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NCT04941885: Increase
Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer
Phase 2 trial testing Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI in Breast Cancer in 78 participants. Status unknown.
1 July 2023
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 25 June 2021 |
| Primary completion | 1 July 2023 |
| Estimated completion | 1 July 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT04941885
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Sun Yat-sen University trials
Trials by the same sponsor.
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- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04941885 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
- Last refreshed: 2 July 2021
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