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
endocrinotherapy.
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
endocrinotherapy.
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
endocrinotherapy.
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
endocrinotherapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
RFS
RFS events includes local recurrence, regional recurrence, and distant metastasis resulted from breast cancer
after a follow up of 5 years
No
Tao Ouyang, Doctor
Study Chair
Peking University Cancer Hospital Breast Center
China: Food and Drug Administration
BCP08
NCT01613560
June 2012
December 2019
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