NCT05749016

Brief Summary

Inetetamab (Cipterbin) is a newly marketed anti-HER2 monoclonal antibody with amino acid modified Fc region and enhanced antibody-dependent cellular cytotoxicity (ADCC) effect. There was no robust evidence evaluating the combination of inetetamab with pertuzumab and neoadjuvant chemotherapy (paclitaxel + carboplatin) in the neoadjuvant setting. This study aimed to evaluate the efficacy and safety of inetetamab + pertuzumab+paclitaxel + carboplatin (TCbIP) as a neoadjuvant chemotherapy regimen in the treatment of patients with locally advanced HER2-positive breast cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

February 18, 2023

Last Update Submit

February 28, 2023

Conditions

Locally Advanced Breast CancerChemotherapy Effect

Keywords

Locally Advanced Breast CancerNeoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • pathologic complete response (pCR) rate

    Proportion of patients with no residual invasive tumor cells on pathological examination of primary breast lesions and axillary lymph node surgical specimens of all patients

    up to 6 months

Secondary Outcomes (1)

  • near pathologic complete response

    up to 6 months

Study Arms (1)

Study group

EXPERIMENTAL

Eligible patients received inetetamab with pertuzumab and paclitaxel/carboplatin (TCbIP) regimen every three weeks for a maximum of 6 cycles, followed by surgery.

Drug: inetetamab with pertuzumab and paclitaxel/carboplatin (TCbIP) regimen

Interventions

inetetamab with pertuzumab and paclitaxel/carboplatin (TCbIP) regimenDRUG

Inetetamab (Cipterbin) is a newly marketed anti-HER2 monoclonal antibody with amino acid modified Fc region and enhanced antibody-dependent cellular cytotoxicity (ADCC) effect. There was no robust evidence evaluating the combination of inetetamab with pertuzumab and neoadjuvant chemotherapy (paclitaxel + carboplatin) in the neoadjuvant setting. This study aimed to evaluate the efficacy and safety of inetetamab + pertuzumab+paclitaxel + carboplatin (TCbIP) as a neoadjuvant chemotherapy regimen in the treatment of patients with locally advanced HER2-positive breast cancer.

Also known as: Cipterbin with pertuzumab and paclitaxel/carboplatin (TCbIP) regimen
Study group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of minimum of 18 years to a maximum of 70 years; males or females
  • diagnosed as invasive breast carcinoma by preoperative needle core biopsy; patients with clinical stage of T1c to T4, N0-3, and M0, as defined by the American Joint Committee on Cancer AJCC Staging Manual, 8th Edition staging criteria
  • HER2-positive: an immunohistochemistry (IHC) score of 3+ or IHC 2+ and in situ hybridization ISH+/fluorescence in situ hybridization FISH+.
  • Left ventricular ejection fraction (LVEF) ≥50%；
  • Eastern Cooperative Oncology Group (ECOG) performance score was 0/1；
  • In the absence of blood transfusion or pharmacological treatment (granulocyte colony-stimulating factor/erythropoietin (EPO)/interleukin-11, etc.) within 14 days prior to the first treatment, and organ function must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×109/L; platelets (PLT) ≥ 100×109/L; hemoglobin (Hb) ≥ 90g/L. Blood biochemistry: total bilirubin (TBIL) ≤1.5×ULN; ALT and AST ≤1.5×ULN; BUN and Cr ≤1.5×ULN; creatinine clearance ≥50mL/min (Cockcroft-Gault formula); total bilirubin (TBIL) ≤1.5×ULN; ALT and AST ≤1.5×ULN; BUN and Cr ≤1.5×ULN; creatinine clearance ≥50mL/min (Cockcroft-Gault formula);
  • Volunteered to participate in this study and signed informed consent.

You may not qualify if:

  • had a previous history of invasive breast cancer;
  • Bilateral breast cancer, inflammatory breast cancer (eg, erythema and/or skin involvement, and/or pathological findings of neoplastic cells in dermal lymphatic vessels);
  • Previous excisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes;
  • Previous systemic therapy for breast cancer；
  • History of previous life-threatening hypersensitivity reactions, or known hypersensitivity to any component of the study drug；
  • Participated in clinical trials of other drugs or medical devices within 4 weeks before the first medication, and received treatment with experimental drugs or devices；
  • Patients who have undergone major surgery within 28 days before the first dose, or plan to have major surgery during the study period；
  • Other malignancies within the past 5 years (except cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ)；
  • Active hepatitis, active tuberculosis or other serious infectious diseases, etc., including but not limited to: active hepatitis C virus (HCV) infection (except for HCV antibody positive but RNA negative), or active hepatitis B virus (HBV) infection (hepatitis B Surface antigen positive and HBV-DNA copy number \>2000 IU/mL) or bacteremia, severe infectious pneumonia and other serious infections requiring systemic treatment
  • History of immunodeficiency or other autoimmune diseases, including but not limited to human immunodeficiency virus (HIV) infection (HIV antibody positive), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation；
  • Those with the following history of cardiovascular and cerebrovascular diseases, including: (1) unstable angina; (2) arrhythmia requiring drug treatment or clinically significant; (3) myocardial infarction within 6 months; (4) cardiac arrhythmia Failure, second-degree and above atrioventricular block; (5) cerebral infarction (except lacunar infarction), cerebral hemorrhage and other diseases within 6 months；
  • Patients with poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg under regular drug control), or a history of hypertensive crisis or hypertensive encephalopathy；
  • Pregnant and breastfeeding female patients; women of childbearing age who have a positive pregnancy test during the screening period; patients who are unwilling to take effective contraceptive measures during the entire test period and within 6 months after the end of the medication；
  • Other conditions that the investigator considers inappropriate to participate in this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Beijing, China

RECRUITING

Related Publications (1)

  • Jiang M, Chai Y, Liu J, He M, Wang Y, Yang X, Xing Z, Zhang M, Zhou S, Ma F, Wang J, Yuan P, Xu B, Li Q. Neoadjuvant inetetamab and pertuzumab with taxanes and carboplatin (TCbIP) In locally advanced HER2-positive breast cancer: a prospective cohort study with propensity-matched analysis. BMC Cancer. 2024 Jul 22;24(1):877. doi: 10.1186/s12885-024-12654-3.

    PMID: 39039516DERIVED

MeSH Terms

Interventions

pertuzumabPaclitaxelCarboplatinClinical Protocols

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesTherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Binghe Xu, Dr.

    National Cancer Center/National Clinical Research Center for Cancer

    STUDY DIRECTOR

Central Study Contacts

Qiao Li, Dr.

CONTACT

15910573527liqiaopumc@qq.com

Yue Chai, Dr.

CONTACT

13350804092cy972628990@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The phase II trial included patients with histologically confirmed stage IIA to IIIC and HER2-positive primary invasive breast cancer from November 2021 to July 2023. Eligible patients received inetetamab with pertuzumab and paclitaxel/carboplatin (TCbIP) regimen every three weeks for a maximum of 6 cycles, followed by surgery. The primary endpoint was pathologic complete response (pCR; ypT0 ypN0) rate. Key secondary endpoints included near pCR (npCR) (residual breast disease \<1cm), objective response rate (ORR) and safety.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 1, 2023

Study Start

November 1, 2021

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Individual anonymized participant data will not be shared.

Locations

CN(1)