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Breast Cancer Trial, Not Yet Recruiting
NCT06711094
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
- Women aged 18 to 75 who are postmenopausal (including those who have had both ovaries removed, are 60 or older, or are under 60 with confirmed postmenopausal hormone levels) or who are pre- or perimenopausal and willing to receive hormone-suppressing injections (LHRH agonist therapy) during the study.
- People with breast cancer confirmed by biopsy or tissue testing to have low levels of estrogen receptors (ER-positive in 1%–10% of cells) and to be HER2-negative, where the cancer has come back or spread to other parts of the body and cannot be treated with surgery or radiotherapy aimed at curing the disease.
- People who have not yet received any systemic (whole-body) anti-cancer treatment for their recurrent or metastatic breast cancer.
- People with a general health and activity score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physically demanding activities.
- People who have measurable areas of cancer, or bone metastases only (including certain types of bone lesions), that meet standard measurement criteria used in clinical trials (RECIST 1.1).
- People with adequate functioning of major organs and bone marrow, based on blood and other tests (confirm with trial site for specific thresholds).
- People of reproductive age who have a negative pregnancy blood test within 7 days before joining, and who are willing to use a highly effective form of contraception during the study and for 3 months after the last dose of study medication.
- People whose side effects from any previous anti-cancer treatment have resolved to a mild or absent level (grade 0–1), with the exception of certain lasting effects such as hair loss that the study doctor considers low risk.
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 whose breast cancer was previously confirmed by tissue testing to be HER2-positive.
- People with inflammatory breast cancer.
- People whose cancer got worse or came back during earlier preventive (adjuvant) treatment, or within 12 months of finishing that treatment.
- People who the study doctors consider unsuitable for chemotherapy, including those whose cancer has spread to internal organs and who may be at risk of serious, life-threatening complications in the short term (such as uncontrolled fluid build-up in the chest, heart lining, or abdomen, cancer spreading through the lung's lymph vessels, or more than 50% of the liver being affected).
- People with active brain or spinal cord lining (meningeal) metastases that are causing symptoms, confirmed by a brain CT or MRI scan.
- People who have previously been treated with any CDK4/6 inhibitor medication.
- People who have had major surgery, chemotherapy, radiation therapy, another experimental drug, or any other anti-cancer treatment within the 2 weeks before joining the study.
- People diagnosed with another cancer within the 3 years before joining the study, except for certain treated skin cancers (non-melanoma, basal cell, or squamous cell) or cervical carcinoma in situ that has been fully treated.
- People with HIV infection or AIDS, active hepatitis B (with virus levels above a specified threshold), active hepatitis C, or a combination of hepatitis B and C infection.
- People who, within the 6 months before joining the study, experienced a heart attack, severe or unstable chest pain (angina), moderate-to-severe heart failure, persistent significant irregular heartbeats, any grade of atrial fibrillation, heart bypass or artery bypass surgery, symptomatic congestive heart failure, stroke, mini-stroke (transient ischemic attack), or symptomatic blood clots in the lungs.
- People who had a serious infection requiring intravenous antibiotics, antifungal, or antiviral treatment within 4 weeks before the first dose, or who had an unexplained fever above 38.5°C during the screening period or before the first dose.
- People who are unable to swallow, have a bowel obstruction, or have any other condition that would affect the ability to take or absorb the study medications.
- People with a known allergy to any of the study medications or their ingredients, including albumin-bound paclitaxel, letrozole, anastrozole, Metrotan, LHRH agonists (such as goserelin or leuprorelin), Dalpiciclib (Darcilil), or any related substances.
- People with a known history of having received an organ transplant or bone marrow/stem cell transplant from another person.
- People with a known history of misusing substances or using illicit drugs.
- People with other serious physical or mental health conditions, significant abnormal laboratory results, or any other reason the study doctor considers would make participation unsafe or would interfere with the study results.
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.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
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Trial details
Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Fujian Medical University
Registry
ClinicalTrials.gov
Start date
1 January 2025
Est. completion
30 December 2027
Primary endpoints
ORR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 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.