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An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

PHASE3ACTIVE_NOT_RECRUITING

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

Study details:

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria.

Concurrent use of abemaciclib is permitted in both arms. 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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Women and Men; ≥18 years at the time of screening (or per national guidelines)
  2. Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
  3. Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
  4. Patients must be randomised within 12 months of definitive breast surgery.
  5. Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  7. Adequate organ and bone marrow function

Exclusion criteria

  1. Inoperable locally advanced or metastatic breast cancer
  2. Pathological complete response following treatment with neoadjuvant therapy
  3. 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
  4. Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance
  5. Known LVEF <50% with heart failure NYHA Grade ≥2.
  6. Mean resting QTcF interval > 480 ms at screening
  7. Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
  8. Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab)
  9. Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
  10. Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
  11. 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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT05952557

Intervention or treatment

DRUG: Camizestrant

DRUG: Tamoxifen

DRUG: Anastrozole

DRUG: Letrozole

DRUG: Exemestane

DRUG: Abemaciclib

Conditions

  • Breast Cancer, Early Breast Cancer

  • Condition: Breast Cancer, Early Breast Cancer

  • DRUG: Camizestrant and other drugs

  • Adelaide, Australia and more

  • Sponsor: AstraZeneca

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Are you running this trial?

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Research sites nearby

Closest Location:

Research Site

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  • Research Site

    Adelaide, Australia

  • Research Site

    Bankstown, Australia

  • Research Site

    Bendigo, Australia

  • Research Site

    Bowral, Australia

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Who is running the clinical trial?

A

AstraZeneca

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
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
Drug: Tamoxifen, Drug: Anastrozole, Drug: Letrozole, Drug: Exemestane, Drug: Abemaciclib
    EXPERIMENTAL: Arm B: camizestrant ± abemaciclib
    • camizestrant ± abemaciclib
    Drug: Camizestrant, Drug: Abemaciclib

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Invasive breast cancer-free survival (IBCFS)IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer * Death attributable to any cause.Up to 14 years

      Secondary Outcome

      MeasureDescriptionTime Frame
      Invasive disease-free survival (IDFS)IDFS is defined as time from randomisation until date of first occurrence of one of the following events: * Invasive ipsilateral breast tumor recurrence * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer * Second primary non-breast invasive cancer * Death attributable to any cause.Up to 14 years
      Distant relapse-free survival (DRFS)DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.Up to 14 years
      Overall survival (OS)OS is defined as time from randomisation until death from any cause.Up to 14 years
      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)Not SpecifiedUntil 28 days after the final dose of study treatment (up to 7 years)
      Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.Not SpecifiedUntil 28 days after the final dose of study treatment (up to 7 years)
      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-311Not SpecifiedUntil 28 days after the final dose of study treatment (up to 7 years)
      Pharmacokinetics (PK)Plasma concentrations of camizestrant pre-dose (trough concentration)Until 6 months from treatment start
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

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