Printed from Voxsanity (voxsanity.com.au) — NCT06605690 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Breast Cancer
Breast Cancer Trial, Not Yet Recruiting
NCT06605690
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 who are postmenopausal — either through surgical removal of both ovaries, being aged 60 or older, or (if under 60) having had no natural menstrual period for at least 12 consecutive months, with hormone test results confirming postmenopausal levels.
- People whose breast cancer has tested positive for estrogen receptors (more than 10%) and negative for the HER2 protein, confirmed by laboratory testing, regardless of progesterone receptor status.
- People being treated for the first time for stage II or stage III breast cancer, as classified under the AJCC 8th edition staging system.
- People with no known history of severe allergic reactions to dalpiciclib, anlotinib, or compounds similar to these medications or their ingredients.
- People with a general health performance score of 0 or 1 on the ECOG scale, meaning fully active or restricted in strenuous activity but able to carry out light work (confirm with trial site).
- People who are able to swallow oral (by mouth) medications.
- People whose bone marrow is functioning adequately, shown by blood counts meeting specific thresholds without recent use of supportive medications (confirm with trial site for exact values).
- People whose liver and kidney function test results fall within the acceptable ranges specified by the trial (confirm with trial site for exact values).
- People whose heart's electrical activity, measured by a 12-lead ECG, shows a QT interval of 480 milliseconds or less.
- People who are able and willing to undergo two tissue biopsy procedures — one at the time of first diagnosis and one on day 15 of treatment.
- People who are willing to voluntarily participate, sign an informed consent form, follow the study requirements, and attend follow-up appointments.
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 received any form of cancer treatment, including chemotherapy, radiotherapy, targeted therapy, or hormone therapy.
- People who are currently receiving any other anti-cancer treatment outside of what is specified in this trial.
- People with bilateral breast cancer (cancer in both breasts), inflammatory breast cancer, or locally advanced breast cancer that cannot be surgically removed (confirm with trial site for exact definition of "ocessive").
- People with stage IV (advanced/metastatic) breast cancer.
- People who have had another cancer diagnosed within the past 5 years.
- People with serious problems affecting the heart, liver, kidneys, or other vital organs.
- People who are unable to swallow, have chronic diarrhoea, or have a bowel obstruction that could affect how medication is absorbed.
- People with a known allergy to any of the medications used in this trial, or people with immune system conditions including HIV, hepatitis C (HCV), active hepatitis B, other immunodeficiency diseases, or a history of organ transplantation.
- Women who are pregnant or breastfeeding, or women of childbearing potential who test positive for pregnancy at the start of the trial or who are unwilling to use effective contraception throughout the entire study period.
- People with other existing medical conditions that, in the treating doctor's judgement, could seriously affect their safety or their ability to complete the study — including uncontrolled high blood pressure, severe diabetes, or active infections.
- People considered at high risk of coughing up blood, including those with uncontrolled high blood pressure, blood disorders such as idiopathic thrombocytopenic purpura or thrombocytopenia, lung conditions such as active tuberculosis or bronchiectasis, or chronic liver diseases such as cirrhosis or portal hypertension.
- People with a known neurological or psychiatric condition, such as epilepsy or dementia, or anyone the treating doctor considers unsuitable for participation for any other reason.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Liu Shu
Registry
ClinicalTrials.gov
Start date
31 October 2024
Est. completion
31 August 2025
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
ORR
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.