A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae (PROTECT)

June 9, 2026 updated by: Jian Zhang,MD, Fudan University

This study is a prospective clinical study enrolling breast cancer patients at high risk of chemotherapy-induced thrombocytopenia (CTIT). It aims to investigate the efficacy and safety of hetrombopag in the secondary prophylaxis of CTIT.

Breast cancer patients with histologically or cytologically confirmed disease were enrolled after signing the informed consent form and were randomly assigned in a 1:1:1 ratio to three Arms. Stratification factors for randomization included the number of prior antineoplastic treatment cycles (>2 cycles vs. ≤2 cycles).

Arm 1: No prophylactic use of hetrombopag Arm 2: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle Arm 3: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle; Treatment continued until patients completed the protocol-specified treatment and follow-up, experienced intolerable toxicity, withdrew informed consent, initiated alternative antitumor therapy, died, or met any other treatment discontinuation criteria specified in the protocol, whichever occurred first.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. Patients with histopathologically confirmed breast cancer;
  3. Receiving or expected to receive chemotherapy-based antitumor therapy with a cycle length of ≥21 days, and anticipated to receive ≥2 cycles of therapy;
  4. ECOG performance status 0-2;

  5. Platelet count meeting **one** of the following criteria:

    1. Nadir platelet count < 50×10⁹/L in the previous antitumor treatment cycle;
    2. Nadir platelet count ≥ 50×10⁹/L but < 75×10⁹/L in the previous antitumor treatment cycle, accompanied by **high risk factors for bleeding***;
  6. Platelet count ≥ 100×10⁹/L at enrollment;
  7. Patients with breast cancer plus other malignancies are allowed, provided that the treatment plan is primarily for breast cancer;

  8. Adequate organ function:

    • Bone marrow: ANC ≥ 1.5×10⁹/L; hemoglobin ≥ 8 g/dL;

      • Hepatic and renal function: total bilirubin ≤ 1.5 × ULN; ALT, AST ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastasis); serum creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min (Cockcroft-Gault formula);

        • Coagulation: activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN;

  9. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, not be breastfeeding, and agree to use effective contraception during the study and for 7 days after the last dose of study drug.

    Male subjects with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 7 days after the last dose of study drug; sperm donation is prohibited during the study;

  10. Life expectancy ≥ 3 months;

  11. Voluntarily participate in the study, sign the informed consent form, have good compliance, and be willing to comply with follow-up procedures.

    • High risk factors for bleeding History of bleeding; prior treatment with platinum agents, gemcitabine, cytarabine, anthracyclines, PARP inhibitors (e.g., niraparib), etc.; combination of targeted agents and chemotherapeutic agents known to increase the risk of thrombocytopenia; history of radiotherapy or ongoing radiotherapy, especially to long bones and flat bones (e.g., pelvis, sternum).

Exclusion Criteria:

  1. Presence of hematological disorders, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative neoplasms, multiple myeloma, and myelodysplastic syndromes;
  2. Uncontrolled active infection;
  3. History of arterial or venous thrombosis;
  4. Patients with bleeding tendency, or evidence of inherited bleeding diathesis or coagulation disorders;
  5. Pregnant or breastfeeding women, or female patients of childbearing potential not using effective contraception;
  6. Participation in another clinical trial of thrombopoietic agents within 4 weeks prior to enrollment;
  7. Presence of uncontrolled neurological or psychiatric disorders, poor compliance, or inability to cooperate and report treatment-related reactions;
  8. Bone marrow involvement;
  9. Administration of rhTPO or rhIL-11 within 7 days prior to enrollment;
  10. Hypersensitivity to the study drug(s).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No prophylactic use of hetrombopag
Experimental: Continuous Hetrombopag for 2 Cycles
Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle
Drug: Continuous Hetrombopag for 2 Cycles
Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle
Experimental: Cyclic 14-day Hetrombopag for 2 Cycles
Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle
Drug: Cyclic 14-day Hetrombopag for 2 Cycles
Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Time Frame: At the end of Cycle 2 (each cycle ≥21 days)
At the end of Cycle 2 (each cycle ≥21 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of grade ≥2 thrombocytopenia (PLT < 75×10⁹/L)
Time Frame: At the end of Cycle 2 (each cycle ≥21 days)
At the end of Cycle 2 (each cycle ≥21 days)
Incidence and duration of grade ≥3 thrombocytopenia (PLT < 50×10⁹/L)
Time Frame: At the end of Cycle 2 (each cycle ≥21 days)
At the end of Cycle 2 (each cycle ≥21 days)
Proportion of patients who successfully completed two chemotherapy cycles without thrombocytopenia-related modifications to subsequent antineoplastic therapy
Time Frame: At the end of Cycle 2 (each cycle ≥21 days)
At the end of Cycle 2 (each cycle ≥21 days)
Proportion of patients without rescue therapy for thrombocytopenia (e.g., platelet transfusion, interleukin-11, recombinant human thrombopoietin)
Time Frame: At the end of Cycle 2 (each cycle ≥21 days)
At the end of Cycle 2 (each cycle ≥21 days)
Nadir and peak platelet counts
Time Frame: At the end of Cycle 2 (each cycle ≥21 days)
At the end of Cycle 2 (each cycle ≥21 days)
Incidence of adverse events
Time Frame: From enrollment to 21 days after the last dose of study drug
From enrollment to 21 days after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 28, 2026

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

May 23, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2603340-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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