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NCT04400695
A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2
Status unknown
Phase 3
Last updated 24 January 2024
What this trial tests
Phase 3 trial testing RC48-ADC in Breast Cancer in 366 participants. Status unknown.
Timeline
29 September 2020
Primary endpoint
30 June 2024
30 June 2024
30 December 2024
Quick facts
| Lead sponsor | RemeGen Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 366 |
| Start date | 29 September 2020 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- RC48-ADC — full drug profile →
- Paclitaxel Injection — full drug profile →
- Docetaxel Injection — full drug profile →
- Vinorelbine Tartrate Injection
- Capecitabine Tablets — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
RemeGen Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting HER2-positive breast cancer: advances and future directions.
Swain SM, Shastry M, Hamilton E. · · 2023 · cited 703× · PMID 36344672 · DOI 10.1038/s41573-022-00579-0 -
Emerging new therapeutic antibody derivatives for cancer treatment.
Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x -
Antibody-Drug Conjugates for Cancer Therapy.
Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764 -
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476 -
Targeting cancer with antibody-drug conjugates: Promises and challenges.
Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427 -
HER2 Low, Ultra-low, and Novel Complementary Biomarkers: Expanding the Spectrum of HER2 Positivity in Breast Cancer.
Venetis K, Crimini E, Sajjadi E, Corti C, et al · · 2022 · cited 99× · PMID 35372498 · DOI 10.3389/fmolb.2022.834651 -
Emerging Targeted Therapies for HER2-Positive Breast Cancer.
Mercogliano MF, Bruni S, Mauro FL, Schillaci R. · · 2023 · cited 95× · PMID 37046648 · DOI 10.3390/cancers15071987 -
Resistance to antibody-drug conjugates in breast cancer: mechanisms and solutions.
Chen YF, Xu YY, Shao ZM, Yu KD. · · 2023 · cited 93× · PMID 36357174 · DOI 10.1002/cac2.12387
Verify or expand the search:
- PubMed search for NCT04400695
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of RC48-ADC
Trials testing the same drug.
- NCT06074484 — A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer · Phase 2 · unknown
- NCT06178601 — A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic U · Phase 2 · unknown
- NCT05514158 — To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 · Phase 1 · unknown
- NCT05302284 — A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma · Phase 3 · recruiting
- NCT05297552 — A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer · Phase 2 · unknown
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other RemeGen Co., Ltd. trials
Trials by the same sponsor.
- NCT07537881 — A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors · Phase 1, PHASE2 · not yet recruiting
- NCT07462143 — A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer · Phase 2, PHASE3 · not yet recruiting
- NCT07495033 — Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related I · Phase 3 · not yet recruiting
- NCT07416474 — RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Smal · Phase 3 · not yet recruiting
- NCT07249632 — A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG) · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04400695 (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 RemeGen Co., Ltd.
- Last refreshed: 24 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04400695.
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