Recruiting NCT05774951

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

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 +34
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

Overview

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - 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. The planned duration of treatment in either arm of the study is 60 months.

Detailed description

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer 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. The planned duration of treatment in either arm of the study is 60 months. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. 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 per local approved label
Drug Anastrozole
Anastrozole. Comparator. Administered per local approved label
Drug Letrozole
Letrozole. Comparator. Administered per local approved label
Drug Exemestane
Exemestane. Comparator. Administered per local approved label

Primary outcome measures

Invasive breast cancer-free survival (IBCFS) [Time frame: Up to 10 years]

Secondary outcome measures (12)

Invasive disease-free survival (IDFS) [Time frame: Up to 10 years]
Distant relapse-free survival (DRFS) [Time frame: Up to 10 years]
Overall survival (OS) [Time frame: Up to 10 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 5 years)]
Absolute and percent change from baseline in Clinical Laboratory Parameters [Time frame: Until 28 days after the final dose of study treatment (up to 5 years)]
Absolute and percent change from baseline in Vital Sign Parameters [Time frame: Until 28 days after the final dose of study treatment (up to 5 years)]
Change from baseline of arthralgia as measured by the EORTC-IL-194 (European Organisation for Research and Treatment of Cancer) item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) [Time frame: Until 28 days after the final dose of study treatment (up to 5 years)]
Change from baseline of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) [Time frame: Until 28 days after the final dose of study treatment (up to 5 years)]
Change from baseline of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) [Time frame: Until 28 days after the final dose of study treatment (up to 5 years)]
Proportion of patients experiencing each level of symptomatic AEs of arthralgia as measured by the EORTC-IL-194 item 10. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) [Time frame: Until 28 days after the final dose of study treatment (up to 5 years)]
Proportion of patients experiencing each level of symptomatic AEs of hot flush as measured by the EORTC-IL-194 item 4. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) [Time frame: Until 28 days after the final dose of study treatment (up to 5 years)]
Proportion of patients experiencing each level of symptomatic AEs of vaginal dryness as measured by the EORTC-IL-194 item 15. EORTC-IL-194 uses 0 - 4 scale (higher score is worse) [Time frame: Until 28 days after the final dose of study treatment (up to 5 years)]

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 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 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 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 sex hormone therapy
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