Clinical trial • Phase II • Oncology
CAMIZESTRANT for Estrogen receptor-positive HER2-negative advanced breast cancer
Phase II 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 II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-07-2024
- First CTIS Authorization Date
- 09-09-2024
Trial design
Randomised, open-label, fulvestrant — solution for injection, intramuscular use; max daily dose 500 mg (dose unit mg provided); schedule not specified in the provided record.-controlled Phase II trial in Belgium, France, Hungary and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Fulvestrant — solution for injection, intramuscular use; max daily dose 500 mg (dose unit mg provided); schedule not specified in the provided record.
- Target Sample Size
- 99
Eligibility
Recruits 99 No vulnerable populations selected. Participants are adults (female patients aged at least 18 years) and must provide signed and dated written informed consent prior to any study-specific procedures; separate consent is required for provision of archival tumour biopsies and for sample collection for analyses. Assent procedures are not applicable..
- Pregnancy Exclusion
- Women of childbearing potential.
- Vulnerable Population
- No vulnerable populations selected. Participants are adults (female patients aged at least 18 years) and must provide signed and dated written informed consent prior to any study-specific procedures; separate consent is required for provision of archival tumour biopsies and for sample collection for analyses. Assent procedures are not applicable.
Inclusion criteria
- {"criterion_text":"- 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.\n- 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.\n- Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1.Inclusion criterion for the paired tumour biopsy research subgroup.\n- Washout from prior tamoxifen: 4 months to elapse from last tamoxifen dose to pre-dose on-study biopsy.\n- For patients who consent, provision of signed and dated written informed consent prior to collection of sample for analysis.\n- Female patients aged at least 18 years.\n- Post-menopausal as per the defined criteria.\n- Histologically or cytological confirmation of adenocarcinoma of the breast.\n- ER-positive status of primary or metastatic tumour tissue.\n- HER2-negative\n- Metastatic disease or loco-regionally recurrent disease suitable for treatment with fulvestrant.\n- Radiological or other objective evidence of progression on or after the last systemic therapy prior to starting study treatment."}
Exclusion criteria
- {"criterion_text":"- 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.\n- 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.\n- History of hypersensitivity to active or inactive excipients of AZD9833 or fulvestrant.\n- Previous randomisation in the present study.\n- Women of childbearing potential.\n- Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV).\n- Patients with known active hepatitis (i.e. hepatitis B or C).\n- Use of systemic oestrogen-containing hormone replacement therapy within 6 months prior to the first dose of study treatment.\n- 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.\n- Drugs as indicated in Appendix B1 of the protocol.\n- Any cardiovascular criteria described in the protocol.\n- Radiotherapy with a limited field of radiation for palliation.\n- Major surgical procedure or significant traumatic injury.\n- Presence of life-threatening metastatic visceral disease or uncontrolled central nervous system (CNS) metastatic disease.\n- Inadequate bone marrow reserve or organ function."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free survival","definition_or_measurement_approach":"Progression-free survival (PFS) as the clinical efficacy primary endpoint; assessed per protocol (PFS)."}
Secondary endpoints
- {"endpoint_text":"- Objective response rate","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of response","definition_or_measurement_approach":""}
- {"endpoint_text":"- Percentage change in tumour size in tumour size at 16 weeks","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
- {"endpoint_text":"- Clinical benefit rate at 24 weeks","definition_or_measurement_approach":""}
- {"endpoint_text":"- Plasma concentrations of AZD9833 and, if appropriate, metabolite(s)","definition_or_measurement_approach":"Measurement of plasma concentrations of AZD9833 and, where appropriate, metabolite(s) per PK sampling schedule."}
- {"endpoint_text":"- Percent change from baseline in ER and progesterone receptor (PgR) expression assessed by the manual H-score method","definition_or_measurement_approach":"Expression changes assessed by manual H-score method on tumour tissue."}
- {"endpoint_text":"- Percent change from baseline in Ki67 labelling index.","definition_or_measurement_approach":"Ki67 labelling index percent change from baseline measured on tumour samples."}
- {"endpoint_text":"- Changes from baseline in total/subscale scores of the HrQoL questionnaires.","definition_or_measurement_approach":"Health-related quality of life changes assessed by patient-completed HRQoL questionnaires (specified instruments in protocol)."}
Recruitment
- Planned Sample Size
- 99
- Recruitment Window Months
- 74
- Consent Approach
- Signed and dated written informed consent is required prior to any mandatory study-specific procedures, sampling, and analyses. Separate consents are required for archival tumour biopsies and for collection of samples for analysis (where patients consent). Consent materials and subject information/informed consent forms are available in multiple languages (documents in the record include English, French, Polish, Italian, Dutch, Russian and others as per country-specific ICFs). Participants are adults (≥18) and provide consent themselves; assent procedures are not applicable.
