Recruiting NCT05952557

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

Phase III Interventional Breast Cancer, Early Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Camizestrant, Tamoxifen, Anastrozole, Letrozole.
Who it may be relevant to: Registry conditions: Breast Cancer, Early Breast Cancer. Basic parameters: 18 years — 130 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +39
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

Detailed description

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.

Interventions

Drug Camizestrant
Camizestrant. Experimental. Administered orally
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

Primary outcome measures

Invasive breast cancer-free survival (IBCFS) [Time frame: Up to 14 years]

Secondary outcome measures (7)

Invasive disease-free survival (IDFS) [Time frame: Up to 14 years]
Distant relapse-free survival (DRFS) [Time frame: Up to 14 years]
Overall survival (OS) [Time frame: 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) [Time frame: Until 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. [Time frame: Until 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-311 [Time frame: Until 28 days after the final dose of study treatment (up to 7 years)]
Pharmacokinetics (PK) [Time frame: Until 6 months from treatment start]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment