Phase 2 Breast Cancer Trial, Not Yet Recruiting
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 70 years.
- People with a laboratory-confirmed diagnosis of a specific type of breast cancer that is hormone receptor (HR)-positive and HER2-negative, which is either locally advanced (meaning surgery or other local treatment is not possible) or has spread to other parts of the body, and whose cancer has been digitally classified as a specific subtype called SNF1 or SNF3 (confirm with trial site).
- People whose cancer got worse after treatment with a type of drug called a CDK 4/6 inhibitor, under specific timing conditions depending on when and how that drug was used (confirm with trial site for exact timing requirements).
- People who have received no more than one course of systemic treatment since their cancer spread or returned.
- People who have at least one measurable area of cancer that can be tracked during the trial.
- People whose blood, liver, and kidney function meet specific minimum levels set by the trial (confirm with trial site for exact values).
- People who have not received hormone therapy, targeted therapy, or surgery within the 3 weeks before starting the study, and who have fully recovered from any side effects of previous treatment.
- People who received radiotherapy must have fully recovered from its effects, with at least 14 days passed since the end of radiotherapy before joining the trial.
- People who received chemotherapy must have recovered to a low level of side effects (with exceptions for hair loss and certain nerve-related symptoms), with at least 21 days passed since the last chemotherapy dose before joining the trial.
- People who are able to swallow oral (tablet or capsule) medications.
- People with a general health score (ECOG) of 0 or 1, and a life expectancy of at least 3 months.
- Women who could become pregnant must agree to use an approved method of contraception during the study and for at least 3 months after the last dose of the study drug.
- People who are willing to take part voluntarily, sign a consent form, and commit to attending 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 had radiotherapy within the 3 weeks before starting treatment.
- People with known or suspected cancer that has spread to the brain or spinal cord (central nervous system), or who have a history of this.
- People who have previously experienced a fainting episode related to a heart condition, a serious abnormal heart rhythm (such as ventricular tachycardia or ventricular fibrillation), or sudden cardiac arrest.
- People with an active bacterial infection currently requiring intravenous antibiotics, an active fungal infection, or a detectable viral infection such as HIV, active hepatitis B, or active hepatitis C.
- People with serious or uncontrolled pre-existing health conditions that the trial doctor believes would make participation unsafe — for example, certain lung conditions, severe breathing problems, severely reduced kidney function, a history of major stomach or bowel surgery, Crohn's disease, ulcerative colitis, or a long-term condition causing ongoing moderate-to-severe diarrhoea.
- People who still have ongoing side effects of grade 1 or higher from previous treatment (with some exceptions at the trial doctor's discretion, which must be recorded).
- People who have had major surgery within 14 days before joining the trial.
- People who are pregnant or currently breastfeeding.
- People who have had another cancer in the past 5 years (except certain fully cured skin cancers or early-stage cervical conditions).
- People who are unable to swallow, or who have chronic diarrhoea, a bowel obstruction, or other conditions that would significantly affect how the study medication is taken or absorbed.
- People with uncontrolled build-up of fluid in body cavities (such as large amounts of fluid around the lungs or in the abdomen) that cannot be managed by draining.
- People with wounds that have not healed over a long period of time, or fractures that have not fully healed.
- People with known allergies to any ingredients in the study drugs.
- People who are currently taking oral steroid hormones long-term, or who have used them in the past and have not had a 4-week break before joining the trial.
- People who have previously been treated with certain drugs that target a pathway called PAM (such as Everolimus) or PARP inhibitors (such as Fluzoparib).
- People who have received any chemotherapy drugs since their cancer spread or returned.
- People who have already received the specific treatment combination being tested in the control group of this trial (Abemaciclib combined with Fulvestrant) since their cancer spread or returned.
- People who have received CDK 4/6 inhibitor treatment for more than one treatment period.
- People who have taken part in another clinical trial within the last 30 days or 5 half-lives of the experimental drug (whichever is longer), or who are currently enrolled in another research study that the trial sponsor considers incompatible with this one.
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.
Contact this trial
Principal Investigator: Zhimin C Shao, MD, PhD, Fudan U
Phone: 02164175590
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
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.
Where this trial is recruiting
Primary endpoints
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0( Safety lead-in Phase); objective response rate (ORR)( Safety lead-in Phase); Progression-free survival (PFS)(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.