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

Study identifier:D8535C00001

ClinicalTrials.gov identifier:NCT05952557

EudraCT identifier:N/A

CTIS identifier:2023-504031-41

Recruiting

Official Title

CAMBRIA-2: 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

Medical condition

Breast cancer, early breast cancer

Phase

Phase 3

Healthy volunteers

Study drug

Camizestrant, Tamoxifen, Anastrozole, Letrozole, Exemestane, Abemaciclib

Sex

All

Estimated Enrollment

5500

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 05 Oct 2023

Estimated Primary Completion Date: 04 Mar 2030

Estimated Study Completion Date: 06 May 2037

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

Austrian Breast and Colorectal Cancer Study Group (ABCSG)

Inclusion and exclusion 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 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 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 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.

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Arms	Assigned Interventions
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 Tamoxifen. Comparator. Administered orally Drug: Anastrozole Anastrozole. Comparator. Administered orally Drug: Letrozole Letrozole. Comparator. Administered orally Drug: Exemestane Exemestane. Comparator. Administered orally Drug: Abemaciclib Abemaciclib adjuvant treatment Administered orally
Experimental: Arm B: camizestrant ± abemaciclib camizestrant ± abemaciclib	Drug: Camizestrant Camizestrant. Experimental. Administered orally Other Name: AZD9833 Drug: Abemaciclib Abemaciclib adjuvant treatment Administered orally

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]