NCT06278870

Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial

Recruiting now Phase 3 Last updated 26 February 2024

What this trial tests

Phase 3 trial testing disitamab vedotin in HER2-positive Metastatic Breast Cancer in 312 participants. Currently enrolling.

Timeline

6 September 2023

Primary endpoint
30 June 2031

30 June 2031

Quick facts

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	312
Start date	6 September 2023
Primary completion	30 June 2031
Estimated completion	30 June 2031
Sites	1 location across China

Drugs / interventions tested

• disitamab vedotin (disitamab-vedotin) — full drug profile →
• Pyrotinib — full drug profile →
• trastuzumab (trastuzumab) — full drug profile →
• Pertuzumab (pertuzumab) — full drug profile →
• taxane drug

Conditions studied

• HER2-positive Metastatic Breast Cancer — all drugs for HER2-positive Metastatic Breast Cancer →
• First-line Treatment — all drugs for First-line Treatment →

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

Adults 18 to 75, female only, with HER2-positive Metastatic Breast Cancer or First-line Treatment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are:

* Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP.
* Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment.

Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab.

Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer.

Publications & conference data

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

1. Docetaxel Resistance in Breast Cancer: Current Insights and Future Directions.
   Postigo-Corrales F, Beltrán-Videla A, Lázaro-Sánchez AD, Hurtado AM, et al · · 2025 · cited 5× · PMID 40806254 · DOI 10.3390/ijms26157119
2. Antibody-drug conjugates in breast cancer: mechanisms of resistance and future therapeutic perspectives.
   Valle I, Grinda T, Antonuzzo L, Pistilli B. · · 2025 · cited 3× · PMID 41022825 · DOI 10.1038/s41523-025-00829-5
3. Advances in the study of pyrotinib for the treatment of HER2-positive breast cancer.
   Li Y, Wang W, Liang Y, Lai H, et al · · 2026 · PMID 41776549 · DOI 10.1186/s13058-026-02255-2
4. Breast Cancer: Molecular Pathogenesis, Targeted Therapy, Screening, and Prevention.
   Lei H, Fu J, Gu W, Qiao H, et al · · 2026 · PMID 41510186 · DOI 10.1002/mco2.70560
5. Pyrotinib and Nab-Paclitaxel in HER2-Positive Breast Cancer (PANHER Trial): A Prospective, Single-Arm, Phase II Trial.
   Li H, Yan M, Li Z, Cui X, et al · · 2025 · PMID 40263948 · DOI 10.1111/cas.70086
6. Recent advances of antibody-drug conjugates in treating breast cancer with different HER2 status.
   Qiu Y, Shi Y, Chao Z, Zhu X, et al · · 2025 · PMID 39759831 · DOI 10.1177/17588359241311379