Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

5500

Study ID:

NCT05952557

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 452 Locations for this study

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Research Site
Fountain Valley California, 92708, United States
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Los Angeles California, 90017, United States
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Monterey California, 93940, United States
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Gainesville Florida, 32610, United States
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Plantation Florida, 33322, United States
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Plantation Florida, 33324, United States
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Atlanta Georgia, 30318, United States
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Columbus Georgia, 31904, United States
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Savannah Georgia, 31404, United States
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Thomasville Georgia, 31792, United States
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Fairway Kansas, 66205, United States
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New Orleans Louisiana, 70121, United States
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Baltimore Maryland, 21201, United States
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Bethesda Maryland, 20817, United States
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Towson Maryland, 21204, United States
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Boston Massachusetts, 02111, United States
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Hyannis Massachusetts, 02601, United States
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Worcester Massachusetts, 01655, United States
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Kansas City Missouri, 64111, United States
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New Brunswick New Jersey, 08901, United States
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Farmington New Mexico, 87401, United States
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New Hyde Park New York, 11042, United States
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White Plains New York, 10601, United States
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Youngstown Ohio, 44504, United States
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Sayre Pennsylvania, 18840, United States
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Greenville South Carolina, 29605, United States
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Rock Hill South Carolina, 29732, United States
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Sioux Falls South Dakota, 57105, United States
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Knoxville Tennessee, 37909, United States
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Knoxville Tennessee, 37920, United States
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Memphis Tennessee, 38120, United States
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Spokane Washington, 99202, United States
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Charleston West Virginia, 25304, United States
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Milwaukee Wisconsin, 53215, United States
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Caba , 1061, Argentina
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Brighton , 3186, Australia
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Wels , 4600, Austria
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Wilrijk , 2610, Belgium
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Porto Alegre , 90610, Brazil
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Varna , 9010, Bulgaria
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Calgary Alberta, T2N 4, Canada
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Edmonton Alberta, t6G1Z, Canada
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Kelowna British Columbia, V1Y 5, Canada
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North Vancouver British Columbia, V7L 2, Canada
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Halifax Nova Scotia, B3H 2, Canada
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Barrie Ontario, L4M 6, Canada
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Kingston Ontario, K7L 2, Canada
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Sudbury Ontario, P3E 5, Canada
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Thunder Bay Ontario, P7B 6, Canada
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Chicoutimi Quebec, G7H 5, Canada
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Levis Quebec, G6V 3, Canada
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Montreal Quebec, H1T 2, Canada
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Montreal Quebec, H4A 3, Canada
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Saskatoon Saskatchewan, S7N 4, Canada
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Quebec , G1S 4, Canada
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Temuco , 48102, Chile
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Fuzhou , 35001, China
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Valledupar , 20000, Colombia
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Zadar , 23000, Croatia
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Pardubice , 532 0, Czechia
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Tallinn , 11619, Estonia
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Strasbourg , 67033, France
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Tbilisi , 160, Georgia
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Saarbrücken , 66113, Germany
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Thessaloniki , 546 3, Greece
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Budapest , 1082, Hungary
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Budapest , 1122, Hungary
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Gyula , 5700, Hungary
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Győr , 9024, Hungary
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Kaposvár , 7400, Hungary
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Kecskemét , 6000, Hungary
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Miskolc , 3526, Hungary
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Nyíregyháza , 4400, Hungary
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Szekszárd , 7100, Hungary
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Zalaegerszeg , 8900, Hungary
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Mysuru , 57001, India
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Dublin , DO4YN, Ireland
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Kfar Saba , 49281, Israel
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Bologna , 40138, Italy
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Brindisi , 72100, Italy
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Firenze , 50134, Italy
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Genoa , 16132, Italy
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Milano , 20132, Italy
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Milan , 20141, Italy
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Misterbianco , 95045, Italy
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Modena , 41124, Italy
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Monza , 20900, Italy
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Napoli , 80131, Italy
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Novara , 28100, Italy
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Padova , 35128, Italy
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Roma , 00161, Italy
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Roma , 00168, Italy
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Rozzano , 20089, Italy
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Torino , 10126, Italy
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Trento , 38100, Italy
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Nagoya-shi , 467-0, Japan
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Cheonan-si , 31151, Korea, Republic of
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Daegu , 41404, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Seongnam-si , 13620, Korea, Republic of
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Seoul , 02841, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 06273, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Seoul , 5505, Korea, Republic of
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Kota Bharu , 16150, Malaysia
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Veracruz , 91851, Mexico
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Palmerston North , 4414, New Zealand
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Arequipa , AREQU, Peru
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Bacolod , 6100, Philippines
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Gdańsk , 80-95, Poland
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Lisboa , 1998-, Portugal
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Craiova , 20009, Romania
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Riyadh/MENA , 11426, Saudi Arabia
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Beograd , 11010, Serbia
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Johannesburg , 2193, South Africa
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San Sebastian , 20014, Spain
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Luzern , 6000, Switzerland
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Taipei , 11259, Taiwan
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Bangkok , 10210, Thailand
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Bangkok , 10330, Thailand
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Bangkok , 10400, Thailand
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Bangkok , 10700, Thailand
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Hat Yai , 90110, Thailand
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Khon Kaen , 40002, Thailand
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İstanbul , 34457, Turkey
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Dubai , 50500, United Arab Emirates
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Lancaster , LA1 4, United Kingdom
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Manchester , M20 4, United Kingdom
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Northampton , NN1 5, United Kingdom
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Stockton , TS19 , United Kingdom
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Sutton In Ashfield , NG17 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

5500

Study ID:

NCT05952557

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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