RecruitingPhase 3

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

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests saruparib plus camizestrant against a doctor's choice of a CDK4/6 inhibitor plus hormone therapy. It is for adults with advanced breast cancer that is hormone receptor-positive (HR-positive), HER2-negative, and has a change in the BRCA1, BRCA2, or PALB2 gene.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adult women, whether or not they have gone through menopause, and adult men.
  • Breast cancer confirmed by a tissue or cell test. It must be HR-positive (uses hormones to grow) and HER2-negative.
  • Cancer has spread nearby and cannot be treated to cure it, or has spread to distant parts of the body.
  • Able to do all usual activities or most light activities, with no decline in the past 2 weeks.
  • Able to provide a preserved tumor tissue sample.
  • A confirmed inherited change in BRCA1, BRCA2, or PALB2 that stops the gene from working properly.
  • Organs and bone marrow, which makes blood cells, must work well enough.

Who can't join

  • Past or suspected MDS or AML (bone marrow or blood cancers), a known bleeding risk, or lasting, very low blood cell counts.
  • Severe or uncontrolled illness or infection, including uncontrolled hepatitis B, hepatitis C, or HIV; active tuberculosis; or certain heart problems.
  • Hard-to-control nausea or vomiting, long-term gut disease, trouble swallowing the study drug, or major past bowel removal.
  • Another past cancer; lasting moderate or worse side effects from cancer treatment, except hair loss; or cancer affecting the brain, spinal cord, or their lining.
  • Major surgery or serious injury within 4 weeks, planned major surgery during the study, or recent radiation for symptom relief within 2–4 weeks, depending on the area treated.
  • Prior whole-body cancer treatment for cancer that returned nearby or spread, except hormone therapy for up to 28 days before study assignment; current whole-body cancer treatment; or blood products or blood-cell growth support within 28 days.
  • Use of certain medicines or herbs that affect drug processing or heart rhythm, certain hormone treatments for non-cancer conditions, or atropine that acts throughout the body.
  • Cancer worsened within 84 days after chemotherapy for early breast cancer, or within 1 year after a PARP inhibitor, platinum drug, CDK4/6 inhibitor, or oral SERD such as camizestrant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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 for up to 28 days total 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 sites (60)

AZ

CA

CO

FL

IL

IN

KY

MA

MD

MI

MN

MO

NJ

NY

PA

SC

TN

TX

VA

WA

WI

WV