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

NCT ID: NCT03638648

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2022-12-30

Brief 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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low risk Capecitabine

Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk receiving capecitabine.

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

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

Low risk control

Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk NOT receiving any additional chemotherapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

High risk Capecitabine

Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk receiving capecitabine.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

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

High risk control

Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk NOT receiving any additional chemotherapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Capecitabine

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

Intervention Type: DRUG

Other Intervention Names

additional chemotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xingfei Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Central Contacts

Xingfei Yu, MD

Role: CONTACT

yuxf1177@zjcc.org.cn

8657188122001

Hongjian Yang, MM

Role: CONTACT

yhjzlyy@163.com

8657188122001

Other Identifiers

RS-NAT01

Identifier Type: -

Identifier Source: org_study_id