Could a platelet booster keep chemotherapy on track for breast cancer patients?
NCT ID NCT07771881
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether romiplostim, a drug that stimulates platelet production, can prevent chemotherapy-induced thrombocytopenia (low platelet counts) in breast cancer patients. The study enrolls adults aged 18 to 75 with breast cancer who experienced low platelets after a previous chemotherapy cycle. Participants receive romiplostim injections weekly, with doses adjusted based on platelet counts, to see if it can maintain platelet levels and reduce the need for treatment delays or dose reductions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Romiplostim N01 for injection
- What this could lead to
- If effective, this could offer a way to prevent severe platelet drops in breast cancer patients, reducing bleeding risks and avoiding chemotherapy delays or dose reductions.
- What could go wrong
- This is an early-phase study with a small number of participants, so results may not apply broadly. Romiplostim can have side effects, and its long-term safety in this setting is not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 53 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed informed consent form. 2. Age 18 to 75 years, either sex. 3. Histologically or pathologically confirmed breast cancer. 4. Nadir platelet count \<50×10⁹/L in the previous treatment cycle; OR nadir platelet count ≥50×10⁹/L but \<75×10⁹/L in the previous chemotherapy cycle, plus at least one high-risk factor for bleeding as defined in the relevant guideline. 5. Platelet count \>100×10⁹/L at screening. 6. No prior exposure to romiplostim/romiplostim N01. 7. Prior receipt of one or more antineoplastic therapies, including but not limited to chemotherapy, radiotherapy, targeted therapy, and immunotherapy. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 9. Life expectancy of ≥12 weeks. Exclusion Criteria: 1. Concomitant hematologic disorders; 2. Prior radiation therapy to long bones or flat bones, or currently receiving/planned to receive radiation therapy (local radiation to the breast is permitted); 3. Serious cardiac clinical symptoms or diseases within 6 months prior to screening; 4. Thrombotic predisposition or currently receiving thrombolytic and/or anticoagulant therapy; 5. Clinically significant bleeding symptoms within 2 weeks prior to screening, or definitive clinical manifestations of bleeding tendency; 6. Complications requiring emergency treatment, such as superior vena cava syndrome or spinal cord compression; 7. Significantly abnormal hepatic function: for patients without hepatic metastasis, ALT/AST \>3×ULN and TBIL \>3×ULN; for patients with hepatic metastasis, ALT/AST ≥5×ULN and TBIL ≥5×ULN; 8. Renal function abnormality: serum creatinine ≥1.5×ULN or eGFR ≤60 mL/min (by Cockcroft-Gault formula); 9. Receipt of romiplostim within 2 to 3 weeks prior to study drug administration; 10. Known or suspected hypersensitivity or intolerance to romiplostim N01 or its excipients (including cellulose-lactose, low-substituted hydroxypropyl cellulose, and magnesium stearate); 11. HIV infection; 12. Participation in any other clinical study of an investigational drug or device within 3 months prior to screening; 13. Pregnant or lactating women; 14. Any other condition that, in the investigator's opinion, may affect study results or lead to premature discontinuation of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
Shanghai, China
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