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

NCT04941885 | Unknown Phase 2

• 1 other identifier: SYSU-2021
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The proportion of best overall response of either complete or partial response.

  1 year

Secondary Outcomes (6)

• Clinical benefit rate (CBR)

  1 year

• Progression free survival (PFS)

  1 year

• Duration of response (DOR)

  1 year

• Overall survival (OS)

  3 years

• Number of Participants with Adverse Events

  1 year

Study Arms (1)

Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI

EXPERIMENTAL

Each participant receives Inetetamab(8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days) plus cyclophosphamide metronomic chemotherapy(50mg once a day orally) plus aromatase(once a day orally).

Drug: Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI

Interventions

Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI DRUG

Each participant receives Inetetamab plus cyclophosphamide metronomic chemotherapy plus AI.

Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form;
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Shusen Wang

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shusen Wang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shusen Wang, MD

CONTACT

+86-13926168469; wangshs@sysucc.org.cn

Kuikui Jiang, MD

CONTACT

+86-15210589011; jiangkk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: June 28, 2021
• Study Start: June 25, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: July 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)