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
- Research Site · Gilbert, AZ 85234More trials in Gilbert
CA
- Research Site · Fountain Valley, CA 92708More trials in Fountain Valley
- Research Site · Glendale, CA 91206More trials in Glendale
- Research Site · Los Angeles, CA 90089More trials in Los Angeles
- Research Site · Newport Beach, CA 92663More trials in Newport Beach
CO
- Research Site · Aurora, CO 80045More trials in Aurora
- Research Site · Grand Junction, CO 81501More trials in Grand Junction
FL
- Research Site · Hollywood, FL 33021More trials in Hollywood
- Research Site · Jacksonville, FL 32224More trials in Jacksonville
- Research Site · Orlando, FL 32806More trials in Orlando
- Research Site · Orlando, FL 32806More trials in Orlando
IL
- Research Site · Arlington Heights, IL 60005More trials in Arlington Heights
- Research Site · Chicago, IL 60611More trials in Chicago
- Research Site · Evanston, IL 60201More trials in Evanston
- Research Site · Park Ridge, IL 60068More trials in Park Ridge
- Research Site · Schaumburg, IL 60173More trials in Schaumburg
- Research Site · Urbana, IL 61801More trials in Urbana
- Research Site · Winfield, IL 60190More trials in Winfield
IN
- Research Site · Indianapolis, IN 46227More trials in Indianapolis
KY
- Research Site · Louisville, KY 40207More trials in Louisville
MA
- Research Site · Boston, MA 02215More trials in Boston
MD
- Research Site · Baltimore, MD 21201More trials in Baltimore
- Research Site · Silver Spring, MD 20902More trials in Silver Spring
- Research Site · Silver Spring, MD 20904More trials in Silver Spring
MI
- Research Site · Dearborn, MI 48126More trials in Dearborn
- Research Site · Detroit, MI 48202More trials in Detroit
- Research Site · Royal Oak, MI 48073More trials in Royal Oak
- Research Site · Royal Oak, MI 48073More trials in Royal Oak
MN
- Research Site · Rochester, MN 55905More trials in Rochester
MO
- Research Site · Saint Joseph, MO 64507More trials in Saint Joseph
- Research Site · Springfield, MO 65804More trials in Springfield
- Research Site · St Louis, MO 63110More trials in St Louis
NJ
- Research Site · Camden, NJ 08103More trials in Camden
- Research Site · New Brunswick, NJ 08901More trials in New Brunswick
NY
- Research Site · Brooklyn, NY 11220More trials in Brooklyn
- Research Site · Mineola, NY 11501More trials in Mineola
- Research Site · New Hyde Park, NY 11042More trials in New Hyde Park
- Research Site · New York, NY 10016More trials in New York
- Research Site · New York, NY 10028More trials in New York
- Research Site · New York, NY 10065More trials in New York
- Research Site · Shirley, NY 11967More trials in Shirley
- Research Site · Stony Brook, NY 11790More trials in Stony Brook
- Research Site · The Bronx, NY 10469More trials in The Bronx
- Research Site · Westbury, NY 11590More trials in Westbury
PA
- Research Site · Hershey, PA 17033More trials in Hershey
- Research Site · Philadelphia, PA 19104More trials in Philadelphia
- Research Site · Pittsburgh, PA 15212More trials in Pittsburgh
- Research Site · Pittsburgh, PA 15215More trials in Pittsburgh
SC
- Research Site · West Columbia, SC 29169More trials in West Columbia
TN
- Research Site · Chattanooga, TN 37404More trials in Chattanooga
- Research Site · Nashville, TN 37203More trials in Nashville
TX
- Research Site · Houston, TX 77030More trials in Houston
- Research Site · Houston, TX 77030More trials in Houston
- Research Site · Houston, TX 77054More trials in Houston
- Research Site · San Antonio, TX 78240More trials in San Antonio
VA
- Research Site · Norfolk, VA 23502More trials in Norfolk
- Research Site · Richmond, VA 23226More trials in Richmond
WA
- Research Site · Tacoma, WA 98405More trials in Tacoma
WI
- Research Site · Milwaukee, WI 53215More trials in Milwaukee
WV
- Research Site · Morgantown, WV 26506More trials in Morgantown