Printed from Voxsanity (voxsanity.com.au) — NCT06556862 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT06556862
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are willing to take part voluntarily and sign a consent form.
- People aged 18 years or older.
- People with a general health and activity level rated between 0 and 2 on a standard medical scale (ECOG performance status), meaning they are fully active to capable of limited self-care (confirm with trial site).
- People with an expected survival of at least 6 months.
- People with breast cancer that has come back in the local area or spread to other parts of the body, confirmed by tissue or cell testing to be hormone receptor-positive (ER+ and/or PR+ at 10% or more) and HER2-negative, and that cannot be fully removed by surgery or treated with radiation therapy.
- People who have previously received cancer treatment meeting all of the following: no more than 1 line of chemotherapy for returned or spread breast cancer; disease that came back or spread during or after treatment with Palbociclib, Abemaciclib, or Ribociclib (whether given before surgery, after surgery, or for metastatic disease); and no more than 3 lines of hormone therapy for returned or spread breast cancer.
- People who have at least one measurable area of cancer outside the brain, as defined by standard imaging criteria (RECIST v1.1).
- People whose major organ functions meet the required levels as assessed by the trial site.
- People with a white blood cell count (neutrophils) of at least 1.5 × 10⁹/L.
- People with a platelet count of at least 90 × 10⁹/L.
- People with a haemoglobin level of at least 90 g/L.
- People with a total bilirubin level (a marker of liver function) no higher than 1.5 times the upper limit of normal.
- People with liver enzyme levels (ALT and AST) no higher than 2.5 times the upper limit of normal.
- People with kidney function markers (BUN and creatinine) no higher than 1.5 times the upper limit of normal.
- People with a heart pumping function (left ventricular ejection fraction) of at least 50%.
- People with a heart rhythm measurement (QTcF) of less than 470 milliseconds, and blood clotting markers (INR and APTT) within 1.5 times the upper limit of normal.
- People who have recovered from any side effects of previous cancer treatment to a mild level (Grade 1 or lower) before starting the study drug.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have previously been treated with a type of drug called a histone deacetylase inhibitor (HDACi).
- People who have previously received the drug Dalpiciclib.
- People whose cancer has spread to the membranes surrounding the brain or spinal cord, confirmed by MRI or lumbar puncture (spinal tap).
- People with cancer spread to the brain confirmed by imaging, unless they have asymptomatic brain metastases not requiring immediate treatment, or previously treated brain metastases that have been stable for at least 4 weeks with no need for symptom-relieving medications for more than 2 weeks (confirm with trial site).
- People experiencing a severe and rapidly worsening spread of cancer to vital organs (such as the lungs' lymph vessels, bone marrow, brain/spinal cord lining, or widespread liver spread with abnormal liver function) that makes hormone therapy unsuitable.
- People who had fluid build-up in the abdomen, around the lungs, or around the heart causing symptoms, and who needed the fluid drained within 4 weeks before starting the study drug.
- People who are unable to swallow, have a bowel obstruction, or have any other condition that would prevent them from taking or absorbing the study medication.
- People diagnosed with any other cancer in the 5 years before joining the study, except for certain skin cancers or early-stage cervical or thyroid cancers that have been fully treated (confirm with trial site for specific exceptions).
- People who have had major surgery or a major physical injury within 4 weeks before starting treatment, or who are expected to need major surgery during the study.
- People with a known allergy to any ingredient in the study drugs.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Principal Investigator: Tao Wang, Beijing 302 Hospital
Phone: +86-010-66947250
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Beijing 302 Hospital
Registry
ClinicalTrials.gov
Start date
1 October 2025
Est. completion
31 December 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
PFS
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.