Printed from Voxsanity (voxsanity.com.au) — NCT07162519 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Breast Cancer Trial, Not Yet Recruiting
NCT07162519
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
- The person must sign a consent form before enrolling in the trial.
- People between 18 and 75 years of age.
- People who have been diagnosed with breast cancer confirmed through laboratory testing of tissue samples.
- People with breast cancer whose platelet count has dropped as a result of chemotherapy (a condition called chemotherapy-induced thrombocytopenia).
- People who have not been treated with romiplostim or romiplostim N01 in the past 3 months.
- People with a general health and activity level rated between 0 and 2 on a standard medical scale (meaning able to carry out at least some daily activities — confirm with trial site).
- People whose platelet count is below 75×10⁹/L (a measure of how many platelets are in the blood — confirm with trial site for the exact value).
- People whose doctors expect them to live for at least 12 weeks at the time of screening.
- People who are capable of having children must agree to use reliable contraception throughout the study, such as condoms, contraceptive foam, gel, film, cream, suppositories, abstinence, or an intrauterine device; this requirement does not apply to people who have had a hysterectomy, removal of both fallopian tubes, tubal ligation, have been through menopause for more than one year, or have had a vasectomy or ligation.
- People who are willing to take part voluntarily, sign the consent form, and 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 who have a blood or bone marrow disease other than chemotherapy-related low platelets, such as leukemia, immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, or myelodysplastic syndromes.
- People whose low platelet count in the 6 months before screening was caused by something other than chemotherapy, such as chronic liver disease, an enlarged spleen, infection, or bleeding.
- People whose cancer has spread into the bone marrow.
- People who had radiation therapy to the pelvis, spine, or large areas of bone within the 3 months before screening, or who are currently receiving or planning to receive such treatment.
- People who have had serious heart problems in the 6 months before screening, such as severe heart failure, certain irregular heart rhythms that raise the risk of blood clots (such as atrial fibrillation), or who have had a heart stent, angioplasty, or bypass surgery.
- People who have had serious bleeding episodes in the 2 weeks before screening, such as bleeding in the stomach, intestines, or brain.
- People who have tumours in the brain or cancer that has spread to the brain.
- People who have urgent conditions that need emergency treatment, such as superior vena cava syndrome (blockage of a major vein near the heart) or spinal cord compression.
- People whose neutrophil count (a type of infection-fighting white blood cell) is below 1.0×10⁹/L, or whose haemoglobin level is below 80 g/L (certain supportive treatments are still allowed — confirm with trial site).
- People with significant liver problems — specific cut-off levels based on blood test results apply, and these vary depending on whether the cancer has spread to the liver (confirm with trial site for exact values).
- People with significant kidney problems, based on blood test results or a calculation of kidney function (confirm with trial site for exact values).
- People who are known or expected to have an allergic reaction or intolerance to romiplostim N01 or related ingredients.
- People who are living with HIV.
- People who are pregnant or currently breastfeeding.
- People who have taken part in another clinical trial involving an experimental drug or device within the 3 months before screening.
- People whom the trial investigators consider to be at significant risk, or whose participation may affect the reliability of the trial results.
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.
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: +8618622221183
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
20 September 2025
Est. completion
30 August 2026
Primary endpoints
2-week response rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 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.