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RecruitingLast updated: 26 April 2024

CAMBRIA-2: This study is comparing how safe and effective a new drug (Camizestrant) is compared to standard endocrine therapy in patients with ER+/HER2- early breast cancer who have an intermediate-high or high risk of recurrence who have undergone surgery (with or without chemotherapy)A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Clinical summary

Summary

This is a randomised adjuvant endocrine-based therapy study that is recruiting participants with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy).

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

  • Active Comparator Arm A: Participants will receive standard endocrine therapy of investigator's choice (exemestane, letrozole, anastrozole or tamoxifen) with or without Abemaciclib, administered orally.
  • Experimental Arm B: Participants will receive Camizestrant with or without Abemaciclib, administered orally

Conditions

This trial is treating patients with ER+/HER2- early breast cancer

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

CAMBRIA-2

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 Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

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 absence of any evidence of metastatic disease 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.
  • Patients must be randomised within 12 months of definitive breast surgery.
  • Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Adequate organ and bone 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 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
  • 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

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

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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