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 30
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 09-09-2024
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Hopital De Libramont
- Department Name
- #1001: Oncologie
- Principal Investigator Name
- Frédéric Forget
- Principal Investigator Email
- frederic.forget@vivalia.be
- Contact Person Name
- Frédéric Forget
- Contact Person Email
- frederic.forget@vivalia.be
- Site Name
- CHU Helora
- Department Name
- #1006: Onco-Hématologie
- Principal Investigator Name
- Caterina Confente
- Principal Investigator Email
- caterina.confente@jolimont.be
- Contact Person Name
- Caterina Confente
- Contact Person Email
- caterina.confente@jolimont.be
- Site Name
- Algemeen Ziekenhuis Klina
- Department Name
- #1000: Oncologie
- Principal Investigator Name
- Didier Verhoeven
- Principal Investigator Email
- didier.verhoeven@klina.be
- Contact Person Name
- Didier Verhoeven
- Contact Person Email
- didier.verhoeven@klina.be
- Site Name
- UZ Leuven
- Department Name
- #1004: Gynaecologische Oncologie
- Principal Investigator Name
- Patrick Neven
- Principal Investigator Email
- patrick.neven@uzleuven.be
- Contact Person Name
- Patrick Neven
- Contact Person Email
- patrick.neven@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 13-09-2024
- Processing Time Days
- 32
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- #1205: Service d’Oncologie Médicale
- Principal Investigator Name
- Vincent Massard
- Principal Investigator Email
- v.massard@nancy.unicancer.fr
- Contact Person Name
- Vincent Massard
- Contact Person Email
- v.massard@nancy.unicancer.fr
- Site Name
- Institut Curie
- Department Name
- #1202: Département d'Oncologie Médicale
- Principal Investigator Name
- Francois-Clement Bidard
- Principal Investigator Email
- francois-clement.bidard@curie.fr
- Contact Person Name
- Francois-Clement Bidard
- Contact Person Email
- francois-clement.bidard@curie.fr
Hungary
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 10-09-2024
- Processing Time Days
- 29
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- University Of Pecs
- Department Name
- #1504: Onkoterápiás Intézet
- Principal Investigator Name
- László Csaba Mangel
- Principal Investigator Email
- mangel.laszlo.study@pte.hu
- Contact Person Name
- László Csaba Mangel
- Contact Person Email
- mangel.laszlo.study@pte.hu
- Site Name
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
- Department Name
- #1502: Onkoradiológia
- Principal Investigator Name
- Ágnes Weber
- Principal Investigator Email
- mezeiklara62@gmail.com
- Contact Person Name
- Ágnes Weber
- Contact Person Email
- mezeiklara62@gmail.com
- Site Name
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
- Department Name
- #1506: Klinikai Onkológiai Osztály
- Principal Investigator Name
- András Bálint
- Principal Investigator Email
- andrasbalint@freemail.hu
- Contact Person Name
- András Bálint
- Contact Person Email
- andrasbalint@freemail.hu
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- #1500: "B" Belgyógyászati-Onkológiai Osztály és Klinikai Farmakológiai Osztály
- Principal Investigator Name
- Gábor Rubovszky
- Principal Investigator Email
- garub@oncol.hu
- Contact Person Name
- Gábor Rubovszky
- Contact Person Email
- garub@oncol.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 14-04-2025
- Processing Time Days
- 245
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- #1703: Unità Operativa Oncologia Medica
- Principal Investigator Name
- Michela Palleschi
- Principal Investigator Email
- michela.palleschi@irst.emr.it
- Contact Person Name
- Michela Palleschi
- Contact Person Email
- michela.palleschi@irst.emr.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- #1704: "Struttura Complessa Oncologia Clinica Sperimentale di Senologia"
- Principal Investigator Name
- Michelino De Laurentiis
- Principal Investigator Email
- delauren@breastunit.org
- Contact Person Name
- Michelino De Laurentiis
- Contact Person Email
- delauren@breastunit.org
- Site Name
- Azienda Ospedaliera Papardo
- Department Name
- #1709: Unità Operativa Oncologia Medica
