Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    78
  • sponsor
    Sun Yat-sen University
Updated on 7 July 2021
cyclophosphamide
estrogen
measurable disease
carcinoma
metastasis
HER2
trastuzumab
erbb2
aromatase inhibitor
estrogen receptor
invasive carcinoma

Summary

Antibody-dependent cell-mediated cytotoxicity (ADCC) is one of the important mechanisms for suppressing tumors of Trastuzumab. Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a modified Fc segment, is 1.11 times that of trastuzumab. Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits. Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies. Therefore, we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients and to explore the possible mechanisms.

Description

Trastuzumab is a humanized monoclonal antibody, and antibody-dependent cell-mediated cytotoxicity (ADCC) is one of its important mechanisms for suppressing tumors. Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a modified Fc segment, is 1.11 times that of trastuzumab. Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits, but the absolute benefits are still unsatisfactory. Further improvement of ADCC effects and monoclonal antibody-induced immune responses may improve the clinical benefits. Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies. According to previous clinical studies, for HR-positive and HER2-positive metastatic breast cancer patients, metronomic chemotherapy combined with endocrine therapy and anti-HER2 targeted therapy may be one of the treatment options. Therefore, we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients, and we further exploring the possible mechanisms.

Details
Condition Breast Cancer Diagnosis, Breast Cancer, breast carcinoma, cancer, breast
Treatment Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI
Clinical Study IdentifierNCT04941885
SponsorSun Yat-sen University
Last Modified on7 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Voluntarily sign the informed consent form
18-75 years old
The expected survival period is 12 weeks
Eastern Cooperative Oncology Group (ECOG) score [0-2] points
The diagnosis of invasive carcinoma by histology or cytology; Estrogen receptor (ER) positive (defined as >1% nuclear ER staining); HER2 negative (defined as IHC 0 or 1+, or HER2(2+) with HER2 FISH detection no amplification)
Inoperable or recurrent/metastatic breast cancer patients with aromatase inhibitor treatment failure
In the state of disease progression before enrollment
Measurable disease according to RECIST version 1.1 or only bone metastasis
Adequate hematological, hepatic and renal function
NYHA class I or II and Left ventricular ejection fraction (LVEF) 50%
The diagnosis of invasive carcinoma by histology or cytology: Hormone receptor (HR) positive (defined as >1% nuclear estrogen receptor staining); HER2 positive (defined as IHC 3+, or HER2 FISH detection amplification)
In the state of disease progression before enrollment
Have lesions able to and agree to perform tissue biopsy at the time requested in the study
Treatment 1 line after recurrence/metastasis, or relapse within 12 months after completing trastuzumab-based adjuvant therapy or during trastuzumab adjuvant therapy
Previously received trastuzumab for anti-HER2 therapy
Measurable disease according to RECIST version 1.1

Exclusion Criteria

Allergic to the ingredients of Inetetamab, cyclophosphamide or similar drugs
Concomitant diseases/conditions that is not controllable, and any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study
Patients who cannot accept drugs orally
Women who are pregnant or breastfeeding or planning to give birth
Patients with currently symptomatic brain or meningeal metastasis
History of other primary malignancy
Resistant to steroidal or nonsteroidal aromatase Inhibitor
Have used Inetetamab
Patients with life-threatening, symptomatic, metastatic visceral disease
Clear my responses

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