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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06380751




Registration number
NCT06380751
Ethics application status
Date submitted
25/03/2024
Date registered
24/04/2024

Titles & IDs
Public title
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
Scientific title
A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)
Secondary ID [1] 0 0
D9722C00001
Universal Trial Number (UTN)
Trial acronym
EvoPAR-BR01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced 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 - Saruparib (AZD5305)
Treatment: Drugs - Camizestrant
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Ribociclib
Treatment: Drugs - Palbociclib
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Letrozole
Treatment: Drugs - Anastrozole
Treatment: Drugs - Exemestane

Experimental: Arm 1: saruparib (AZD5305) plus camizestrant - participants will receive saruparib (AZD5305) orally and camizestrant orally

Active comparator: Arm 2: Physician's choice CDK4/6i plus physician's choice ET - agents are indicated below and should follow local guidelines:

* Physician's Choice CDK4/6i:

* abemaciclib orally, or
* ribociclib orally, or
* palbociclib orally.
* Physician's Choice ET:

* fulvestrant intramuscularly, or
* One of the following AIs:

* letrozole orally, or
* anastrozole orally, or
* exemestane orally

Experimental: Arm 3: Physician's choice CDK4/6i plus camizestrant - participants will receive camizestrant orally. Agents for CDK4/6i treatment are indicated above and should follow local guidelines


Treatment: Drugs: Saruparib (AZD5305)
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on PARP2.

Treatment: Drugs: Camizestrant
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical and clinical activity in both ESR1 mutant and wild type settings .

Treatment: Drugs: Abemaciclib
CDK4/6 Inhibitor

Treatment: Drugs: Ribociclib
CDK4/6 Inhibitor

Treatment: Drugs: Palbociclib
CDK 4/6 Inhibitor

Treatment: Drugs: Fulvestrant
Endocrine Therapy

Treatment: Drugs: Letrozole
Endorcine Therapy

Treatment: Drugs: Anastrozole
Endocrine Therapy

Treatment: Drugs: Exemestane
Endocrine Therapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival
Timepoint [1] 0 0
Up to approximately 59 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to approximately 88 months
Secondary outcome [2] 0 0
Progression Free Survival 2
Timepoint [2] 0 0
Up to approximately 59 months
Secondary outcome [3] 0 0
Time to chemotherapy
Timepoint [3] 0 0
Up to approximately 59 months
Secondary outcome [4] 0 0
Objective Response Rate
Timepoint [4] 0 0
Up to approximately 59 months
Secondary outcome [5] 0 0
Duration of Response
Timepoint [5] 0 0
Up to approximately 59 months
Secondary outcome [6] 0 0
Participant-reported tolerability
Timepoint [6] 0 0
Up to approximately 59 months
Secondary outcome [7] 0 0
Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)
Timepoint [7] 0 0
Up to approximately 59 months
Secondary outcome [8] 0 0
Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)
Timepoint [8] 0 0
Up to approximately 59 months
Secondary outcome [9] 0 0
Plasma concentrations of saruparib (AZD5305)
Timepoint [9] 0 0
Up to approximately 59 months
Secondary outcome [10] 0 0
Plasma concentrations of camizestrant
Timepoint [10] 0 0
Up to approximately 59 months
Secondary outcome [11] 0 0
Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study.
Timepoint [11] 0 0
Up to approximately 59 months

Eligibility
Key inclusion criteria
* Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
* Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
* Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease
* ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
* FFPE tumour tissue from each participant
* Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2
* Adequate organ and marrow function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with history of MDS/AML or with features suggestive of MDS/AML
* Participants with any known predisposition to bleeding
* Any history of persisting severe cytopenia
* Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
* Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection
* History of another primary malignancy
* Persistent toxicities (CTCAE Grade = 2) caused by previous anti-cancer therapy excluding alopecia
* Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease
* Evidence of active and uncontrolled hepatitis B and/or hepatitis C
* Evidence of active and uncontrolled HIV infection
* Active tuberculosis infection
* Cardiac criteria, including history of arrythmia and cardiovascular disease
* Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study
* Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment
* Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET up to 28 days before randomisation
* Prior treatment within 28 days with blood product support or growth factor support
* Any systemic concurrent anti-cancer treatment
* Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:

1. Strong and moderate CYP3A4 inducers/inhibitors
2. Sensitive CYP2B6 substrates
3. Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.
* Concomitant use of drugs that are known to prolong QT and have a known risk of TdP
* Systemic use of atropine
* The following exclusion criteria apply to treatments administered for early breast cancer:

1. Disease progression = 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
2. Disease progression = 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
3. Disease progression = 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
4. Disease progression = 1 year (365 days) from the last dose of an oral SERD including camizestrant.

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
1/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/10/2030
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Malvern
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2139 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
VIC 3000 - Melbourne
Recruitment outside Australia
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Country [193] 0 0
Turkey
State/province [193] 0 0
Altindag-Ankara
Country [194] 0 0
Turkey
State/province [194] 0 0
Istanbul
Country [195] 0 0
Turkey
State/province [195] 0 0
Kayseri
Country [196] 0 0
Turkey
State/province [196] 0 0
Çankaya
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Cambridge
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Guildford
Country [199] 0 0
United Kingdom
State/province [199] 0 0
London
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Manchester
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Oxford
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Taunton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06380751