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Compares treatment options for Advanced Breast Cancer
Official title 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
ClinicalTrials.gov ID: NCT06380751
What this study is testing
What is Saruparib (AZD5305)?
Saruparib (AZD5305) is an investigational medicine, being studied as a potential treatment for advanced breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 up to 28 days 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:
- Strong and moderate CYP3A4 inducers/inhibitors
- Sensitive CYP2B6 substrates
- 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:
- Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy
- Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer
- Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting
- Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Fountain Valley, California, United States
- Glendale, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Aurora, Colorado, United States
- Grand Junction, Colorado, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Evanston, Illinois, United States
- Park Ridge, Illinois, United States
- Urbana, Illinois, United States
- Winfield, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Silver Spring, Maryland, United States
- Boston, Massachusetts, United States
+ 235 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Fountain Valley, California, United States; Glendale, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Aurora, Colorado, United States and 249 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.