Printed from Voxsanity (voxsanity.com.au) — NCT07173556 — 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
NCT07173556
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, understand what the trial involves, and agree to follow the study requirements.
- People aged 18 years or older.
- Female participants must be postmenopausal and meet the specific trial requirements (confirm with trial site).
- People whose general health and ability to carry out daily activities is rated at a score of 0 or 1 on a standard oncology scale (meaning fully active or restricted only in physically strenuous activity).
- People with a life expectancy of at least 3 months.
- People whose breast cancer has been confirmed through laboratory testing of tissue samples.
- People whose most recent tumour biopsy shows the cancer is hormone receptor-positive (ER-positive) and HER2-negative, confirmed through standard laboratory staining tests.
- People who have at least one tumour that can be measured according to standard response criteria (RECIST v1.1).
- People with adequate bone marrow function within 2 weeks before starting the study treatment, without needing blood transfusions or growth factor support.
- People with adequate liver function (confirm specific values with trial site).
- People whose kidney function meets the required levels, with no significant or hard-to-correct electrolyte imbalances.
- People whose blood clotting function falls within the required range on standard laboratory tests.
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 active symptoms affecting internal organs, or whose condition is considered by the treating doctor to be unsuitable for hormone-based therapy.
- People who still have unresolved side effects from previous treatments that have not improved to a mild level or below (with exceptions for hair loss and certain other effects considered low risk by the treating doctor).
- People who received anti-cancer drug treatment within a specified period before the first dose of the study drug (confirm the exact timeframe with the trial site).
- People who have previously been treated with an experimental SERD or experimental oestrogen receptor antagonist.
- People who received radiation therapy within 4 weeks before the first dose of the study drug.
- People who used a strong CYP3A4 inhibitor (a type of medication that affects how drugs are broken down in the body) within 7 days or 5 half-lives before the first dose, whichever is the longer period.
- People who had major surgery within 4 weeks before the first dose of the study drug, have not fully recovered from surgery, or have significant injuries, wounds that are not healing, or fractures.
- People who have had another active cancer within the 5 years before the first dose of the study drug.
- People with known active cancer spread to the brain or spinal fluid.
- People who are unable to swallow tablets or capsules, or who have a digestive condition that may prevent the study drug from being properly absorbed.
- People with known serious liver disease, including moderate to severe liver impairment (Child-Pugh class B or C), active viral hepatitis, or other significant hepatitis.
- People who currently have inflammation of the lungs (pneumonitis) or scarring of the lung tissue (interstitial lung disease) rated at grade 1 or higher.
- People with significant fluid build-up around the lungs, in the abdomen, or around the heart that has required draining or extra medication within the past 2 weeks.
- People with clinically significant heart disease that is not well controlled, or who have had a recent significant cardiac event.
- People with a history of abnormal bleeding, blood clots, or tumour-related blood vessel blockages.
- People planned to receive the drug everolimus who also have diabetes that is not well controlled despite appropriate treatment.
- People who are allergic to any of the study drugs or their ingredients.
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
Phone: 021-64175590
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Qilu Pharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 February 2027
Primary endpoints
Safety and Tolerability (Phase Ib); Recommended phase II dose (RP2D) (Phase Ib); Objective Response Rate (ORR) (Phase II)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 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.