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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03638648

RS-NAT01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Low risk Capecitabine

Active Comparator group

Description:

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

Treatment:

Drug: Capecitabine

Low risk control

No Intervention group

Description:

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

High risk Capecitabine

Experimental group

Description:

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

Treatment:

Drug: Capecitabine

High risk control

No Intervention group

Description:

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