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

  • End date
    Jul 22, 2025
  • participants needed
  • sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Updated on 12 February 2022
breast cancer
growth factor
endocrine therapy
hormone therapy
tumor cells
epidermal growth factor receptor
progesterone receptor
epidermal growth factor
estrogen receptor
invasive breast cancer


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.

Condition Breast Neoplasms
Treatment Endocrine Therapy
Clinical Study IdentifierNCT04023292
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Last Modified on12 February 2022


Yes No Not Sure

Inclusion Criteria

Signed the informed consent
Female aged between 18 and 70 years
Pathologically diagnosed operable invasive breast cancer meeting the following
Hormone receptor (HR)-positive: pathologically diagnosed estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive
Human epidermal growth factor receptor 2 (HER2)-negative: FISH or immunohistochemistry (IHC)
WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Newly diagnosed breast cancer
The important organ functions meet the following criterias
WBC >=3.0 x 10^9/L; Neutrophilic granulocytes >=1.510^9/L; Platelet >=100 x 10^9/L; Hb >=9 g/dL
Total bilirubin no more than 1.5 times the normal upper limit (ULN); AST and ALT no more than 1.5 times ULN; AKP no more than 2.5 times ULN
Serum creatinine no more than 1.5 times ULN or Clearance rate of creatinine >= 60ml/min
Thyroid stimulating hormone (TSH) <= ULN (T3, T4 levels need to be detected simultaneously if abnormalities, the patient can be included if T3, T4 levels is normal)
LVEF basement >= 50%
Able to swallow tablets
Pregnancy test (serum or urine HCG test within 72h before enrollment) must be negative in non-surgical sterilization or women of childbearing age, must be not for the nursing and be willing to take non-pharmacological contraception during treatment (such as intrauterine device, condom, etc)

Exclusion Criteria

Evidence of distant metastasis
Bilateral or multiple unilateral breast tumors with different histological characteristics (such as ER/PR/HER2 status, tumor grade or type, etc)
Any invasive malignancy diagnosed within previous 5 years (other than successfully treated cervical carcinoma in situ, skin basal cell carcinoma or cutaneous squamous cell carcinoma)
Prior radiotherapy, chemotherapy, endocrine therapy, targeted therapy etc
Concurrent use of HRT or any other estrogen-containing medication (including vaginal estrogens) within 4 weeks
Prior use of estrogen implants
Prior use of high-dose systemic corticosteroids (except as antiemetic treatment), immunotherapy, or biological response modifiers (e.g., interferon, etc)
Use of an unlicensed or other investigational drug within 4 weeks
Any severe comorbidities, inability to give informed consent or unavailability for follow-up, including but not limited to any of the following
Heart failure above NYHA class 2 level; high-risk uncontrollable arrhythmia; unstable angina pectoris; myocardial infarction within 1 year; valvular heart disease with clinically significance or requiring intervention
Chronic obstructive pulmonary disease requires treatment
Chronic liver disease (cirrhosis, chronic active hepatitis, etc)
Cerebrovascular accident occurred within 6 months
Severe epilepsy or central nervous system diseases
Hypertension which cannot be well controlled by antihypertensive drugs
Abnormal coagulation, bleeding tendency, or receiving thrombolysis or anticoagulant therapy
Chronic renal insufficiency
Active infection
Psychiatric disability, etc
Pregnant or nursing females
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