- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03638648
Recurrence Score-guiding Chemotherapy in Non-pCR HR Positive HER2 Negative Breast Cancer After Neoadjuvant Therapy (RSBNAT)
September 6, 2019 updated by: Zhejiang Cancer Hospital
Multi Gene Detection Tool Based Recurrence Score-guiding Chemotherapy in Non-pathologic Complete Response HR Positive and HER2 Negative Breast Cancer After Neoadjuvant Treatment
The luminal subtype of breast cancer means hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+HER2-), which counted 60%-70% of breast cancer but achieve low pathologic complete response (pCR) rate (7.5%-15%) in neoadjuvant chemotherapy.
It is controversial whether additional chemotherapy after surgery is necessary for those non-pCR HR+HER2- patients.
Multiple gene is a mature diagnose tool for recurrence score in adjuvant treatment strategy.
This study is to investigating the value of multi gene detection tool based recurrence score for guiding additional chemotherapy after surgery in HR+HER2- non-pCR breast cancer.
Study Overview
Detailed Description
This study is designed as stratified cluster randomized, parallel-control research.
The HR+HER2- breast cancer patients after neoadjuvant chemotherapy (including anthracyclines and taxane, at least 6 cycles) assessed non-pCR are recruited, receiving multiple gene test before neoadjuvant treatment and after surgery.
After enrollment, the patients were stratified according to multiple gene test based recurrence risk level (High risk or Low risk) and then randomized into two groups respectively in each cluster: receiving additional chemotherapy (Capecitabine) group or negative control group.
The primary endpoint is 2-year disease free survival.
The second endpoint is 5-year disease free survival (DFS), 2-year overall survival (OS), 5-year OS, safety of additional chemotherapy.
The exploratory endpoint is the variety of multiple gene test based recurrence risk after neoadjuvant chemotherapy in non-pCR patients.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xingfei Yu, MD
- Phone Number: 8657188122001
- Email: yuxf1177@zjcc.org.cn
Study Contact Backup
- Name: Hongjian Yang, MM
- Phone Number: 8657188122001
- Email: yhjzlyy@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Invasive breast cancer at the first diagnosed
- Clinical stage cT1-4cN0-3M0 (AJCC 8th), receiving neoadjuvant chemotherapy at least 6 cycles
- Neoadjuvant chemotherapy regimen should include anthracyclines and taxane
- Primary tumor HR+(ER+ or PR+) and HER2 negative before neoadjuvant chemotherapy
- Pathological evaluation non-pCR after neoadjuvant chemotherapy (residual invasive cancer in primary tumor)
Exclusion Criteria:
- Metastasis, recurrent breast cancer or receiving other treatment before neoadjuvant chemotherapy
- Pregnant breast cancer
- IHC or FISH test of primary tumor confirmed HER2 positive at anytime
- Complete fewer than 6 cycles chemotherapy before surgery
- Deficiency of surgery after neoadjuvant
- Contraindication of chemotherapy or surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low risk Capecitabine
Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk receiving capecitabine.
|
Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles
Other Names:
|
No Intervention: Low risk control
Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk NOT receiving any additional chemotherapy.
|
|
Experimental: High risk Capecitabine
Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk receiving capecitabine.
|
Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles
Other Names:
|
No Intervention: High risk control
Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk NOT receiving any additional chemotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-year DFS
Time Frame: 2 years after randomized
|
disease-free survival rate in 2 years
|
2 years after randomized
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
5-year DFS
Time Frame: 5 years after randomized
|
disease-free survival rate in 5 years
|
5 years after randomized
|
2-year OS
Time Frame: 2 years after randomized
|
overall survival rate in 2 years
|
2 years after randomized
|
5-year OS
Time Frame: 5 years after randomized
|
overall survival rate in 5 years
|
5 years after randomized
|
Aside effect
Time Frame: 5 years
|
any aside effect induced by additional chemotherapy (Capecitabine)
|
5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
variety of multiple gene based recurrence score
Time Frame: half year after randomized
|
recurrence score before and after neoadjuvant chemotherapy
|
half year after randomized
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xingfei Yu, MD, Zhejiang Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2019
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
August 16, 2018
First Submitted That Met QC Criteria
August 16, 2018
First Posted (Actual)
August 20, 2018
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 6, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RS-NAT01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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