RecruitingPhase II/IIIFemale onlyEN original

A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 with or without Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjentki wyrażają zgodę na udział i stosują się do zasad badania.
  • Kobiety w wieku 18-75 lat.
  • Pacjentki z potwierdzonym histopatologicznie HER2-dodatnim rakiem piersi.
  • Rak jest we wczesnym stadium (II-III) przed leczeniem.
  • Pacjentki nie były wcześniej leczone na raka piersi.
  • Pacjentki zgadzają się na operację (mastektomię lub operację oszczędzającą pierś) po leczeniu.
  • Dobra ogólna kondycja fizyczna (parametr ECOG 0 lub 1).
  • Kobiety w wieku rozrodczym muszą stosować skuteczną antykoncepcję.

✗ Disqualifies

  • Rak piersi w stadium rozsianym (IV).
  • Rak obu piersi.
  • Wcześniejsza historia choroby nowotworowej piersi (z wyjątkiem niektórych łagodnych zmian).
  • Inne poważne choroby serca lub naczyń mózgowych w ostatnim czasie.
  • Problemy z rytmem serca lub wysokie ciśnienie krwi.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
October 2, 2025
Sex
Female only

Therapies / drugs in trial

Locations (30)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Anhui Provincial Cancer Hospital

Hefei, China

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Fujian Medical University Union Hospital

Fuzhou, China

Guangdong Maternal and Child Health Center

Guangzhou, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, China

Liuzhou People's Hospital

Liuzhou, China

Guangxi Medical University Cancer Hospital

Nanning, China

Hainan General Hospital

Haikou, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

Xingtai People's Hospital

Xingtai, China

Harbin Medical University Cancer Hospital

Harbin, China

Anyang Cancer Hospital

Anyang, China

The First Affiliated Hospital of Henan University of science and technology

Luoyang, China

Henan Provincial People's Hospital

Zhengzhou, China

Hunan Cancer Hospital

Changsha, China

The Second Xiangya Hospital of Central South University

Changsha, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Shaanxi Provincial People's Hospital

Xi'an, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Shandong Cancer Hospital

Jinan, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanxi Bethune Hospital

Taiyuan, China

Shanxi Cancer Hospital

Taiyuan, China

Sichuan Cancer Hospital

Chengdu, China

Tianjin Cancer Hospital

Tianjin, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.