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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05952557




Registration number
NCT05952557
Ethics application status
Date submitted
17/05/2023
Date registered
19/07/2023

Titles & IDs
Public title
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Scientific title
CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
Secondary ID [1] 0 0
2023-504031-41-00
Secondary ID [2] 0 0
D8535C00001
Universal Trial Number (UTN)
Trial acronym
CAMBRIA-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer, Early Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Camizestrant
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane
Treatment: Drugs - Abemaciclib

Active comparator: Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib - standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib

Experimental: Arm B: camizestrant ± abemaciclib - camizestrant ± abemaciclib


Treatment: Drugs: Camizestrant
Camizestrant. Experimental. Administered orally

Treatment: Drugs: Tamoxifen
Tamoxifen. Comparator. Administered orally

Treatment: Drugs: Anastrozole
Anastrozole. Comparator. Administered orally

Treatment: Drugs: Letrozole
Letrozole. Comparator. Administered orally

Treatment: Drugs: Exemestane
Exemestane. Comparator. Administered orally

Treatment: Drugs: Abemaciclib
Abemaciclib adjuvant treatment Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive breast cancer-free survival (IBCFS)
Timepoint [1] 0 0
Up to 14 years
Secondary outcome [1] 0 0
Invasive disease-free survival (IDFS)
Timepoint [1] 0 0
Up to 14 years
Secondary outcome [2] 0 0
Distant relapse-free survival (DRFS)
Timepoint [2] 0 0
Up to 14 years
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 14 years
Secondary outcome [4] 0 0
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
Timepoint [4] 0 0
Until 28 days after the final dose of study treatment (up to 7 years)
Secondary outcome [5] 0 0
Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.
Timepoint [5] 0 0
Until 28 days after the final dose of study treatment (up to 7 years)
Secondary outcome [6] 0 0
Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311
Timepoint [6] 0 0
Until 28 days after the final dose of study treatment (up to 7 years)
Secondary outcome [7] 0 0
Pharmacokinetics (PK)
Timepoint [7] 0 0
Until 6 months from treatment start

Eligibility
Key inclusion criteria
* Women and Men; =18 years at the time of screening (or per national guidelines)
* Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
* Patients must be randomised within 12 months of definitive breast surgery.
* Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
* Eastern Cooperative Oncology Group (ECOG) performance status of = 1
* Adequate organ and bone marrow function
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inoperable locally advanced or metastatic breast cancer
* Pathological complete response following treatment with neoadjuvant therapy
* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance "
* Known LVEF <50% with heart failure NYHA Grade =2.
* Mean resting QTcF interval > 480 ms at screening
* Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)
* Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/05/2037
Actual
Sample size
Target
5500
Accrual to date
Final
Recruitment in Australia
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2500 - Wollongong
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Hungary
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Hungary
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Gyor
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Hungary
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Kaposvár
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Hungary
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Kecskemét
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Hungary
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Miskolc
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Hungary
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Hungary
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Salgotarjan
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Hungary
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Hungary
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India
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Bangalore
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India
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India
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India
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India
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India
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Israel
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Israel
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Portugal
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Portugal
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Romania
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Romania
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Craiova
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Romania
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Iasi
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Romania
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Romania
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Ovidiu
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Romania
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Pitesti
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Romania
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Sibiu
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Romania
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Frauenfeld
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Bath
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Stockton
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Sutton In Ashfield
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Sutton
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Taunton
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Warwick
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Whitchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austrian Breast and Colorectal Cancer Study Group (ABCSG)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05952557