Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
1 other identifier
interventional
30
1 country
1
Brief Summary
This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 breast-cancer
Started Aug 2021
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2021
CompletedFirst Posted
Study publicly available on registry
May 11, 2021
CompletedStudy Start
First participant enrolled
August 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2023
CompletedJune 22, 2022
June 1, 2022
1.3 years
May 6, 2021
June 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
tp CR as assessed by local pathologist
total pathological complete response as assessed by local pathologist
up to 12 weeks
Secondary Outcomes (3)
bp CR as assessed by local pathologist
up to 12 weeks
ORR as assessed by the investigator according to RECIST 1.1
up to 12 weeks
safety as assessed by the investigator according to RECIST 1.1
up to 12 weeks
Study Arms (1)
KN026 + Docetaxel
EXPERIMENTALKN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subject \>= 18 years;
- Histologically or cytologically confirmed HER2-positive breast cancer defined as 3+ determined by validated IHC or positive by in situ hybridization (ISH);
- Early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) breast cancer;
- Adequate organ function assessed within 7 days prior to first trial treatment;
- ECOG score 0 or 1;
- Left ventricular ejection fraction (LVEF) ≥ 55% at baseline;
You may not qualify if:
- Stage IV (metastatic) breast cancer;
- Inflammatory breast cancer;
- Previous anti-cancer therapy or radiotherapy for any malignancy;
- Major surgery for any reason within 28 days;
- History of uncontrolled intercurrent illness;
- Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiong Wu, professor
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2021
First Posted
May 11, 2021
Study Start
August 9, 2021
Primary Completion
November 15, 2022
Study Completion
February 15, 2023
Last Updated
June 22, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share