name
- Medipole De Nancy
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Laurene Gavoille
- Principal Investigator Email
- l.gavoille@ilcgroupe.fr
- Contact Person Name
- Laurene Gavoille
- Contact Person Email
- l.gavoille@ilcgroupe.fr
Slovakia
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 13-03-2024
- Processing Time Days
- 28
- Number Of Sites
- 5
- Number Of Participants
- 45
Sites
- Site Name
- Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
- Department Name
- Outpatient care of clinical oncology
- Principal Investigator Name
- Jaroslava Lešková
- Principal Investigator Email
- leskova.j@fnsppresov.sk
- Contact Person Name
- Jaroslava Lešková
- Contact Person Email
- leskova.j@fnsppresov.sk
Portugal
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 13-03-2024
- Processing Time Days
- 29
- Number Of Sites
- 11
- Number Of Participants
- 60
Sites
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Oncology Department
- Principal Investigator Name
- Marta Almeida
- Principal Investigator Email
- marta.almeida@hb.min-saude.pt
- Contact Person Name
- Marta Almeida
- Contact Person Email
- marta.almeida@hb.min-saude.pt
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Camizestrant
- Active Substance
- CAMIZESTRANT
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 1
- Maximum Dose
- 75 mg (maxDailyDoseAmount 75)
- Investigational Product Name
- IBRANCE (palbociclib) formulations
- Active Substance
- PALBOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 2
- Dose Levels
- 75 mg / 100 mg / 125 mg formulations listed
- Maximum Dose
- 125 mg (maxDailyDoseAmount 125)
- Investigational Product Name
- Arimidex® (anastrozole)
- Active Substance
- ANASTROZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 2
- Frequency
- Daily (maxDailyDoseAmount 1 mg)
- Maximum Dose
- 1 mg (maxDailyDoseAmount 1)
- Investigational Product Name
- LEUPRORELIN ACETATE
- Active Substance
- LEUPRORELIN ACETATE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAMUSCULAR
- Route
- INTRAMUSCULAR
- Authorisation Status
- prodAuthStatus 2
- Maximum Dose
- 0.13 mg (maxDailyDoseAmount 0.13)
- Investigational Product Name
- GOSERELIN ACETATE
- Active Substance
- GOSERELIN ACETATE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- prodAuthStatus 2
- Maximum Dose
- 0.12 mg (maxDailyDoseAmount 0.12)
- Investigational Product Name
- Placebo to match camizestrant
- Modality
- Other
- Investigational Product Name
- Placebo to match Arimidex
- Modality
- Other
- Combination Treatment
- Yes
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