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

Breast Cancer, Early Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952557
• Other study ID #: D8535C00001
• Secondary ID: 2023-504031-41-0
• Status: Recruiting
• Phase: Phase 3
• Start date: October 5, 2023
• Est. completion date: May 6, 2037

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5500
• Est. completion date: May 6, 2037
• Est. primary completion date: March 4, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer, Early Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Camizestrant
Camizestrant. Experimental. Administered orally
• Tamoxifen
Tamoxifen. Comparator. Administered orally
• Anastrozole
Anastrozole. Comparator. Administered orally
• Letrozole
Letrozole. Comparator. Administered orally
• Exemestane
Exemestane. Comparator. Administered orally
• Abemaciclib
Abemaciclib adjuvant treatment Administered orally

Locations

Country	Name	City	State
Argentina	Research Site	Caba
Argentina	Research Site	Capital Federal
Argentina	Research Site	Ciudad Autonoma de Buenos Aires
Argentina	Research Site	San Juan
Australia	Research Site	Bankstown
Australia	Research Site	Bowral
Australia	Research Site	Brighton
Australia	Research Site	Clayton
Australia	Research Site	Fitzroy
Australia	Research Site	Murdoch
Australia	Research Site	Richmond
Australia	Research Site	South Brisbane
Australia	Research Site	St Leonards
Australia	Research Site	Subiaco
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Klagenfurt
Austria	Research Site	Linz
Austria	Research Site	Salzburg
Austria	Research Site	St. Veit an der Glan
Austria	Research Site	Steyr
Austria	Research Site	Wels
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Anderlecht
Belgium	Research Site	Brasschaat
Belgium	Research Site	Bruxelles
Belgium	Research Site	Charleroi
Belgium	Research Site	Edegem
Belgium	Research Site	Leuven
Belgium	Research Site	Namur
Belgium	Research Site	Wilrijk
Brazil	Research Site	Alfenas
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Blumenau
Brazil	Research Site	Curitiba
Brazil	Research Site	Fortaleza
Brazil	Research Site	Goiânia
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Velho
Brazil	Research Site	Pouso Alegre
Brazil	Research Site	Ribeirão Preto
Brazil	Research Site	Rio De Janeiro
Brazil	Research Site	Salvador
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Brazil	Research Site	Vitória
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Bulgaria	Research Site	Plovdiv
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Bulgaria	Research Site	Sofia
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Canada	Research Site	Barrie	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	Edmonton	Alberta
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Canada	Research Site	Kingston	Ontario
Canada	Research Site	Levis	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	North Vancouver	British Columbia
Canada	Research Site	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Sault Ste. Marie	Ontario
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Thunder Bay	Ontario
Canada	Research Site	Windsor	Ontario
Chile	Research Site	Providencia
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Korea, Republic of	Research Site	Cheonan-si
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Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Malaysia	Research Site	Johor Bahru
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New Zealand	Research Site	Palmerston North
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Peru	Research Site	Lima
Peru	Research Site	Lima
Philippines	Research Site	Bacolod
Philippines	Research Site	Iloilo City
Philippines	Research Site	Quezon
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Romania	Research Site	Iasi
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Romania	Research Site	Pitesti
Romania	Research Site	Sibiu
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Saudi Arabia	Research Site	Riyadh/MENA
Serbia	Research Site	Belgrade
Serbia	Research Site	Beograd
Serbia	Research Site	Nis
Serbia	Research Site	Novi Sad
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South Africa	Research Site	Johannesburg
Spain	Research Site	A Coruña
Spain	Research Site	Albacete
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Spain	Research Site	Barcelona
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Spain	Research Site	Cordoba
Spain	Research Site	El Palmar
Spain	Research Site	Elche(Alicante)
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Spain	Research Site	Granada
Spain	Research Site	La Coruña
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Malaga
Spain	Research Site	Manresa
Spain	Research Site	Murcia
Spain	Research Site	Palma de Mallorca
Spain	Research Site	San Sebastian
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Spain	Research Site	Zaragoza
Switzerland	Research Site	Basel
Switzerland	Research Site	Bellinzona
Switzerland	Research Site	Chur
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Taiwan	Research Site	Hsinchu
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Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Yong Kang City
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Hat Yai
Thailand	Research Site	Khon Kaen
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Cigli
Turkey	Research Site	Edirne
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
United Arab Emirates	Research Site	Abu Dhabi
United Arab Emirates	Research Site	Al Ain
United Arab Emirates	Research Site	Dubai
United Arab Emirates	Research Site	Dubai
United Kingdom	Research Site	Aberdeen
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United Kingdom	Research Site	Brighton
United Kingdom	Research Site	Guilford
United Kingdom	Research Site	Lancaster
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Leicester
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United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
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United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Stockton
United Kingdom	Research Site	Sutton In Ashfield
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United Kingdom	Research Site	Warwick
United Kingdom	Research Site	Whitchurch
United States	Research Site	Annapolis	Maryland
United States	Research Site	Appleton	Wisconsin
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Austin	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bedford	Texas
United States	Research Site	Bethesda	Maryland
United States	Research Site	Blue Ash	Ohio
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boston	Massachusetts
United States	Research Site	Charleston	West Virginia
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Des Moines	Iowa
United States	Research Site	Duarte	California
United States	Research Site	Durham	North Carolina
United States	Research Site	East Syracuse	New York
United States	Research Site	El Paso	Texas
United States	Research Site	Elmhurst	Illinois
United States	Research Site	Fairfax	Virginia
United States	Research Site	Fairway	Kansas
United States	Research Site	Farmington	New Mexico
United States	Research Site	Fayetteville	Arkansas
United States	Research Site	Flower Mound	Texas
United States	Research Site	Fort Myers	Florida
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United States	Research Site	Minneapolis	Minnesota
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United States	Research Site	Morgantown	West Virginia
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United States	Research Site	Nashville	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Brunswick	New Jersey
United States	Research Site	New Hyde Park	New York
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Newark	Delaware
United States	Research Site	Norfolk	Virginia
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orlando	Florida
United States	Research Site	Park Ridge	Illinois
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pinehurst	North Carolina
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plainfield	Illinois
United States	Research Site	Plano	Texas
United States	Research Site	Plantation	Florida
United States	Research Site	Plantation	Florida
United States	Research Site	Puyallup	Washington
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	Roanoke	Virginia
United States	Research Site	Rock Hill	South Carolina
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Savannah	Georgia
United States	Research Site	Sayre	Pennsylvania
United States	Research Site	Scarborough	Maine
United States	Research Site	Sioux Falls	South Dakota
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Spokane	Washington
United States	Research Site	Tallahassee	Florida
United States	Research Site	Thomasville	Georgia
United States	Research Site	Toledo	Ohio
United States	Research Site	Towson	Maryland
United States	Research Site	Tyler	Texas
United States	Research Site	Urbana	Illinois
United States	Research Site	Vancouver	Washington
United States	Research Site	Walnut Creek	California
United States	Research Site	West Hollywood	California
United States	Research Site	West Palm Beach	Florida
United States	Research Site	White Plains	New York
United States	Research Site	Winchester	Virginia
United States	Research Site	Worcester	Massachusetts
United States	Research Site	York	Pennsylvania
United States	Research Site	Youngstown	Ohio
United States	Research Site	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Austrian Breast and Colorectal Cancer Study Group (ABCSG)

