Phase 2 Breast Cancer Trial, Not Yet Recruiting NCT07647029 Sponsor: Fudan University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Not Yet Recruiting

NCT07647029
Not Yet Recruiting Phase 2

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

  • Adults aged 18 or older.
  • People who have been diagnosed with breast cancer confirmed by laboratory analysis of tissue.
  • People who are currently receiving, or are expected to receive, chemotherapy-based cancer treatment in cycles of at least 21 days, with at least 2 cycles planned.
  • People whose general health and ability to carry out daily activities falls within an acceptable range (rated 0–2 on a standard medical scale, where 0 means fully active and 2 means up and about but unable to do physical work — confirm with trial site).
  • People whose platelet count meets one of the following during their previous treatment cycle: platelets dropped below 50×10⁹/L; or platelets dropped to between 50–75×10⁹/L alongside certain bleeding risk factors (see below); and platelets were at or above 100×10⁹/L at the time of enrolling in the trial.
  • People with breast cancer who also have another type of cancer, as long as the main treatment being given is for breast cancer.
  • People whose blood counts and organ function meet all of the following: white blood cell levels and haemoglobin are at acceptable levels; liver and kidney function test results are within acceptable limits; and blood clotting test results are within acceptable limits (confirm specific values with trial site).
  • Women who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose, must not be breastfeeding, and must agree to use effective contraception during the study and for 7 days after the last dose.
  • Men with female partners who could become pregnant must either have had a surgical procedure to prevent fathering children, or must agree to use effective contraception during the study and for 7 days after the last dose; sperm donation is not permitted during the study.
  • People with a life expectancy of at least 3 months.
  • People who are willing to take part voluntarily, sign a consent form, follow the study requirements, and attend follow-up appointments.
  • Bleeding risk factors referred to above include: a history of bleeding; previous treatment with certain chemotherapy drugs such as platinum agents, gemcitabine, cytarabine, anthracyclines, or PARP inhibitors (for example, niraparib); use of certain combinations of targeted and chemotherapy drugs known to raise the risk of low platelet counts; or a history of, or ongoing, radiotherapy — especially to long bones or flat bones such as the pelvis or sternum.

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 disorder, such as leukaemia, a condition where the immune system attacks platelets, certain bone marrow diseases, multiple myeloma, or myelodysplastic syndromes.
  • People who have an active infection that is not under control.
  • People who have a history of blood clots in arteries or veins.
  • People who have a tendency to bleed easily, or who have an inherited bleeding disorder or a problem with blood clotting.
  • Women who are pregnant or breastfeeding, or women who could become pregnant and are not using effective contraception.
  • People who have taken part in another clinical trial of platelet-boosting medications within the 4 weeks before enrolling.
  • People who have uncontrolled neurological or psychiatric conditions, or who would have difficulty following the study requirements or reporting side effects.
  • People whose cancer has spread into the bone marrow.
  • People who have received certain platelet-stimulating medications (rhTPO or rhIL-11) within 7 days before enrolling.
  • People who have a known allergy or serious sensitivity to the study drug or drugs.

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 1 July 2026

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Trial details

Status
Not Yet Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
28 May 2026
Est. completion
29 February 2028

Primary endpoints

Incidence of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)

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: 1 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