Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer

Last updated: April 14, 2025
Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Overall Status: Completed

Phase

2/3

Condition

N/A

Treatment

B013+Nab-Paclitaxel

Clinical Study ID

NCT05555706
B013-301
  • Ages 18-75
  • All Genders

Study Summary

This Phase II/III study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of B013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women or men aged 18 -75 years

  2. Locally advanced or metastatic triple negative breast cancer (TNBC)

  3. No prior chemotherapy or targeted systemic therapy for inoperable locally advancedor metastatic TNBC

  4. ECOG performance status of 0 or 1

  5. Patient must have measurable or evaluable disease as defined by RECIST v1.1.Measurable lesions will be confirmed by radiographic imaging (CT or MRI)

Exclusion

Exclusion Criteria:

  1. Previous treatment is eligible.

  2. Spinal cord compression not definitively treated with surgery and/or radiation priorto study entry

  3. Known central nervous system (CNS) disease

  4. Uncontrolled pleural effusion, pericardial effusion, or ascites Patients

  5. Uncontrolled tumor-related pain prior to study entry

  6. The patient has a history of another malignancy within 5 years prior to study entry,except adequately treated non-melanotic skin cancer, carcinoma in situ of the cervixor Papillary carcinoma of the thyroid

  7. Pregnancy or lactation

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: B013+Nab-Paclitaxel
Phase: 2/3
Study Start date:
December 06, 2022
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • Affiliated Cancer Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Hainan cancer Hospital

    Haikou, Hainan 570312
    China

    Site Not Available

  • The First Affiliated Hospital of henan University of Science and Technoloy

    Luoyang, Henan 450062
    China

    Site Not Available

  • Xiangyang Central Hospital

    Xiangyang, Hubei 441021
    China

    Site Not Available

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan 425002
    China

    Site Not Available

  • Huai'an First People's Hospital

    Huai'an, Jiangsu 223300
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • The second people's hospital of neijiang

    Neijiang, Sichuan 641199
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming, Yunnan 650118
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310005
    China

    Site Not Available

  • Peking University Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • Tianjin medical university cancer institute&hospital

    Tianjin, 300060
    China

    Site Not Available

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