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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05774951




Registration number
NCT05774951
Ethics application status
Date submitted
16/02/2023
Date registered
20/03/2023
Date last updated
19/04/2024

Titles & IDs
Public title
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Scientific title
A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer
Secondary ID [1] 0 0
2022-501024-20-00
Secondary ID [2] 0 0
D8531C00002
Universal Trial Number (UTN)
Trial acronym
CAMBRIA-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer, Early Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Camizestrant
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane

Active Comparator: Arm A: standard endocrine therapy of investigator´s choice - Continue standard endocrine therapy of investigator's choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen)

Experimental: Arm B: camizestrant - Camizestrant


Treatment: Drugs: Camizestrant
Camizestrant. Experimental. Administered orally

Treatment: Drugs: Tamoxifen
Tamoxifen. Comparator. Administered per local approved label

Treatment: Drugs: Anastrozole
Anastrozole. Comparator. Administered per local approved label

Treatment: Drugs: Letrozole
Letrozole. Comparator. Administered per local approved label

Treatment: Drugs: Exemestane
Exemestane. Comparator. Administered per local approved label
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive breast cancer-free survival (IBCFS)
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [1] 0 0
Invasive disease-free survival (IDFS)
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [2] 0 0
Distant relapse-free survival (DRFS)
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 10 years
Secondary outcome [4] 0 0
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)
Timepoint [4] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [5] 0 0
Absolute and percent change from baseline in Clinical Laboratory Parameters
Timepoint [5] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [6] 0 0
Absolute and percent change from baseline in Vital Sign Parameters
Timepoint [6] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [7] 0 0
Number of participants with abnormal physical examinations
Timepoint [7] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [9] 0 0
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)
Timepoint [9] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [10] 0 0
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)
Timepoint [10] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [11] 0 0
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)
Timepoint [11] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [13] 0 0
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)
Timepoint [13] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [14] 0 0
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)
Timepoint [14] 0 0
Until 28 days after the final dose of study treatment (up to 5 years)
Secondary outcome [15] 0 0
Pharmacokinetics (PK)
Timepoint [15] 0 0
Until 6 months from treatment start

