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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05774951




Registration number
NCT05774951
Ethics application status
Date submitted
16/02/2023
Date registered
20/03/2023
Date last updated
7/08/2024

Titles & IDs
Public title
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Scientific title
CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence
Secondary ID [1] 0 0
2022-501024-20-00
Secondary ID [2] 0 0
D8531C00002
Universal Trial Number (UTN)
Trial acronym
CAMBRIA-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

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

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

Experimental: Arm B: camizestrant - Camizestrant


Treatment: Drugs: Camizestrant
Camizestrant. Experimental. Administered orally

Treatment: Drugs: Tamoxifen
Tamoxifen. Comparator. Administered per local approved label

Treatment: Drugs: Anastrozole
Anastrozole. Comparator. Administered per local approved label

Treatment: Drugs: Letrozole
Letrozole. Comparator. Administered per local approved label

Treatment: Drugs: Exemestane
Exemestane. Comparator. Administered per local approved label
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 10 years
Secondary outcome [1] 0 0
Invasive disease-free survival (IDFS)
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [2] 0 0
Distant relapse-free survival (DRFS)
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 10 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 5 years)
Secondary outcome [5] 0 0
Absolute and percent change from baseline in Clinical Laboratory Parameters
Timepoint [5] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [6] 0 0
Absolute and percent change from baseline in Vital Sign Parameters
Timepoint [6] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [7] 0 0
Number of participants with abnormal physical examinations
Timepoint [7] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [8] 0 0
Change from baseline of arthralgia as measured by the EORTC-IL-194 (European Organisation for Research and Treatment of Cancer) item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [8] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [9] 0 0
Change from baseline of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [9] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [10] 0 0
Change from baseline of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [10] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [11] 0 0
Proportion of patients experiencing each level of symptomatic AEs of arthralgia as measured by the EORTC-IL-194 item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [11] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [12] 0 0
Proportion of patients experiencing each level of symptomatic AEs of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [12] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [13] 0 0
Proportion of patients experiencing each level of symptomatic AEs of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse)
Timepoint [13] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [14] 0 0
Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL items from the EORTC-QLQ-C30 items 11 and 12. EORTC-QLQ-C30 uses 0 - 4 scale (higher score is worse)
Timepoint [14] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [15] 0 0
Pharmacokinetics (PK)
Timepoint [15] 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 high or intermediate risk of recurrence, based on clinical-pathological risk features, 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
* Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
* Eastern Cooperative Oncology Group (ECOG) performance status of = 1
* Adequate organ and marrow function
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 at 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
31/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/05/2036
Actual
Sample size
Target
4300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maine
Country [17] 0 0
United States of America
State/province [17] 0 0
Maryland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

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

No information has been provided regarding IPD availability


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/NCT05774951