Printed from Voxsanity (voxsanity.com.au) — NCT07684456 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Breast Cancer Trial, Not Yet Recruiting
NCT07684456
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 have been fully informed about the study's goals, process, and possible side effects, and have agreed to take part by signing a consent form.
- People aged 18 to 75 years old.
- Men or women who are generally able to carry out daily activities with little or no limitation (rated 0 or 1 on a standard health performance scale).
- People who have been diagnosed with HER-2 negative advanced breast cancer confirmed through a tissue sample test.
- People whose breast cancer has spread to nearby tissues, come back after previous treatment, or spread to other parts of the body.
- People who have previously been treated with chemotherapy that included at least one drug from the taxane or anthracycline families of medicines.
- People whose breast cancer is hormone receptor positive and whose cancer has continued to grow despite hormone-based treatment.
- People who have at least one tumour that can be measured using standard imaging guidelines (RECIST 1.1).
- People who are expected to live for at least 12 weeks.
- People whose routine blood test results are within the normal range at the start of the study.
- People whose liver and kidney function test results are within the normal range at the start of the study.
- People who are able to have children must agree to use effective contraception during the study and for at least 6 months after the last dose, and their partners must do the same; women who could become pregnant must have a negative pregnancy test before joining.
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 received standard anti-cancer treatments within the 4 weeks before starting the study drug.
- People who have used Capecitabine or Utidelone within the 6 months before being assigned to a study group.
- People whose breast cancer has spread to the brain or the lining around the brain and spinal cord.
- People with bone metastases that cannot be controlled, or who have a high risk of bone fracture, or who recently needed or are expected to need surgery or targeted radiation to the bones, or who have other serious related conditions.
- People with fluid build-up around the lungs, heart, or abdomen that cannot be controlled and requires draining at least once a month.
- People with serious heart or blood vessel disease.
- People with mental health conditions that are difficult to manage, or who are not able to make legal decisions for themselves.
- People with digestive system problems that would prevent them from swallowing or absorbing oral medication.
- People who currently have an active infection that requires treatment throughout the body.
- People who have nerve damage in their hands or feet rated at level 2 or higher at the time of joining the study.
- People who still have side effects rated at level 2 or higher from previous cancer treatments (with some exceptions, such as hair loss, at the investigator's discretion).
- People who have had major surgery or a serious physical injury in the 4 weeks before joining, or who are expected to need major surgery during the study period (routine procedures such as biopsies are not included).
- People who have received radiation therapy within 2 weeks before being assigned to a study group.
- People who are currently taking part in another clinical trial or receiving another experimental treatment.
- People who have had another type of cancer in the past 5 years, with the exception of certain cancers considered fully cured, such as early-stage cervical cancer, certain skin cancers, or papillary thyroid cancer.
- People who are allergic to castor oil; people who have had a severe allergic reaction to fluorouracil-based medicines in the past; or people known to have a deficiency of an enzyme called DPD.
- People who are pregnant or currently breastfeeding.
- People whom the study investigator considers unsuitable to take part 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.
Contact this trial
Phone: 010-56315388
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 3
Sponsor
Beijing Biostar Pharmaceuticals Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 March 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression-Free Survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 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.