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Patients receive endocrine therapy before surgery for 2 weeks. Choice of endocrine therapy is according to guidelines and centre policy.

Patients receive endocrine therapy before surgery for 4 weeks. Choice of endocrine therapy is according to guidelines and centre policy.

Use before surgery for 2 weeks. Choice of endocrine therapy is according to guidelines and centre policy.

Endocrine therapy

Use before surgery for 4 weeks. Choice of endocrine therapy is according to guidelines and centre policy.

Shicheng Su, M.D., Ph.D.

Erwei Song, M.D., Ph.D.

Shicheng Su, M.D.,Ph.D.

Erwei Song, M.D.,Ph.D.

RATIONALE: Estrogen can promote proliferation of tumor cells in hormone receptors (HR)-positive breast cancer. The standard therapy of Luminal subtypes is endocrine therapy, which can influence proliferation of tumor cells by blocking the use of estrogen by cancer cells or lowering the amount of estrogen the body makes. Thus, markers of proliferation are candidate markers of efficacy after short-term (e.g., 2 weeks or 4 weeks) preoperative hormone therapy. Ki-67 is most commonly used among these markers. In contrast to the absolute value, the degree of Ki-67 changes which consider the baseline values would be better to reflect the sensitivity of therapy. It is not yet known whether the degree of Ki-67 changes after 2 weeks or 4 weeks presurgery endocrine therapy is different and which interval is more suitable to assess therapy sensitivity.

PURPOSE: This randomized phase II trial is studying to compare the degree of Ki-67 changes after 2 weeks or 4 weeks preoperative endocrine therapy and to determine a more appropriate interval to assess hormone therapy sensitivity in women who are undergoing surgery for HR-positive, Human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer

Ki-67 labelling index is calculated as the percentage of cells with Ki-67-positive nuclear immunostaining as measured by immunohistochemistry (IHC). Range 0-100. Percentage change from pre-treatment to post-treatment=\[(Ki-67post - Ki-67pre)/Ki-67pre\]x100%

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Director of Shuhua Breast Cancer Research Center of Sun Yat-sen Memorial Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer	NCT04023292	Breast Neoplasm...	Endocrine thera... Endocrine thera...	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer	NCT04023292	Breast Neoplasm...	Endocrine thera... Endocrine thera...	18 Years - 70 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for preoperative endocrine therapy