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

NCT07647029 | Not Yet Recruiting Phase 2

• 1 other identifier: 2603340-13
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)

Keywords

Breast cancer; Secondary prophylaxis; Hetrombopag; Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

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

  At the end of Cycle 2 (each cycle ≥21 days)

Secondary Outcomes (6)

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

  At the end of Cycle 2 (each cycle ≥21 days)

• Incidence and duration of grade ≥3 thrombocytopenia (PLT < 50×10⁹/L)

  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

  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)

  At the end of Cycle 2 (each cycle ≥21 days)

• Nadir and peak platelet counts

  At the end of Cycle 2 (each cycle ≥21 days)

Study Arms (3)

No prophylactic use of hetrombopag

NO INTERVENTION

No prophylactic use of hetrombopag

Continuous Hetrombopag for 2 Cycles

EXPERIMENTAL

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

Cyclic 14-day Hetrombopag for 2 Cycles

EXPERIMENTAL

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

Interventions

Continuous Hetrombopag for 2 Cycles DRUG

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

Continuous Hetrombopag for 2 Cycles

Cyclic 14-day Hetrombopag for 2 Cycles DRUG

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

Cyclic 14-day Hetrombopag for 2 Cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Patients with histopathologically confirmed breast cancer;
• Receiving or expected to receive chemotherapy-based antitumor therapy with a cycle length of ≥21 days, and anticipated to receive ≥2 cycles of therapy;
• ECOG performance status 0-2;
• Platelet count meeting \*\*one\*\* of the following criteria:
• Nadir platelet count \< 50×10⁹/L in the previous antitumor treatment cycle;
• Nadir platelet count ≥ 50×10⁹/L but \< 75×10⁹/L in the previous antitumor treatment cycle, accompanied by \*\*high risk factors for bleeding\*\*\*;
• Platelet count ≥ 100×10⁹/L at enrollment;
• Patients with breast cancer plus other malignancies are allowed, provided that the treatment plan is primarily for breast cancer;
• 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;
• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Related Publications (7)

• Qin S, Wang Y, Yao J, Liu Y, Yi T, Pan Y, Chen Z, Zhang X, Lu J, Yu J, Zhang Y, Cheng P, Mao Y, Zhang J, Fang M, Zhang Y, Lv J, Li R, Dou N, Tang Q, Ma J. Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study. Ther Adv Med Oncol. 2024 Jun 14;16:17588359241260985. doi: 10.1177/17588359241260985. eCollection 2024.

  PMID: 38882443 BACKGROUND

• Kuter DJ. Treatment of chemotherapy-induced thrombocytopenia in patients with non-hematologic malignancies. Haematologica. 2022 Jun 1;107(6):1243-1263. doi: 10.3324/haematol.2021.279512.

  PMID: 35642485 BACKGROUND

• Jin G, Wu Y, She Z, Ma X, Deng S, Wang W, Wu Y, Li Q. Prophylactic Administration of Recombinant Human Thrombopoietin in the Secondary Prevention of Thrombocytopenia Induced by XELOX Adjuvant Chemotherapy in Patients With Stage III Colorectal Cancer. Am J Ther. 2021 Apr 7;28(4):e513-e516. doi: 10.1097/MJT.0000000000001331. No abstract available.

  PMID: 33852489 BACKGROUND

• Li Q, Jin G, Jiang C, Zhang Z, Hou J, Zhao J, Chen F, Li Z. Prophylactic administration of recombinant human thrombopoietin attenuates XELOX or SOX regimen-induced thrombocytopaenia. Arch Med Sci. 2021 Aug 9;17(5):1440-1446. doi: 10.5114/aoms/141134. eCollection 2021. No abstract available.

  PMID: 34522277 BACKGROUND

• Xu Y, Song X, Du F, Zhao Q, Liu L, Ma Z, Lu S. A Randomized Controlled Study of rhTPO and rhIL-11 for the Prophylactic Treatment of Chemotherapy-Induced Thrombocytopenia in Non-Small Cell Lung Cancer. J Cancer. 2018 Nov 25;9(24):4718-4725. doi: 10.7150/jca.26690. eCollection 2018.

  PMID: 30588257 BACKGROUND

• Chen M, Li L, Xia Q, Chen X, Liao Z, Wang C, Shen B, Zhou M, Zhang Q, Zhang Y, Qian L, Yuan X, Wang Z, Xue C, An X, Liu B, Gu K, Hou M, Wang X, Wang W, Li E, Zhong J, Cheng J, Shu Y, Yang N, Wang H, Yang R, Liu T, Deng T, Ma F, Liao W, Qiu W, Chen Y, Chen X, Zhang M, Xu R, Li X, Feng J, Ba Y, Shi Y. A real-world observation on thrombopoietic agents for patients with cancer treatment-induced thrombocytopenia in China: A multicenter, cross-sectional study. Cancer. 2024 Apr 15;130(S8):1524-1538. doi: 10.1002/cncr.35292. Epub 2024 Mar 22.

  PMID: 38515388 BACKGROUND

• Bashour FN, Teran JC, Mullen KD. Prevalence of peripheral blood cytopenias (hypersplenism) in patients with nonalcoholic chronic liver disease. Am J Gastroenterol. 2000 Oct;95(10):2936-9. doi: 10.1111/j.1572-0241.2000.02325.x.

  PMID: 11051371 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Thrombocytopenia

Interventions

hetrombopag

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Central Study Contacts

Jian Zhang

CONTACT

+8618017312991; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Phase I Unit，Chief physician of oncology department

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 15, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share