Breast Cancer Trial, Recruiting NCT06765590 Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT06765590
Recruiting Not Applicable

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 voluntarily agreed to take part and have signed the required consent forms
  • People who have been diagnosed with breast cancer confirmed by laboratory testing of tissue or cells, and who either: have metastatic or recurrent breast cancer that did not respond to combination chemotherapy (or came back within 6 months of finishing chemotherapy), with a specific type of chemotherapy drug called an anthracycline used previously unless medically unsuitable; or have been assessed by the trial doctor as a candidate for albumin-bound paclitaxel based on recognised breast cancer treatment guidelines
  • People aged 18 to 75 years old (inclusive), of any sex, with a body mass index (a measure of body weight relative to height) of 17 or above
  • People with an ECOG performance score of 0 to 2 (a scale used by doctors to measure how much a person's cancer affects their daily activities — confirm with trial site)
  • People whose doctors expect them to survive for at least 3 months
  • People who have no plans to become pregnant or donate eggs or sperm during the trial and for 6 months after the last dose, and who agree to use non-hormonal contraception (such as abstinence, condoms, a contraceptive ring, or vasectomy) or other highly effective contraceptive methods throughout
  • People whose recent blood test results meet specific thresholds for red blood cells, white blood cells, platelets, liver function, kidney function, and blood clotting — exact values would be assessed by the trial site
  • People who are able to communicate clearly with the research team and are willing and able to follow the study requirements

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 with a general tendency toward allergies (beyond mild seasonal allergies with no symptoms), or who are known or suspected to be allergic to paclitaxel or albumin (ingredients in the study drug)
  • People who received radiotherapy, chemotherapy, immunotherapy, or hormone therapy within 4 weeks before starting the study drug and are still responding to that treatment
  • People who have had a serious illness affecting the heart, brain, blood vessels, lungs, liver, kidneys, digestive system, hormonal system, immune system, skin, muscles, bones, nervous system, or mental health within 3 months before screening, and who the trial doctor considers unsuitable for enrolment
  • People who had major surgery or a bone fracture within 4 weeks before screening, or who plan to have major surgery during the trial
  • People who took part in another clinical trial involving an experimental drug within 4 weeks before this study
  • People who have taken certain medications that affect how the body processes the study drug (involving liver enzymes called CYP2C8 and CYP3A4) within 4 weeks before the first dose, or who cannot stop taking those medications during the study — the trial site can advise on which specific medications are included
  • People who consumed certain foods (such as grapefruit, pomelo, or mango), exercised vigorously, or had other factors that could affect how the body handles the drug within 48 hours before receiving the study drug
  • People who received a white blood cell–stimulating medication called G-CSF within 2 weeks before screening
  • People with moderate or severe nerve damage (numbness, tingling, or pain in the hands or feet) rated at grade 2 or higher at the time of screening
  • People who have had a heart attack within 6 months before the study, or who have severe or unstable chest pain (angina), severe heart failure, or have had heart or artery bypass surgery
  • People with high blood pressure that is not well controlled (above 160/100 mmHg) even while on blood pressure medication
  • People who have a tendency to bleed, are receiving blood-thinning or clot-dissolving treatment, or have donated or lost more than 400 mL of blood within 3 months before the study drug is given
  • People with clinically significant abnormalities on a 12-lead heart tracing (ECG) that the trial doctor considers unsuitable for enrolment
  • People with a history of heavy alcohol use (more than 14 standard drinks per week in the 6 months before the first dose), drug misuse or addiction, or who smoked more than 5 cigarettes per day in the 3 months before screening — or who are unable to stop smoking or drinking from the time of signing the consent form until completing the study
  • People who test positive for hepatitis B, hepatitis C, HIV, syphilis, or related markers
  • Women who are pregnant or breastfeeding
  • People whom the trial doctor considers unsuitable 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.
Last synced 31 July 2026
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.

Contact this trial

Phone: 02886021875

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
Recruiting
Phase
Not Applicable
Sponsor
Sichuan Huiyu Pharmaceutical Co., Ltd
Registry
ClinicalTrials.gov
Start date
12 March 2025
Est. completion
12 June 2026

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

🇨🇳 China

Primary endpoints

Maximum observed concentration of paclitaxel (Cmax); Area under the concentration-time curve from time zero to infinite time of paclitaxel (AUC 0-inf); Area under the concentration-time curve from time zero to the last time of paclitaxel (AUC 0-t)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 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.

View original record on ClinicalTrials.gov