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Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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

ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saruparib (AZD5305)

    Drug

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

  • Camizestrant

    Drug

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

  • Abemaciclib

    Drug

    CDK4/6 Inhibitor

  • Ribociclib

    Drug

    CDK4/6 Inhibitor

  • Palbociclib

    Drug

    CDK 4/6 Inhibitor

  • Fulvestrant

    Drug

    Endocrine Therapy

  • Letrozole

    Drug

    Endorcine Therapy

  • Anastrozole

    Drug

    Endocrine Therapy

  • Exemestane

    Drug

    Endocrine Therapy

Treatment groups

788 Participants
are divided into 4 treatment groups
Group A: Arm 1: saruparib (AZD5305) plus camizestrantExperimental treatment 2 interventions
Group B: Arm 2: Physician's choice CDK4/6i plus physician's choice ETActive comparator 7 interventions
Group C: Arm 3: Physician's choice CDK4/6i plus camizestrantExperimental treatment 4 interventions
Group D: Arm 4: Saruparib (AZD5305) plus physician's choice ETExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (Arm 1 vs arm 2)

PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.

Time frame
Up to approximately 64 months

Secondary outcomes

1

Progression-Free Survival (arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)

PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.

Time frame
Up to approximately 64 months
2

Overall Survival (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)

OS is defined as the time from randomisation until the date of death due to any cause.

Time frame
Up to approximately 88 months
3

Progression Free Survival 2 (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)

PFS2 is defined as the time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.

Time frame
Up to approximately 64 months
4

Time to chemotherapy (arm 1 vs 2, arm 4 vs 2, arm 1 vs 3, arm 3 vs 2, arm 4 vs 1)

Time to chemotherapy is defined as time from randomisation until the start date of the first subsequent chemotherapy treatment after discontinuation of randomised treatment (censoring participants who died prior to initiation of chemotherapy).

Time frame
Up to approximately 64 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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