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Clinical Trials List

Protocol NumberRLY-2608-102
Not yet recruiting

2025-09-01 - 2031-06-30

Phase III

Recruiting6

ICD-10C50.011

Malignant neoplasm of nipple and areola, right female breast

ICD-10C50.012

Malignant neoplasm of nipple and areola, left female breast

ICD-10C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.0

Malignant neoplasm of female breast, nipple and areola

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)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    AstraZeneca AB,

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator YEN-SHEN LU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Chiang Hung Division of General Surgery
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Chang Lin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉建廷 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSU-YI CHAO
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

BRCA1, BRCA2 or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

Objectives

To demonstrate the superiority of saruparib (AZD5305) + camizestrant relative to physician’s choice CDK4/6i + ET, by assessment of PFS.

Test Drug

injective
tablet

Active Ingredient

Capivasertib
RLY-2608
Fulvestrant

Dosage Form

116
130
230
116

Dosage

200mg
100 mg
250 mg
160 mg

Endpoints

PFS is defined as time from randomisation until progression per RECIST v1.1 as assessed by BICR, or death due to any cause.
The analysis will include all randomised participants. All events will be included regardless of whether the participant withdraws from therapy, receives another anti-cancer therapy, or clinically progresses prior to RECIST v1.1 progression.
However, if the participant progresses or dies immediately after two or more consecutive missed visits, the participant will be censored at the time of the latest evaluable assessment prior to the two missed visits.
The measure of interest is the hazard ratio of PFS.

Inclution Criteria

1 Participants must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in
which the study is taking place) at the time of signing the ICF.
2 Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
(a) Pre/peri-menopausal women (ie, those who do not meet the criteria for
post-menopausal defined below) can be enrolled if amenable to treatment with an
LHRH agonist. Participants are to have commenced concomitant treatment with an
LHRH agonist prior to or on Cycle 1 Day 1 and must be willing to continue on it for
the duration of the study.
(b) Post-menopausal women are defined as:
(i) aged ≥ 60 years of age, OR
(ii) aged < 60 years of age and amenorrhoeic for at least 12 months following
cessation of all exogenous hormonal treatments/chemotherapy/ovarian
suppression/tamoxifen or similar. These participants should also have serum
oestradiol and FSH levels confirmed as being within the standard laboratory
reference range for post-menopausal females, OR
(iii) documented bilateral oophorectomy.
(c) Male participants can be enrolled if amenable to be treated with an LHRH agonist
unless the participants have clear orchiectomy medical history. Participants are to
have commenced concomitant treatment with an LHRH agonist prior to or on
Cycle 1 Day 1 and must be willing to continue on it for the duration of the study.

Exclusion Criteria

1 Participants with history of MDS/AML or with features suggestive of MDS/AML (as
determined by prior diagnostic investigation). Specific screening for MDS/AML is not
required.
2 Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent
[within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
3 Any history of persisting (> 2 weeks) severe cytopenia due to any cause (eg, absolute
neutrophil count < 0.5 × 109/L or platelets < 50 × 109/L).
4 As judged by the investigator, any evidence of severe or uncontrolled systemic diseases or
active uncontrolled infections, including but not limited to, uncontrolled major seizure
disorder and active bleeding diseases, unstable spinal cord compression, superior vena
cava syndrome, extensive interstitial bilateral lung disease, history of allogenic organ
transplant, which, in the investigator’s opinion, makes it undesirable for the participant to
participate in the study or that would jeopardise compliance with the protocol.
5 Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated
product, or previous significant bowel resection that would preclude adequate absorption,
distribution, metabolism, or excretion of the study medicine.

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    540 participants

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