RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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)

Quick Facts

Study Start:2024-08-01
Study Completion:2030-10-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06380751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
  2. * Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer
  3. * Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease
  4. * ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
  5. * FFPE tumour tissue from each participant
  6. * Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2
  7. * Adequate organ and marrow function
  1. * Participants with history of MDS/AML or with features suggestive of MDS/AML
  2. * Participants with any known predisposition to bleeding
  3. * Any history of persisting severe cytopenia
  4. * Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections
  5. * Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection
  6. * History of another primary malignancy
  7. * Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia
  8. * Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease
  9. * Evidence of active and uncontrolled hepatitis B and/or hepatitis C
  10. * Evidence of active and uncontrolled HIV infection
  11. * Active tuberculosis infection
  12. * Cardiac criteria, including history of arrythmia and cardiovascular disease
  13. * Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions
  14. * 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
  15. * 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
  16. * 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
  17. * Prior treatment within 28 days with blood product support or growth factor support
  18. * Any systemic concurrent anti-cancer treatment
  19. * Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:
  20. 1. Strong and moderate CYP3A4 inducers/inhibitors
  21. 2. Sensitive CYP2B6 substrates
  22. 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.
  23. * Concomitant use of drugs that are known to prolong QT and have a known risk of TdP
  24. * Systemic use of atropine
  25. * The following exclusion criteria apply to treatments administered for early breast cancer:
  26. 1. Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
  27. 2. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
  28. 3. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
  29. 4. Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Gilbert, Arizona, 85234
United States
Research Site
Glendale, California, 91206
United States
Research Site
Los Angeles, California, 90089
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Grand Junction, Colorado, 81501
United States
Research Site
Hollywood, Florida, 33021
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Orlando, Florida, 32806
United States
Research Site
Chicago, Illinois, 60611
United States
Research Site
Evanston, Illinois, 60201
United States
Research Site
Park Ridge, Illinois, 60068
United States
Research Site
Urbana, Illinois, 61801
United States
Research Site
Winfield, Illinois, 60190
United States
Research Site
Indianapolis, Indiana, 46227
United States
Research Site
Louisville, Kentucky, 40207
United States
Research Site
Silver Spring, Maryland, 20902
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Dearborn, Michigan, 48126
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Royal Oak, Michigan, 48073
United States
Research Site
Royal Oak, Michigan, 48073
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
Camden, New Jersey, 08103
United States
Research Site
New Brunswick, New Jersey, 08901
United States
Research Site
Bronx, New York, 10469
United States
Research Site
Brooklyn, New York, 11220
United States
Research Site
Mineola, New York, 11501
United States
Research Site
New Hyde Park, New York, 11042
United States
Research Site
New York, New York, 10016
United States
Research Site
New York, New York, 10028
United States
Research Site
New York, New York, 10065
United States
Research Site
Shirley, New York, 11967
United States
Research Site
Stony Brook, New York, 11790
United States
Research Site
Westbury, New York, 11590
United States
Research Site
Hershey, Pennsylvania, 17033
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Pittsburgh, Pennsylvania, 15215
United States
Research Site
West Columbia, South Carolina, 29169
United States
Research Site
Nashville, Tennessee, 37219
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Houston, Texas, 77054
United States
Research Site
Norfolk, Virginia, 23502
United States
Research Site
Tacoma, Washington, 98405
United States
Research Site
Morgantown, West Virginia, 26506
United States
Research Site
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2030-10-18

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2030-10-18

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Breast Cancer