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NCT04941885: Increase

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

Status unknown Phase 2 Last updated 2 July 2021
What this trial tests

Phase 2 trial testing Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI in Breast Cancer in 78 participants. Status unknown.

Timeline
25 June 2021
Primary endpoint
1 July 2023
1 July 2025

Quick facts

Lead sponsorSun Yat-sen University
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment78
Start date25 June 2021
Primary completion1 July 2023
Estimated completion1 July 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. HER2-targeted therapies in cancer: a systematic review.
    Zhu K, Yang X, Tai H, Zhong X, et al · · 2024 · cited 83× · PMID 38308374 · DOI 10.1186/s40364-024-00565-1
  2. Metronomic Chemotherapy in Elderly Patients.
    Bandini A, Calabrò PF, Banchi M, Orlandi P, et al · · 2024 · cited 5× · PMID 38448722 · DOI 10.1007/s11912-024-01505-w
  3. Metronomic Chemotherapy in Breast Cancer: Unleashing the Potential of Combination Regimens.
    Liu J, Mo H, Li Q, Cazzaniga ME, et al · · 2025 · PMID 41221152 · DOI 10.1002/cai2.70035
  4. Endocrine therapy plus HER2-targeted therapy, another favorable option for HR+/HER2+ advanced breast cancer patients.
    Liang Y, Liu X, Yun Z, Li K, et al · · 2024 · PMID 38188468 · DOI 10.1177/17588359231220501

Verify or expand the search:

Other recruiting trials for Breast Cancer

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