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Joint Clinical Trials Office

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next-Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment

Clinical Trial 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).

Camizestrant is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). 

Participants will be randomized to receive either camizestrant or standard adjuvant endocrine therapy. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

All participants will receive the same dose of the medications which are taken orally.

The planned duration of treatment in either arm within the study will be 7 years. Patients will be followed for 10 years from randomization of the last patient.

Key Eligibility: 

Inclusion Criteria:

  1.  Women and Men; over 18 years of age
  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 therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.

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 judgment) unless in complete remission with no therapy for a minimum of 5 years from the date of randomization

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Devonie Manzano, RN
212-746-7117
dgm4004@med.cornell.edu

Primary Investigator(s)

Massimo Cristofanilli, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2310026632

ClinicalTrials.gov:

NCT05952557

Sponsor:

CAMBRIA-2

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • AstraZeneca

Disease

Breast Cancer