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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT05983094
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 who have not yet started treatment for breast cancer.
- People newly diagnosed with high-risk early-stage or locally advanced breast cancer (stage II or III), covering several breast cancer types: triple negative breast cancer (TNBC), HER2-positive breast cancer, hormone receptor (HR)-negative HER2 borderline breast cancer, and HR-positive HER2-negative breast cancer — all confirmed by tissue testing; HR-positive/HER2-negative patients with a T2, N0 tumour must also have additional high-risk features (high histological grade 3 or a Ki67 level of 20% or more) (confirm with trial site).
- People with a good general level of physical fitness and ability to carry out daily activities, rated 0 or 1 on a standard oncology performance scale.
- People whose routine blood test results are within an acceptable range in the week before joining, without having used certain blood-boosting medications (such as growth factors, blood transfusions, or EPO) in the 14 days before joining.
- People whose blood cell counts meet specific minimum levels: white blood cells, neutrophils, platelets, and haemoglobin all at or above defined thresholds (confirm exact values with trial site).
- People whose liver and kidney function blood test results are within an acceptable range in the week before joining, including normal levels of bilirubin, liver enzymes (AST, ALT, alkaline phosphatase), and creatinine.
- People whose heart pumping function (left ventricular ejection fraction) is 55% or above on an echocardiogram (heart ultrasound).
- Women who are able to become pregnant must agree to use effective contraception during the study and for 6 months after the last dose, and must have a negative pregnancy test (urine or blood) before joining.
- People who are willing and able to give written consent to participate in the trial.
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 whose breast cancer has already spread to distant parts of the body (stage IV).
- People diagnosed with inflammatory breast cancer.
- People with primary breast cancer in both breasts at the same time (including both invasive cancer and non-invasive cancer in situ).
- People who have previously had any anti-cancer treatment or radiotherapy for any cancer, except for fully treated cervical carcinoma in situ, basal cell skin cancer, or squamous cell skin cancer.
- People currently receiving any sex hormone treatments (such as hormonal contraceptives or hormone replacement therapy), unless it is for ovarian function suppression for fertility protection; or people taking any hormone-type medicines such as raloxifene, tamoxifen, or similar drugs to treat osteoporosis or reduce breast cancer risk.
- People who have had major surgery unrelated to their breast cancer within 4 weeks before starting treatment, or who have not fully recovered from such surgery.
- People who have moderate or severe nerve damage causing symptoms in their hands or feet (peripheral neuropathy graded 2 or higher on a standard scale).
- People with serious heart or blood vessel conditions, including any of the following: a history of heart failure or poor heart pumping function (ejection fraction below 50%); chest pain (angina) requiring ongoing medication; uncontrolled or dangerous irregular heart rhythms or significant problems with the heart's electrical conduction; an abnormal heart electrical reading (QTcF interval above 470ms); significant heart valve disease affecting heart function; high blood pressure that cannot be controlled; or a history of heart attack.
- People who are allergic to any ingredient in any of the drugs used in this trial.
- People for whom steroid (corticosteroid) medicines are not suitable.
- People who currently have an active infection requiring ongoing treatment with anti-infection medicines.
- People with a history of immune deficiency conditions, including HIV/AIDS, other inherited or acquired immune disorders, or a history of organ transplantation.
- People who have participated in another drug clinical trial within 28 days before joining, or who are currently in another clinical trial or using another experimental treatment.
- People who are pregnant or breastfeeding.
- People with other serious health conditions that may interfere with the treatment plan, or whom the treating doctor considers unsuitable to participate 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.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Registry
ClinicalTrials.gov
Start date
1 September 2023
Est. completion
1 September 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Total pathological complete response (etpCR, Pathologic staging after neoadjuvant therapy(yp)T0/is, (yp)N0)
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.