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RecruitingLast updated: 29 February 2024

CAMBRIA-1: This study is assessing if Camizestrant, a type of hormone therapy, improves outcomes compared to standard hormone therapy in people with ER+/HER2- early breast cancer who have had prior treatmentA 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

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms.

In the Active Comparator Arm, participants will receive standard endocrine (hormone) therapy of the investigator's choice. This will be either Tamoxifen, Anastrozole, Letrozole, or Exemestane).

In the Experimental Arm, participants will receive Camizestrant hormone therapy.

 

Conditions

This trial is treating patients with ER+, HER- 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

Cancer

Breast Cancers Breast

Age

People18 - 130

Phase

III

Trial Acronym

CAMBRIA-1

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific 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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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