- Principal Investigator Name
- Giuseppina Ricciardi
- Principal Investigator Email
- ricciardi.giusy81@gmail.com
- Contact Person Name
- Giuseppina Ricciardi
- Contact Person Email
- ricciardi.giusy81@gmail.com
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- #1701: Divisione di Senologia Medica
- Principal Investigator Name
- Marco Colleoni
- Principal Investigator Email
- marco.colleoni@ieo.it
- Contact Person Name
- Marco Colleoni
- Contact Person Email
- marco.colleoni@ieo.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- #1705: SSD Oncol.Med. Addarii-Zamagni
- Principal Investigator Name
- Claudio Zamagni
- Principal Investigator Email
- claudio.zamagni@aosp.bo.it
- Contact Person Name
- Claudio Zamagni
- Contact Person Email
- claudio.zamagni@aosp.bo.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- #1700: Struttura Complessa di Oncologia Medica
- Principal Investigator Name
- Gabriella Farina
- Principal Investigator Email
- gabriella.farina@asst-fbf-sacco.it
- Contact Person Name
- Gabriella Farina
- Contact Person Email
- gabriella.farina@asst-fbf-sacco.it
- Site Name
- Azienda Ospedaliera Papardo
- Department Name
- #1709: Unità Operativa Oncologia Medica
- Principal Investigator Name
- Michelino De Laurentiis
- Principal Investigator Email
- delauren@breastunit.org
- Contact Person Name
- Michelino De Laurentiis
- Contact Person Email
- delauren@breastunit.org
Portugal
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 12-09-2024
- Processing Time Days
- 31
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Champalimaud Clinical Centre
- Department Name
- #2202: Unidade de Mama
- Principal Investigator Name
- Fatima Cardoso
- Principal Investigator Email
- fatimacardoso@fundacaochampalimaud.pt
- Contact Person Name
- Fatima Cardoso
- Contact Person Email
- fatimacardoso@fundacaochampalimaud.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 11-09-2024
- Processing Time Days
- 30
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #2400: Oncología Médica
- Principal Investigator Name
- Ana Antunes Melo Oliveira
- Principal Investigator Email
- moliveira@vhio.net
- Contact Person Name
- Ana Antunes Melo Oliveira
- Contact Person Email
- moliveira@vhio.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- #2409: Oncología
- Principal Investigator Name
- Eva María Ciruelos Gil
- Principal Investigator Email
- emciruelos@hmhospitales.com
- Contact Person Name
- Eva María Ciruelos Gil
- Contact Person Email
- emciruelos@hmhospitales.com
Poland
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 22-04-2025
- Processing Time Days
- 253
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Pratia S.A.
- Department Name
- #2105: Oncology
- Principal Investigator Name
- Renata Szoszkiewicz
- Principal Investigator Email
- rszoszkiewicz@pratia.pl
- Contact Person Name
- Renata Szoszkiewicz
- Contact Person Email
- rszoszkiewicz@pratia.pl
- Site Name
- Mruk-Med I Sp. z o.o.
- Department Name
- #2103: Oncology
- Principal Investigator Name
- Andrzej Mruk
- Principal Investigator Email
- kmruk1@vp.pl
- Contact Person Name
- Andrzej Mruk
- Contact Person Email
- kmruk1@vp.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- #2101:Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej
- Principal Investigator Name
- Zbigniew Nowecki
- Principal Investigator Email
- Zbigniew.Nowecki@pib-nio.pl
- Contact Person Name
- Zbigniew Nowecki
- Contact Person Email
- Zbigniew.Nowecki@pib-nio.pl
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- 1|10|11|13|5|6|8
Third parties
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"1|10|11|13|5|6|8","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- camizestrant
- Active Substance
- CAMIZESTRANT
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- 1
- Maximum Dose
- 300 mg
- Investigational Product Name
- FULVESTRANT
- Active Substance
- FULVESTRANT
- Modality
- Small molecule
- Routes Of Administration
- INTRAMUSCULAR USE
- Route
- INTRAMUSCULAR
- Authorisation Status
- 2
- Maximum Dose
- 500 mg
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