Status:
UNKNOWN
Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer
Lead Sponsor:
Zhiyong Yu
Conditions:
Breast Cancer
Chemotherapy
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Breast cancer is the most common female malignancy in the world, and the leading cause of cancer-associated mortalities among women. Hormone receptors (HR) including ER and PR are the main prognostic ...
Detailed Description
The trial is designed to investigative the risk and clinical benefit of chemotherapy and intensive endocrine therapy for Luminal B1 early-staged breast cancer. In this trial the investigators will ran...
Eligibility Criteria
Inclusion
- All patients were required to give written informed consent.
- Patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
- Have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy
- Have normal cardiac functions by echocardiography
- ECOG scores are ≤ 0-1.
- Patients are disposed to practice contraception during the whole trial.
- The results of patients' blood tests are as follows:
- Hb ