Clinical trial NCT05952557: An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
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
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
Collaborators: name: Austrian Breast and Colorectal Cancer Study Group (ABCSG)
First posted: 2023-07-19
Enrollment: 5500
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: Standard ET of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib • Arm B: Camizestrant ± abemaciclib
Primary purpose: TREATMENT

Brief summary: 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 within the study will be 7 years.

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.

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.

Primary outcomes:
measure: Invasive breast cancer-free survival (IBCFS)
timeFrame: Up to 14 years
Secondary outcomes:
measure: Invasive disease-free survival (IDFS)
timeFrame: Up to 14 years
measure: Distant relapse-free survival (DRFS)
timeFrame: Up to 14 years
measure: Overall survival (OS)
timeFrame: Up to 14 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 7 years)
measure: Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.
timeFrame: Until 28 days after the final dose of study treatment (up to 7 years)
measure: 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
timeFrame: Until 28 days after the final dose of study treatment (up to 7 years)
measure: Pharmacokinetics (PK)
timeFrame: Until 6 months from treatment start
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Phoenix
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city: Buenos Aires
country: Argentina
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country: Argentina
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country: Australia
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country: Austria
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country: Austria
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country: Austria
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country: Chile
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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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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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country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Yong Kang City
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Cigli
country: Turkey
facility: Research Site
city: Edirne
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: İstanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Karsiyaka
country: Turkey
facility: Research Site
city: Malatya
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Çankaya
country: Turkey
facility: Research Site
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
city: Al Ain
country: United Arab Emirates
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Brighton
country: United Kingdom
facility: Research Site
city: Burton-on-Trent
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Derby
country: United Kingdom
facility: Research Site
city: Guilford
country: United Kingdom
facility: Research Site
city: Ipswich
country: United Kingdom
facility: Research Site
city: Lancaster
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northampton
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Shrewsbury
country: United Kingdom
facility: Research Site
city: Stockton
country: United Kingdom
facility: Research Site
city: Sutton In Ashfield
country: United Kingdom
facility: Research Site
city: Sutton
country: United Kingdom
facility: Research Site
city: Taunton
country: United Kingdom
facility: Research Site
city: Warwick
country: United Kingdom
facility: Research Site
city: Whitchurch
country: United Kingdom
facility: Research Site
Study officials:
References: