Clinical trial NCT05774951: A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer, Early Breast Cancer
Keywords: ER+
HER2-
breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-03-20
Enrollment: 4300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomised in a 1:1 ratio to one of the following arms:

* Arm A: Continue standard ET of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen)
* Arm B: Camizestrant
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Invasive breast cancer-free survival (IBCFS)
timeFrame: Up to 10 years
Secondary outcomes:
measure: Invasive disease-free survival (IDFS)
timeFrame: Up to 10 years
measure: Distant relapse-free survival (DRFS)
timeFrame: Up to 10 years
measure: Overall survival (OS)
timeFrame: Up to 10 years
measure: 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)
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: Absolute and percent change from baseline in Clinical Laboratory Parameters
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: Absolute and percent change from baseline in Vital Sign Parameters
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: Number of participants with abnormal physical examinations
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: 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)
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: 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)
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: 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)
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: 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)
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: 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)
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: 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)
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL items from the EORTC-QLQ-C30 items 11 and 12. EORTC-QLQ-C30 uses 0 - 4 scale (higher score is worse)
timeFrame: Until 28 days after the final dose of study treatment (up to 5 years)
measure: Pharmacokinetics (PK)
timeFrame: Until 6 months from treatment start
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Dothan
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city: Winston-Salem
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city: Madison
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state: Wisconsin
city: Buenos Aires
country: Argentina
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country: Argentina
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city: Caba
country: Argentina
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city: Capital Federal
country: Argentina
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city: Ciudad Autonoma de Buenos Aires
country: Argentina
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city: Ciudad Autónoma Buenos Aires
country: Argentina
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country: Argentina
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city: Cordoba
country: Argentina
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city: Cordoba
country: Argentina
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country: Argentina
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city: Mar del Plata
country: Argentina
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city: Salta
country: Argentina
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country: Argentina
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country: Argentina
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city: San Miguel de Tucumán
country: Argentina
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country: Argentina
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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city: Nedlands
country: Australia
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city: Randwick
country: Australia
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country: Australia
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country: Australia
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city: Wendouree
country: Australia
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city: Graz
country: Austria
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city: Innsbruck
country: Austria
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city: Klagenfurt
country: Austria
facility: Research Site
city: Kufstein
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Ried
country: Austria
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city: St. Veit an der Glan
country: Austria
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country: Austria
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city: Vienna
country: Austria
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city: Voecklabruck
country: Austria
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city: Wels
country: Austria
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city: Wien
country: Austria
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city: Wien
country: Austria
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city: Brasschaat
country: Belgium
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city: Brussel
country: Belgium
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city: Edegem
country: Belgium
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city: Gent
country: Belgium
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city: Leuven
country: Belgium
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country: Belgium
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country: Belgium
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city: Ottignies
country: Belgium
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city: Wilrijk
country: Belgium
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country: Belgium
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city: Alfenas
country: Brazil
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city: Barretos
country: Brazil
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city: Belo Horizonte
country: Brazil
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city: Belo Horizonte
country: Brazil
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city: Brasilia
country: Brazil
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city: Brasilia
country: Brazil
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city: Chapeco
country: Brazil
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city: Cuiabá
country: Brazil
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city: Curitiba
country: Brazil
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city: Curitiba
country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
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city: Londrina
country: Brazil
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city: Natal
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country: Brazil
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country: Brazil
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country: Brazil
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city: Porto Alegre
country: Brazil
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country: Brazil
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country: Brazil
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city: Porto Alegre
country: Brazil
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country: Brazil
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country: Brazil
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Canada
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country: Canada
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country: Canada
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country: Canada
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country: Chile
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country: Chile
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country: Chile
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country: Chile
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country: Chile
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country: Chile
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country: Chile
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country: Chile
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country: Chile
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city: Baoding
country: China
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city: Beijing
country: China
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city: Beijing
country: China
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city: Beijing
country: China
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country: China
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country: China
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country: China
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city: Changsha
country: China
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country: China
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city: Chengdu
country: China
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city: Chengdu
country: China
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city: Chifeng
country: China
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country: China
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city: Foshan
country: China
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city: Fuzhou
country: China
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city: Fuzhou
country: China
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city: Guangzhou Shi
country: China
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city: Guangzhou
country: China
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city: Guangzhou
country: China
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country: China
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city: Haikou
country: China
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country: China
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city: Hangzhou
country: China
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city: Hangzhou
country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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city: Huangpu District
country: China
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country: China
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city: Lanzhou
country: China
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city: Liuzhou
country: China
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city: Nanchang
country: China
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city: Nanjing
country: China
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city: Nanjing
country: China
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city: Nanning
country: China
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city: Nanning
country: China
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city: Neijiang
country: China
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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city: Sutton
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh city
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Hue
country: Vietnam
facility: Research Site
Study officials:
References: