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Triple Negative Breast Cancer (TNBC)Phase 2/3NCT05555706

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

A Phase 2/3 study testing B013+Nab-Paclitaxel in people with Triple Negative Breast Cancer (TNBC), run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Triple Negative Breast Cancer (TNBC)
What is being tested?
B013+Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
13 sitesChina
Study dates
6 Dec 2022to 30 Sep 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women or men aged 18 -75 years
  • Locally advanced or metastatic triple negative breast cancer (TNBC)
  • No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
  • ECOG performance status of 0 or 1
  • Patient must have measurable or evaluable disease as defined by RECIST v1.1. Measurable lesions will be confirmed by radiographic imaging (CT or MRI)

Who cannot join

  • Previous treatment is eligible.
  • Spinal cord compression not definitively treated with surgery and/or radiation prior to study entry
  • Known central nervous system (CNS) disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites Patients
  • Uncontrolled tumor-related pain prior to study entry
  • 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
  • Pregnancy or lactation

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Peking University Cancer Hospital

    Beijing, 100142

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

  • Affiliated Cancer Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

  • Hainan cancer Hospital

    Haikou, Hainan, 570312

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223300

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

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

    Luoyang, Henan, 450062

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

  • The second people's hospital of neijiang

    Neijiang, Sichuan, 641199

  • Tianjin medical university cancer institute&hospital

    Tianjin, 300060

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan, 425002

Other trials in China

About this study

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

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).

Being tested
B013+Nab-Paclitaxel
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B013+Nab-PaclitaxelDrug

    B013 at a fixed dose of 600 milligrams via intravenous (IV) infusion on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.

    Nab-Paclitaxel 100 mg/m^2 is administered weekly on Days 1, 8, 15 of each 28-day cycle.

Study groups in NCT05555706
Study groupRoleWhat they receive
B013+ Nab-PaclitaxelExperimentalB013 at a fixed dose of 600 milligrams via intravenous (IV) infusion on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle. Nab-Paclitaxel 100 mg/m^2 is administered weekly on Days 1, 8, 15 of each 28-day cycle.
Receives: Drug: B013+Nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)(phase Ⅱ)

    tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

    Measured: Baseline up to approximately 18 months

  2. Progression-free survival (PFS)(IRC) (phase Ⅲ)

    from the start date of study treatment to the date of progression disease or death , whichever occurred first.

    Measured: Baseline up to approximately 18 months

Secondary outcomes (6)

  1. Disease control rate (DCR)

    DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease

    Measured: 18 months

  2. Duration of remission (DOR)

    DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause

    Measured: 18 months

  3. Time to Response (TTR)

    Defined as the interval from the start of study therapy to the first documentation of an objective response

    Measured: 18 months

  4. Overall Survival (OS)

    Determination of the overall survival times of all patients

    Measured: 3years

  5. Drug concentration in plasma

    Determination of drug concentration in plasma of all patients

    Measured: 18 months

  6. Incidence of Treatment-Emergent Adverse Events

    Adverse event type, incidence, duration, correlation with study drug

    Measured: 3years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2022
  2. Study start6 Dec 2022
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05555706
Sponsor's protocol ID
B013-301
Status last verified
Jan 2025
First submitted
22 Sep 2022
Last updated
15 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing B013+Nab-Paclitaxel in people with Triple Negative Breast Cancer (TNBC), run by Shanghai Jiaolian Drug Research and Development Co., Ltd at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR)(phase Ⅱ) (time frame: Baseline up to approximately 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05555706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.

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