Status:
UNKNOWN
Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
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 prolif...
Eligibility Criteria
Inclusion
- Signed the informed consent.
- Female aged between 18 and 70 years.
- Pathologically diagnosed operable invasive breast cancer meeting the following criterias:
- 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 \>=1.5×10\^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
- 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.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT04023292
Start Date
July 1 2019
End Date
July 1 2025
Last Update
July 17 2019
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120