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Estonia,  France,  Georgia,  Germany,  Greece,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  New Zealand,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Saudi Arabia,  Serbia,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive breast cancer-free survival (IBCFS)	IBCFS is defined as time from randomisation until date of first occurrence of: Invasive ipsilateral breast tumour recurrence; Locoregional invasive breast cancer recurrence; Distant recurrence; Contralateral invasive breast cancer; Death attributable to any cause.	Up to 14 years
Secondary	Invasive disease-free survival (IDFS)	IDFS is defined as time from randomisation until date of first occurrence of one of the following events: Invasive ipsilateral breast tumor recurrence; Locoregional invasive breast cancer recurrence; Distant recurrence; Contralateral invasive breast cancer; Second primary non-breast invasive cancer; Death attributable to any cause.	Up to 14 years
Secondary	Distant relapse-free survival (DRFS)	DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.	Up to 14 years
Secondary	Overall survival (OS)	OS is defined as time from randomisation until death from any cause.	Up to 14 years
Secondary	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)		Until 28 days after the final dose of study treatment (up to 7 years)
Secondary	Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.		Until 28 days after the final dose of study treatment (up to 7 years)
Secondary	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		Until 28 days after the final dose of study treatment (up to 7 years)
Secondary	Pharmacokinetics (PK)	Plasma concentrations of camizestrant pre-dose (trough concentration)	Until 6 months from treatment start