Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer
Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer
This was an open-label, randomized controlled trial that aims to compare the efficacy and
 safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant
 chemotherapy alone in ER-positive, HER2-negative breast cancer.
Data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective
 option for ER-positive, HER2-negative breast cancer patients. However this is still a
 controversial issue. The present study is an open-label randomized controlled clinical trial
 that aims to investigate the efficacy of concurrent NCT with endocrine therapy (AI with or
 without GnRH-a) in patients with ER-positive, HER2-negative breast carcinoma.
Inclusion Criteria:

 1. Estrogen receptor-positive and HER2-negative breast cancer patients, with histological
 stage of IIa-IIIc.

 2. Without previous chemotherapy or endocrine therapy.

 3. ECOG scores of 0-2 points

 4. With measurable and evaluable breast tumor pathologically confirmed as invasive ductal
 carcinoma

 5. Age: 18-70 years

 6. Lateral breast cancer

 7. Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions

 Exclusion Criteria:

 1. Pregnant women or nursing mothers

 2. With distant metastasis

 3. With a history of malignant tumor or complicated with other malignant tumors in
 addition to breast cancer, except for non-melanoma skin cancer, in situ cervical
 cancer or other cured malignant tumor without the basis of recurrence for at least
 five years

 4. With mental illness or other conditions affecting the patient compliance

 5. With other serious diseases or medical conditions:

 1. Congestive heart failure or unstable angina pectoris, myocardial infarction
 within 6 months before the enrollment, uncontrolled hypertension and uncontrolled
 high-risk arrhythmia considered by the investigator

 2. Obvious neurological or psychiatric disorders, including psychosis, epileptic
 dementia and other diseases may affect the understanding and sign of the informed
 consent for

 3. Uncontrolled acute infection

 6. Concurrent use of other investigational drugs; or participating in other clinical
 trials involving investigational drugs within 30 days before this study

 7. With allergic constitution and any known or suspected drug allergy

 8. Not suitable for the trial considered by the investigator