Eligibility
Key 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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/05/2036
Actual
Sample size
Target
4300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Birtinya
Recruitment hospital [2] 0 0
Research Site - Brighton
Recruitment hospital [3] 0 0
Research Site - Concord
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - Randwick
Recruitment hospital [6] 0 0
Research Site - Tweed Heads
Recruitment hospital [7] 0 0
Research Site - Waratah
Recruitment hospital [8] 0 0
Research Site - Wendouree
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
3186 - Brighton
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [7] 0 0
2298 - Waratah
Recruitment postcode(s) [8] 0 0
3355 - Wendouree
Recruitment outside Australia
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United States of America
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Alabama
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Metz Cedex 03
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France
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France
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Nantes
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France
State/province [193] 0 0
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France
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Paris
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France
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Pierre Benite
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France
State/province [196] 0 0
Plerin SUR MER
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France
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Poitiers
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France
State/province [198] 0 0
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France
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Rennes
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France
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France
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France
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France
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Toulouse Cedex 09
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France
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Tours CEDEX
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France
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France
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Georgia
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Germany
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Germany
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Germany
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Germany
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Germany
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Bonn
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Germany
State/province [214] 0 0
Deggendorf
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Germany
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Dessau-Rosslau
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Germany
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Dresden
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Germany
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Düsseldorf
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Germany
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Germany
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Esslingen
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Germany
State/province [220] 0 0
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Germany
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Guetersloh
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Germany
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Landshut
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Germany
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Luebeck
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Germany
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Germany
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Germany
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München
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Germany
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Germany
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Rüsselsheim am Main
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Germany
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Germany
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Torgau
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Germany
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Trier
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Germany
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Ulm
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Germany
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Velbert
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Germany
State/province [237] 0 0
Wiesbaden
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Germany
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Worms
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Germany
State/province [239] 0 0
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Greece
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Athens
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Greece
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Chaidari
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Greece
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Heraklion
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Greece
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Ioannina
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Greece
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Rio
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Greece
State/province [245] 0 0
Thessaloniki
Country [246] 0 0
Hungary
State/province [246] 0 0
Budapest
Country [247] 0 0
Hungary
State/province [247] 0 0
Debrecen
Country [248] 0 0
Hungary
State/province [248] 0 0
Gyula
Country [249] 0 0
Hungary
State/province [249] 0 0
Gyor
Country [250] 0 0
Hungary
State/province [250] 0 0
Kaposvár
Country [251] 0 0
Hungary
State/province [251] 0 0
Miskolc
Country [252] 0 0
Hungary
State/province [252] 0 0
Nyíregyháza
Country [253] 0 0
Hungary
State/province [253] 0 0
Szekszárd
Country [254] 0 0
Hungary
State/province [254] 0 0
Szolnok
Country [255] 0 0
India
State/province [255] 0 0
Bangalore
Country [256] 0 0
India
State/province [256] 0 0
Belagavi
Country [257] 0 0
India
State/province [257] 0 0
Bhubaneswar
Country [258] 0 0
India
State/province [258] 0 0
Hubli
Country [259] 0 0
India
State/province [259] 0 0
Hyderabad
Country [260] 0 0
India
State/province [260] 0 0
Jaipur
Country [261] 0 0
India
State/province [261] 0 0
Kolkata
Country [262] 0 0
India
State/province [262] 0 0
Mumbai
Country [263] 0 0
India
State/province [263] 0 0
Nagpur
Country [264] 0 0
India
State/province [264] 0 0
Nashik
Country [265] 0 0
India
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New Delhi
Country [266] 0 0
India
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Pune
Country [267] 0 0
India
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Thane
Country [268] 0 0
India
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Visakhapatnam
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India
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West Bengal
Country [270] 0 0
Israel
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Israel
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Ashdod
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Israel
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Haifa
Country [273] 0 0
Israel
State/province [273] 0 0
Jerusalem
Country [274] 0 0
Israel
State/province [274] 0 0
Kfar-Saba
Country [275] 0 0
Israel
State/province [275] 0 0
Nahariya
Country [276] 0 0
Israel
State/province [276] 0 0
Ramat Gan
Country [277] 0 0
Israel
State/province [277] 0 0
Rehovot
Country [278] 0 0
Israel
State/province [278] 0 0
Tel Aviv
Country [279] 0 0
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State/province [279] 0 0
Bari
Country [280] 0 0
Italy
State/province [280] 0 0
Catania
Country [281] 0 0
Italy
State/province [281] 0 0
Catanzaro
Country [282] 0 0
Italy
State/province [282] 0 0
Firenze
Country [283] 0 0
Italy
State/province [283] 0 0
Genova
Country [284] 0 0
Italy
State/province [284] 0 0
Grosseto
Country [285] 0 0
Italy
State/province [285] 0 0
Milano
Country [286] 0 0
Italy
State/province [286] 0 0
Milan
Country [287] 0 0
Italy
State/province [287] 0 0
Modena
Country [288] 0 0
Italy
State/province [288] 0 0
Napoli
Country [289] 0 0
Italy
State/province [289] 0 0
Pisa
Country [290] 0 0
Italy
State/province [290] 0 0
Reggio Emilia
Country [291] 0 0
Italy
State/province [291] 0 0
Roma
Country [292] 0 0
Italy
State/province [292] 0 0
Rozzano
Country [293] 0 0
Italy
State/province [293] 0 0
Turin
Country [294] 0 0
Japan
State/province [294] 0 0
Chiba-shi
Country [295] 0 0
Japan
State/province [295] 0 0
Fukuoka-shi
Country [296] 0 0
Japan
State/province [296] 0 0
Fukushima-shi
Country [297] 0 0
Japan
State/province [297] 0 0
Hidaka-shi
Country [298] 0 0
Japan
State/province [298] 0 0
Hirakata-shi
Country [299] 0 0
Japan
State/province [299] 0 0
Hiroshima-shi
Country [300] 0 0
Japan
State/province [300] 0 0
Isehara-shi
Country [301] 0 0
Japan
State/province [301] 0 0
Kagoshima-shi
Country [302] 0 0
Japan
State/province [302] 0 0
Kashiwa
Country [303] 0 0
Japan
State/province [303] 0 0
Kitaadachi-gun
Country [304] 0 0
Japan
State/province [304] 0 0
Koto-ku
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Japan
State/province [305] 0 0
Kumamoto-shi
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Japan
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Kurume-shi
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Japan
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Kyoto-shi
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Japan
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Matsuyama-shi
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Japan
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Nagoya-shi
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Japan
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Niigata-shi
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Japan
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Japan
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Japan
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Sagamihara-shi
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Japan
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Sapporo
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Japan
