Clinical Study of Adjuvant Therapy on Post-menopausal Women With Breast Cancer Under the Guidance of the Results of Preoperative Endocrinotherapy

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a phase II, prospective, multi-center, open-label, non-randomized, controlled study. The objective of this study is to prospectively verify the relation of efficacy of neoadjuvant hormonal therapy, and preliminarily explore the clinical value of complementary adjuvant chemotherapy to predict poor prognosis malignant breast cancer after neoadjuvant endocrinotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tao OUYANG

Criteria

Inclusion Criteria:

• Female, not more than 75 years old, judged to have been in menopause by the investigator when enrolled. Refer to the following criteria to determine whether they are postmenopausal breast cancer.

• Spontaneous amenorrhea for more than 12 months Age ≥ 60 Age < 60, but FSH and E2 reach postmenopausal level.

• Received bilateral ovariectomy previously

• Not to define the women using LHRH agonists or antagonists as in postmenopausal state.

• Evidence of primary invasive breast cancer is confirmed by histopathological diagnosis.

• Clinical stage is T2-3N0M0

• ER or PgR are expressed in more than 50 percent of tumour cells, and HER2 is negative.

• No abnormal axillary nodes in ultrasound examination; no evidence of cancer metastasis confirmed by abnormal lymph node puncture pathological examination

• With plan of receiving simple endocrinotherapy and avoiding adjuvant chemotherapy

• No previous breast cancer treatment history

• No other tumors previously; no unstable complications or uncontrolled infection.

• No contraindication for endocrinotherapy with 3rd generation of aromatase inhibitors

• Participate in the trial voluntarily and sign the informed consent form.

Exclusion Criteria:

• Evidence of distant breast cancer metastasis by pathological and imaging diagnosis

• Patients who have a history of other malignant tumors

• With contraindications for 3rd generation of aromatase inhibitors

• Physical condition can not bear the experiment

• Patients who have potential mental, psychological, familial, social, geographic, or other factors that can hinder study regime performance.

• Patients who were treated or are treated with other anti-tumor measures before or during this trial, or planed to participate in other clinical trials.

• Patients who refuse to participate in the trial.