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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed the informed consent.
Female aged between 18 and 70 years.
Pathologically diagnosed operable invasive breast cancer meeting the following criterias:
WHO Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Newly diagnosed breast cancer.
The important organ functions meet the following criterias:
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:
Pregnant or nursing females.
Primary purpose
Allocation
Interventional model
Masking
185 participants in 2 patient groups
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Central trial contact
Erwei Song, M.D., Ph.D.; Shicheng Su, M.D., Ph.D.
Data sourced from clinicaltrials.gov
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