Actively Recruiting

Phase 3
Age: 35Years - 55Years
FEMALE
NCT02535221

Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

Led by Peking University · Updated on 2021-11-29

234

Participants Needed

1

Research Sites

596 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.

CONDITIONS

Official Title

Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

Who Can Participate

Age: 35Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 35 to 55 years, premenopausal as judged by researchers at recruitment
  • Histologically confirmed primary invasive breast cancer
  • Stage T2N0M0 with tumor size greater than 2cm and negative sentinel lymph node biopsy
  • Breast conserving surgery not feasible or may affect breast appearance
  • Hormone receptor-positive (ER or PR positive, >50% cells by IHC) and HER2 negative breast cancer
  • No previous treatment for primary breast cancer
  • No other tumors or unstable complications or uncontrolled infections
  • No contraindications for third generation aromatase inhibitors, LHRHa, or chemotherapy
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Metastatic disease diagnosed pathologically or radiologically
  • History of other tumors
  • Contraindications for third generation aromatase inhibitors, LHRHa, or chemotherapy
  • Serious heart, cerebral vessel disease, liver or kidney dysfunction, blood disorders, or other conditions making chemotherapy unsuitable
  • Contraindications for surgery such as anesthesia issues, large lesions, T4 stage, or lymph node positivity
  • Psychological, mental, social, or geographic problems preventing participation
  • Participation in other anti-tumor treatments or clinical trials
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Cancer Hospital Breast Center

Beijing, China

Actively Recruiting

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Research Team

T

Tao Ouyang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer | DecenTrialz