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A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy (CAMBRIA-1)

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ClinicalTrials.gov Identifier: NCT05774951
Recruitment Status : Recruiting
First Posted : March 20, 2023
Last Update Posted : April 19, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer, Early Breast Cancer Drug: Camizestrant Drug: Tamoxifen Drug: Anastrozole Drug: Letrozole Drug: Exemestane Phase 3

Detailed Description:

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 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. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).

Patients will be followed for 10 years from randomization of the last patient.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomised in a 1:1 ratio to one of the following arms:

  • Arm A: Continue standard ET of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen)
  • Arm B: Camizestrant
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer
Actual Study Start Date : March 31, 2023
Estimated Primary Completion Date : April 19, 2027
Estimated Study Completion Date : May 29, 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Tamoxifen

Arms and Interventions
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Arm Intervention/treatment
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)
 Drug: Tamoxifen
Tamoxifen. Comparator. Administered per local approved label

Drug: Anastrozole
Anastrozole. Comparator. Administered per local approved label

Drug: Letrozole
Letrozole. Comparator. Administered per local approved label

Drug: Exemestane
Exemestane. Comparator. Administered per local approved label
Experimental: Arm B: camizestrant
Camizestrant
 Drug: Camizestrant
Camizestrant. Experimental. Administered orally
Other Name: AZD9833


Outcome Measures
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Primary Outcome Measures :
  1. Invasive breast cancer-free survival (IBCFS) [ Time Frame: Up to 10 years ]

    IBCFS is defined as time from randomisation until date of first occurrence of:

    • Invasive ipsilateral breast tumour recurrence (invasive IBTR)
    • Locoregional invasive breast cancer recurrence
    • Distant recurrence
    • Invasive contralateral breast cancer
    • Death attributable to any cause.


Secondary Outcome Measures :
  1. Invasive disease-free survival (IDFS) [ Time Frame: Up to 10 years ]

    IDFS is defined as time from randomisation until date of first occurrence of one of the following events:

    • Invasive ipsilateral breast tumor recurrence (invasive IBTR)
    • Locoregional invasive breast cancer recurrence
    • Distant recurrence
    • Invasive contralateral breast cancer
    • Second primary non-breast invasive cancer
    • Death attributable to any cause.

  2. Distant relapse-free survival (DRFS) [ Time Frame: Up to 10 years ]
    DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.

  3. Overall survival (OS) [ Time Frame: Up to 10 years ]
    OS is defined as time from randomisation until death from any cause.

  4. 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) [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  5. Absolute and percent change from baseline in Clinical Laboratory Parameters [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  6. Absolute and percent change from baseline in Vital Sign Parameters [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  7. Number of participants with abnormal physical examinations [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  8. 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) [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  9. 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) [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  10. 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) [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  11. 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) [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  12. 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) [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  13. 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) [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  14. 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) [ Time Frame: Until 28 days after the final dose of study treatment (up to 5 years) ]
  15. Pharmacokinetics (PK) [ Time Frame: Until 6 months from treatment start ]
    • Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05774951


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05774951    
Other Study ID Numbers: D8531C00002
2022-501024-20-00 ( Other Identifier: EMA - CTIS )
First Posted: March 20, 2023    Key Record Dates
Last Update Posted: April 19, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 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 rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: 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
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
ER+
HER2-
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Letrozole
Anastrozole
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents