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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07116824
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 and sign a consent form
- People aged 18 or older
- People who have been confirmed through laboratory testing (tissue or cell samples) to have breast cancer that cannot be surgically removed, has come back locally, or has spread to other parts of the body
- People whose breast cancer tests positive for HER2 (a specific protein), confirmed by laboratory methods known as IHC 3+, or IHC 2+ with a positive ISH test
- People who have not previously had chemotherapy or HER2-targeted treatment for their unresectable, locally recurrent, or metastatic breast cancer (people who have had one round of hormone-based therapy are still considered; people whose cancer came back more than 12 months after finishing earlier adjuvant or pre-surgery chemotherapy or HER2-targeted therapy may also be considered)
- People who are generally able to carry out daily activities, rated 0 or 1 on a standard medical scale called the ECOG performance status (confirm with trial site)
- People who have at least one measurable area of cancer, as defined by a standard measurement system called RECIST 1.1, that has not been treated with local therapies such as radiotherapy (previously irradiated areas may be considered if the cancer has been confirmed to have progressed there; bone-only spread cannot be used as the measurable area)
- People whose blood cell counts meet required levels without having received a transfusion or blood-stimulating medication in the 14 days before testing — specifically: white blood cell levels (neutrophils) at or above 1.5 × 10⁹/L; platelet count at or above 100 × 10⁹/L; and haemoglobin at or above 90 g/L
- People whose liver function test results fall within required ranges (specific limits apply depending on whether liver spread is present — confirm with trial site)
- People whose kidneys are functioning well enough, with a calculated clearance rate of 60 mL/min or above
- People whose blood clotting measures are within acceptable ranges (with special consideration for those already on blood-thinning medication — confirm with trial site)
- People whose heart is pumping effectively, with a left ventricular ejection fraction (a measure of heart function) above 50%
- People whose life expectancy is at least 3 months
- Women who could become pregnant must have a negative pregnancy blood test within 7 days before joining, and must agree to use reliable contraception during the trial and for either 3 months after the last dose of docetaxel or HB1801, or 7 months after the last dose of trastuzumab or pertuzumab — whichever period is longer
- Male participants whose partners could become pregnant must agree to use reliable contraception during the trial and for either 3 months after the last dose of docetaxel or HB1801, or 7 months after the last dose of trastuzumab or pertuzumab — whichever period is longer
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 a medical reason to avoid trastuzumab, pertuzumab, or docetaxel, or whom the treating doctor considers unsuitable for any of the study drugs including HB1801
- People who have moderate-to-severe nerve damage in their hands or feet (Grade 3 or higher peripheral neuropathy) at the time of joining
- People who still have significant side effects from previous cancer treatment that have not settled back to a mild level (Grade 1 or lower), with some exceptions for hair loss, mild nerve symptoms, or certain blood test results the doctor considers low-risk (confirm with trial site)
- People who have previously experienced a significant drop in heart pumping function (below 50%), heart failure with symptoms, or had to permanently stop a HER2-targeted therapy due to heart-related side effects
- People who have a known allergy or medical reason to avoid corticosteroids (steroid medications), including conditions such as active stomach ulcers, severe high blood pressure, severe low potassium levels, or glaucoma
- People who have previously received high cumulative doses of certain chemotherapy drugs called anthracyclines, beyond specified limits (confirm with trial site for the specific dose thresholds that apply)
- People who have taken strong medications known to significantly affect how the body processes certain drugs (strong CYP3A4 inhibitors) within 14 days before joining
- People with a known allergy to any ingredient in the study drugs
- People who have brain or spinal metastases, cancer in the fluid around the brain and spine (leptomeningeal disease), or spinal cord compression that is untreated or unstable (people with treated, stable, symptom-free brain lesions for at least 4 weeks, with no swelling and no ongoing steroid use, may still be considered — confirm with trial site)
- People who have had another active cancer in the past 3 years, other than the breast cancer being studied or certain early-stage or locally treated cancers such as skin cancers, superficial bladder cancer, cervical or breast carcinoma in situ, or early thyroid cancer
- People with significant or uncontrolled heart or blood vessel problems, including: heart failure, unstable chest pain, heart attack, or serious irregular heartbeat within the past 6 months; certain types of heart muscle disease; a specific heart rhythm measurement (QTcF) above 450 ms on screening tests; a blood clot, stroke, or mini-stroke within the past 6 months; or uncontrolled high blood pressure above specific levels
- People with an active or ongoing infection requiring antibiotic or antiviral treatment within the past 14 days, including tuberculosis
- People with active hepatitis B (with a virus level at or above a certain threshold) or active hepatitis C (with detectable virus in the blood) — note that people who carry hepatitis B but have low virus levels may be considered if they are willing to take antiviral medication (confirm with trial site)
- People known to have HIV infection
- People currently taking part in another interventional clinical trial, or who received treatment in another interventional trial less than 4 weeks ago
- People who have received cancer treatments — including radiotherapy, targeted therapy, immunotherapy, or experimental drugs — within the past 28 days, or certain traditional Chinese medicine with anti-tumour properties within the past 14 days
- People who have had fluid build-up around the lungs, abdomen, or heart within the past 7 days that required repeated draining or medical intervention, or that needed further intervention within 2 weeks
- People who have had major surgery within the past 28 days (not including minor procedures such as biopsies)
- People who are pregnant or currently breastfeeding
- People with other conditions that the trial team considers would prevent safe participation or reduce the likelihood of benefit, such as significant psychiatric illness, substance misuse, or serious additional health conditions
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
15 September 2025
Est. completion
15 July 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.
Primary endpoints
Objective Response Rate (ORR) as assessed by RECIST 1.1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 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.