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

NCT03638648 | Unknown Phase 2 DMC

• 1 other identifier: RS-NAT01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

breast cancer; neoadjuvant; multiple gene detection

Outcome Measures

Primary Outcomes (1)

• 2-year DFS

  disease-free survival rate in 2 years

  2 years after randomized

Secondary Outcomes (4)

• 5-year DFS

  5 years after randomized

• 2-year OS

  2 years after randomized

• 5-year OS

  5 years after randomized

• Aside effect

  5 years

Other Outcomes (1)

• variety of multiple gene based recurrence score

  half year after randomized

Study Arms (4)

Low risk Capecitabine

ACTIVE COMPARATOR

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

Drug: Capecitabine

Low risk control

NO INTERVENTION

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

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

Drug: Capecitabine

High risk control

NO INTERVENTION

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

Interventions

Capecitabine DRUG

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

Also known as: additional chemotherapy

High risk Capecitabine; Low risk Capecitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xingfei Yu, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingfei Yu, MD

CONTACT

8657188122001; yuxf1177@zjcc.org.cn

Hongjian Yang, MM

CONTACT

8657188122001; yhjzlyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: November 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2022
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share