Comparing Tamoxifen with Camizestrant for early breast cancer breast cancer
Official title: A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
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
Interventions
Camizestrant
Camizestrant. Experimental. Administered orally
Tamoxifen
Tamoxifen. Comparator. Administered per local approved label
Anastrozole
Anastrozole. Comparator. Administered per local approved label
Letrozole
Letrozole. Comparator. Administered per local approved label
Exemestane
Exemestane. Comparator. Administered per local approved label
Canadian Sites (14)
Research Site
Calgary, Alberta, Canada
Research Site
Kelowna, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Barrie, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Sault Ste. Marie, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Saint-Jérôme, Quebec, Canada
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Women and Men, ≥18 years at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (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 protocolProtocolThe detailed plan a study must follow.Read more →.
- +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
- +Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
Exclusion
- −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
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Any concurrent anti-cancer treatment not specified in the protocolProtocolThe detailed plan a study must follow.Read more → 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
- −Concurrent exogenous sex hormone therapy
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Camizestrant, Tamoxifen, Anastrozole, Letrozole, and 1 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 130 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 4,300 people.
The study is currently expected to finish around May 2036.
The main measurement is taken over: Up to 10 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Invasive breast cancer-free survival (IBCFS) — measured over Up to 10 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05774951 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CamizestrantDrug
Camizestrant. Experimental. Administered orally
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About TamoxifenDrug
Tamoxifen. Comparator. Administered per local approved label
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About AnastrozoleDrug
Anastrozole. Comparator. Administered per local approved label
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About LetrozoleDrug
Letrozole. Comparator. Administered per local approved label
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About ExemestaneDrug
Exemestane. Comparator. Administered per local approved label
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 130 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 130 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 10 years.
The study as a whole is currently expected to finish around 2036-05-29.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 4,300 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 26 locations, including: Calgary, Alberta, Canada; Kelowna, British Columbia, Canada; Winnipeg, Manitoba, Canada; Barrie, Ontario, Canada; Ottawa, Ontario, Canada; Sault Ste. Marie, Ontario, Canada, and 20 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
Other Sites (17)
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
East Lansing, Michigan, United States
Research Site
Lansing, Michigan, United States
Research Site
Royal Oak, Michigan, United States
Research Site
East Syracuse, New York, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Stony Brook, New York, United States
Research Site
The Bronx, New York, United States
Research Site
White Plains, New York, United States
Research Site
Seattle, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Spokane, Washington, United States
Research Site
Tacoma, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.