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Sendai-shi
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Japan
State/province [316] 0 0
Suita-shi
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Japan
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Sunto-gun
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Japan
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Takasaki-shi
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Japan
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Japan
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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George Town
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Johor Bahru
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Kota Bharu
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Malaysia
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Kuching
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Melaka
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Mexico
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Mexico
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Alc. Cuauhtémoc
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Mexico
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Mexico
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Mexico City
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Geleen
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Groningen
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Hoofddorp
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Callao
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Peru
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La Libertad
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Peru
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Trujillo
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Bacolod
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Philippines
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Cebu
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Philippines
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Iloilo city
Country [359] 0 0
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Manila
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Philippines
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Quezon City
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Poland
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Poland
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Poland
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Lublin
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Poland
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Opole
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Poland
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Poland
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Poland
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Poland
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Warszawa
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Poland
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Wieliszew
Country [371] 0 0
Poland
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Lódz
Country [372] 0 0
Portugal
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Amadora
Country [373] 0 0
Portugal
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Braga
Country [374] 0 0
Portugal
State/province [374] 0 0
Guimarães
Country [375] 0 0
Portugal
State/province [375] 0 0
Lisboa
Country [376] 0 0
Portugal
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Matosinhos
Country [377] 0 0
Portugal
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Porto
Country [378] 0 0
Portugal
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Vila Nova de Gaia
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Romania
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Baia Mare
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Romania
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Brasov
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Romania
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Cluj Napoca
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Serbia
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Serbia
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Serbia
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Serbia
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South Africa
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George
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South Africa
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South Africa
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Pietermaritzburg
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South Africa
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Pretoria
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South Africa
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Spain
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Spain
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Spain
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Alcoy
Country [410] 0 0
Spain
State/province [410] 0 0
Alicant
Country [411] 0 0
Spain
State/province [411] 0 0
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Country [412] 0 0
Spain
State/province [412] 0 0
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Country [413] 0 0
Spain
State/province [413] 0 0
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Country [414] 0 0
Spain
State/province [414] 0 0
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Spain
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Barcelona
Country [416] 0 0
Spain
State/province [416] 0 0
Cáceres
Country [417] 0 0
Spain
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Elche(Alicante)
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Spain
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Galdakao
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Spain
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Gerona
Country [420] 0 0
Spain
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Granada
Country [421] 0 0
Spain
State/province [421] 0 0
Jerez De La Frontera (Cádiz)
Country [422] 0 0
Spain
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L'Hospitalet de Llobregat
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Spain
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Leganés
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Spain
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Lérida
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Spain
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Madrid
Country [426] 0 0
Spain
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Majadahonda
Country [427] 0 0
Spain
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Manresa
Country [428] 0 0
Spain
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Country [429] 0 0
Spain
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Spain
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Parla
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Spain
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Puerto De Sagunto
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Spain
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Spain
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Spain
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San Juan de Alicante
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Spain
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Spain
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Country [437] 0 0
Spain
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Country [438] 0 0
Spain
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Teruel
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Spain
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Toledo
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Spain
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Taiwan
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Taiwan
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Taichung
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Taiwan
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Taiwan
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Tainan
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Taiwan
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Taipei City
Country [447] 0 0
Taiwan
State/province [447] 0 0
Taipei
Country [448] 0 0
Thailand
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Bangkok
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Thailand
State/province [449] 0 0
Khon Kaen
Country [450] 0 0
Thailand
State/province [450] 0 0
Phisanulok
Country [451] 0 0
Thailand
State/province [451] 0 0
Phitsanulok
Country [452] 0 0
Thailand
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Rachathewi
Country [453] 0 0
Thailand
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Songkla
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Turkey
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Aydin
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Turkey
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Turkey
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Turkey
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Istambul
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Turkey
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Istanbul
Country [460] 0 0
Turkey
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Izmir
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Turkey
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Samsun
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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United Kingdom
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Country [472] 0 0
United Kingdom
State/province [472] 0 0
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Country [473] 0 0
United Kingdom
State/province [473] 0 0
Peterborough
Country [474] 0 0
United Kingdom
State/province [474] 0 0
Stoke on Trent
Country [475] 0 0
United Kingdom
State/province [475] 0 0
Sutton
Country [476] 0 0
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Hanoi
Country [477] 0 0
Vietnam
State/province [477] 0 0
Ho Chi Minh city
Country [478] 0 0
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Ho Chi Minh
Country [479] 0 0
Vietnam
State/province [479] 0 0
Hue

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05774951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
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Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
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Phone 0 0
1-877-240-9479
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Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05774951