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

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

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Capecitabine

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

Participation Criteria

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

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.	Drug: Capecitabine; Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles; Other Names: additional chemotherapy
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.	Drug: Capecitabine; Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles; Other Names: additional chemotherapy
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	disease-free survival rate in 2 years	2 years after randomized

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year DFS	disease-free survival rate in 5 years	5 years after randomized
2-year OS	overall survival rate in 2 years	2 years after randomized
5-year OS	overall survival rate in 5 years	5 years after randomized
Aside effect	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	recurrence score before and after neoadjuvant chemotherapy	half year after randomized

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Xingfei Yu, MD, Zhejiang Cancer Hospital

Study record dates

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

• Keywords: breast cancer; neoadjuvant; multiple gene detection
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• 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