Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:26 PM
Study NCT ID:
NCT07427394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722187', 'term': 'AZD9833'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs) and serious AEs', 'timeFrame': 'Up to Post-Treatment Follow up (Day 30 Post Dose)', 'description': 'To investigate the safety and tolerability of camizestrant in combination with atirmociclib.'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration observed (Cmax)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterize the PK profile and parameters of atirmociclib.'}, {'measure': 'Area under plasma concentration-time curve from time 0 to infinity (AUCinf)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterize the PK profile and parameters of atirmociclib.'}, {'measure': 'Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterize the PK profile and parameters of atirmociclib.'}, {'measure': 'Time to reach maximum (peak) plasma concentration following drug administration (tmax)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterize the PK profile and parameters of atirmociclib.'}, {'measure': 'Terminal elimination rate constant (λz)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterize the PK profile and parameters of atirmociclib.'}, {'measure': 'Terminal elimination half-life (t½λz)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterize the PK profile and parameters of atirmociclib.'}, {'measure': 'Apparent total body clearance (CL/F)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterize the PK profile and parameters of atirmociclib.'}, {'measure': 'Apparent volume of distribution at steady state (Vss/F)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterize the PK profile and parameters of atirmociclib.'}, {'measure': 'Apparent volume of distribution based on the terminal phase (Vz/F)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterize the PK profile and parameters of atirmociclib.'}, {'measure': 'Maximum concentration observed at steady state (Cssmax)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other.'}, {'measure': 'Area under the curve from 0 to the end of dosing interval (AUC0-tau)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other.'}, {'measure': 'Area under the curve from 0 to the end of dosing interval at steady state (AUCss0-tau)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other.'}, {'measure': 'Time to reach maximum plasma concentration at steady state (tssmax)', 'timeFrame': 'At pre-defined intervals from Day -1 to Day 57', 'description': 'To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 2 years', 'description': 'To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 2 years', 'description': 'To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.'}, {'measure': 'Clinical Benefit Rate at 24 Weeks (CBR24)', 'timeFrame': 'At 24 weeks', 'description': 'To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.'}, {'measure': 'Percentage change in tumor size', 'timeFrame': 'Up to 2 years', 'description': 'To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.'}, {'measure': 'Progression-free survival landmark 6 months (PFSLM6m)', 'timeFrame': 'At 6 months', 'description': 'To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.'}, {'measure': 'Progression-free survival landmark 12 months (PFSLM12m)', 'timeFrame': 'At 12 months', 'description': 'To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Estrogen receptor (ER)-positive', 'Human epidermal growth factor receptor 2 (HER2)-negative', 'Cyclin-Dependent Kinase (CDK) 4 inhibitors', 'Pharmacokinetics', 'Anti-tumor activity', 'Selective Estrogen Receptor Degrader (SERD)', 'Safety', 'Tolerability'], 'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.', 'detailedDescription': 'This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib.\n\nThe single-arm study includes:\n\n* Screening period\n* Atirmociclib single dose period\n* Doublet intervention period\n* Post-treatment follow-up period'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females with ER-positive HER2-negative ABC and who have experienced disease progression on a CDK4/6 inhibitor in combination with endocrine therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.\n* Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.\n* Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.\n* At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.\n* Menopausal status\n\n * Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.\n * Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age \\<60 years with ≥12 months amenorrhea and post-menopausal hormone levels.\n* Histological or cytological confirmation of adenocarcinoma of the breast.\n* Participants of childbearing potential must agree to use one highly effective contraceptive measure.\n* Documentation of ER-positive tumor irrespective of progesterone receptor status.\n\nMain Exclusion Criteria:\n\n* A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting.\n* A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.\n* Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.\n* Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.\n* Inability to swallow oral medications.\n* Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).\n* Presence of life-threatening metastatic visceral disease.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.'}, 'identificationModule': {'nctId': 'NCT07427394', 'acronym': 'SERENA-1b', 'briefTitle': 'Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)', 'orgStudyIdInfo': {'id': 'D853CC00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Camizestrant + Atirmociclib', 'description': 'Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1.', 'interventionNames': ['Drug: Camizestrant', 'Drug: Atirmociclib']}], 'interventions': [{'name': 'Camizestrant', 'type': 'DRUG', 'description': 'Camizestrant will be administered orally.', 'armGroupLabels': ['Camizestrant + Atirmociclib']}, {'name': 'Atirmociclib', 'type': 'DRUG', 'description': 'Atirmociclib will be administered orally.', 'armGroupLabels': ['Camizestrant + Atirmociclib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '02915', 'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'EC1M6BQ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4GJ', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}