Recurrence Score-guiding Chemotherapy in Non-pCR HR Positive HER2 Negative Breast Cancer After Neoadjuvant Therapy

Breast Cancer Clinical Trial

— RSBNAT  

Official title:

Multi Gene Detection Tool Based Recurrence Score-guiding Chemotherapy in Non-pathologic Complete Response HR Positive and HER2 Negative Breast Cancer After Neoadjuvant Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03638648
• Other study ID #: RS-NAT01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2019
• Source: Zhejiang Cancer Hospital
• Contact: Xingfei Yu, MD
• Phone: 8657188122001
• Email: yuxf1177[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Invasive breast cancer at the first diagnosed

2. Clinical stage cT1-4cN0-3M0 (AJCC 8th), receiving neoadjuvant chemotherapy at least 6 cycles

3. Neoadjuvant chemotherapy regimen should include anthracyclines and taxane

4. Primary tumor HR+(ER+ or PR+) and HER2 negative before neoadjuvant chemotherapy

5. Pathological evaluation non-pCR after neoadjuvant chemotherapy (residual invasive cancer in primary tumor)

Exclusion Criteria:

1. Metastasis, recurrent breast cancer or receiving other treatment before neoadjuvant chemotherapy

2. Pregnant breast cancer

3. IHC or FISH test of primary tumor confirmed HER2 positive at anytime

4. Complete fewer than 6 cycles chemotherapy before surgery

5. Deficiency of surgery after neoadjuvant

6. Contraindication of chemotherapy or surgery

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Intervention

Drug:
• Capecitabine
Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	variety of multiple gene based recurrence score	recurrence score before and after neoadjuvant chemotherapy	half year after randomized
Primary	2-year DFS	disease-free survival rate in 2 years	2 years after randomized
Secondary	5-year DFS	disease-free survival rate in 5 years	5 years after randomized
Secondary	2-year OS	overall survival rate in 2 years	2 years after randomized
Secondary	5-year OS	overall survival rate in 5 years	5 years after randomized
Secondary	Aside effect	any aside effect induced by additional chemotherapy (Capecitabine)	5 years