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NCT Number: NCT02535221

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

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.

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Key information

Conditions

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

Age range

35 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital Breast Center

Beijing, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 35 years old <age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer
  • Stage: T2N0M0(cT>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
  • Histologically confirmed HR+ (ER or PR positive, and >50% cell in IHC) HER2 negative breast cancer by pathological evaluation
  • No other previous treatment for primary breast cancer
  • Without other tumor or unstable complication or uncontrolled infection
  • No contradiction for the third generation AIs, LHRHa, chemotherapy
  • Attend the study voluntarily, sign the informed consent.

Exclusion criteria

  • Metastasis disease by pathological or radiological diagnosis
  • the history of other tumor
  • contradiction for the third generation AIs, LHRHa, chemotherapy
  • Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy
  • Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
  • other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
  • have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study

Treatment and study plan

Goserelin+TAM+AI

Drug

Goserelin 3.6mg subcutaneous injection per 4 weeks, for 16-20weeks. TAM 10mg oral twice a day for the first four weeks(to wait the Goserelin start to work in body) than change to AI 1mg oral once a day with Goserelin for the next 12-16 weeks.

Other names: Endocrine therapy

Epirubicin+CTX+5-Fu

Drug

Epirubicin(80-100 mg/m2 Q21 days) + CTX(600 mg/m2 Q 21days) + 5-Fu (600 mg/m2 Q21 days or 200 mg/m2 •day from Day1 to day 21) for four to six cycles.

Other names: Chemotherapy

Primary outcomes

  1. ultrasound response rate

    Time frame: within 2 weeks before surgery

Secondary outcomes

  1. pathological response rate(Miller & Payne standard)

    Time frame: with 2 weeks after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Tao Ouyang, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2015
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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