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

Phase 2
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

In the decision-making process of a systemic adjuvant therapy for ER-positive/HER2-negative
breast cancer, to avoid adjuvant chemotherapy is an attractive but hard choice. On one hand,
the result of tamoxifen endocrine therapy combined with adjuvant chemotherapy is superior to
tamoxifen endocrine therapy alone for ER-positive breast cancer patients; on the other hand,
the benefit that adjuvant chemotherapy provides to breast cancer with high hormone receptor
expression is not clear and the tolerance of chemotherapy is much lower than that of

St. Galen consensus on adjuvant therapy for early breast cancer recommends adopting simple
endocrinotherapy and avoiding adjuvant chemotherapy for medium- and low- risk breast cancer
with hormone receptor highly expressed. However, the results of study P024 and IMPACT
suggest that hormone receptor expression is insufficient to predict the effect of

At present, the proven clinical value of neoadjuvant endocrinotherapy is to assist surgery.
Consensus recommends neoadjuvant endocrinotherapy for the patients with postmenopausal
breast cancer who plan to receive simple adjuvant endocrinotherapy. The current study
results show that neoadjuvant endocrinotherapy may be used as an experimental treatment
platform, i.e., it can predict the results of adjuvant endocrinotherapy through
comprehensive analysis of multiple indexes of the surgery samples after neoadjuvant

By using P024 and IMPACT samples, Ellis et al studied the relation between survival and the
test results of surgery samples after neoadjuvant endocrinotherapy, and obtained PEPI (the
preoperative endocrine prognostic index). They have preliminarily proved that the PEPI score
is relative to RFS (relapse-free survival) of postmenopausal ER-positive breast cancer
treated with simple endocrinotherapy and to BCSS (breast cancer-specific survival).

A retrospective study,performed by breast prevention and treatment center in Peking
University Cancer Hospital,shows that RFS in PEPI score ≤ 1 group is superior to the PEPI >
1 group after 16 weeks of neoadjuvant endocrinotherapy(p = 0.037), and RFS in effective
group (Miller&Payne G1G2G3) is better than that in ineffective group (p=0.001) in terms of
pathological evaluation.

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

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

- Evidence of primary invasive breast cancer is confirmed by histopathological

- Clinical stage is T2-3N0M0

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

RFS events includes local recurrence, regional recurrence, and distant metastasis resulted from breast cancer

Outcome Time Frame:

after a follow up of 5 years

Safety Issue:


Principal Investigator

Tao Ouyang, Doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Peking University Cancer Hospital Breast Center


China: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

December 2019

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms