deltatrials
Unknown PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT03500380

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

A Randomized, Controlled, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Breast Cancer and Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Advanced Breast With Liver Metastases

Sponsor: RemeGen Co., Ltd.

Conditions Breast Diseases Breast Neoplasms Capecitabine HER2 Positive Breast Carcinoma HER2-positive Advanced Breast With Liver Metastases HER2-positive Breast Cancer
Interventions Capecitabine Lapatinib RC48-ADC
Updated 14 times since 2018 Last updated: Feb 18, 2024 Started: Apr 24, 2018 Primary completion: Jul 31, 2024 Completion: Dec 31, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2/PHASE3 clinical study on Breast Diseases and Breast Neoplasms, this trial is ongoing. The trial is conducted by RemeGen Co., Ltd. and has accumulated 14 data snapshots since 2018. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jun 2019 · 12 months · monthly snapshot~Jun 2019 – ~Feb 2020 · 8 months · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Mar 2022 · 6 months · monthly snapshot~Mar 2022 – ~Dec 2023 · 21 months · monthly snapshot~Dec 2023 – ~Mar 2024 · 3 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Jan 2026 · 4 months · monthly snapshot~Jan 2026 – present · 6 months · monthly snapshot

Change History

14 versions recorded

  1. Jan 2026 — Present [monthly]

    Unknown PHASE2/PHASE3

    Status: Active Not Recruiting → Unknown

  2. Sep 2025 — Jan 2026 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

  5. Mar 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE2_PHASE3

▶ Show 9 earlier versions

  1. Dec 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Recruiting → Active Not Recruiting

  2. Mar 2022 — Dec 2023 [monthly]

    Recruiting PHASE2_PHASE3

  3. Sep 2021 — Mar 2022 [monthly]

    Recruiting PHASE2_PHASE3

    Phase: PHASE2 → PHASE2_PHASE3

  4. Apr 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  5. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  6. Feb 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  7. Jun 2019 — Feb 2020 [monthly]

    Recruiting PHASE2

  8. Jun 2018 — Jun 2019 [monthly]

    Recruiting PHASE2

  9. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE2

    First recorded

Apr 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • RemeGen Co., Ltd.
Data source: RemeGen Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Anyang, China , Beijing, China , Bengbu, China , Binzhou, China , Changchun, China , Changsha, China , Changzhi, China , Chengde, China , Chengdu, China , Chongqing, China and 35 more locations