Clinical trial NCT05555706: Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
Official title: A Phase II/III Study to Evaluate the Efficacy and Safety of B013 in Combination With Nab-Paclitaxel in First-line Treatment for Patients With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Triple Negative Breast Cancer (TNBC)
Lead sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Pharmaceuticals Holding Co., Ltd
First posted: 2022-09-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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 advanced or 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 Criteria:

1. Previous treatment is eligible.
2. Spinal cord compression not definitively treated with surgery and/or radiation prior to 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 cervix or Papillary carcinoma of the thyroid
7. Pregnancy or lactation

Primary outcomes:
measure: Objective response rate (ORR)(phase Ⅱ)
timeFrame: Baseline up to approximately 18 months
measure: Progression-free survival (PFS)(IRC) (phase Ⅲ)
timeFrame: Baseline up to approximately 18 months
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: 18 months
measure: Duration of remission (DOR)
timeFrame: 18 months
measure: Time to Response (TTR)
timeFrame: 18 months
measure: Overall Survival (OS)
timeFrame: 3years
measure: Drug concentration in plasma
timeFrame: 18 months
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 3years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital, Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Haikou
country: China
facility: Hainan cancer Hospital
state: Hainan
city: Luoyang
country: China
facility: The First Affiliated Hospital of henan University of Science and Technoloy
state: Henan
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Yongzhou
country: China
facility: The Central Hospital of Yongzhou
state: Hunan
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Neijiang
country: China
facility: The second people's hospital of neijiang
state: Sichuan
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Tianjin
country: China
facility: Tianjin medical university cancer institute&hospital
Study officials:
affiliation: Affiliated Cancer Hospital, Sun Yat-sen University
name: Shusen Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Huiping Li
role: PRINCIPAL_INVESTIGATOR
References: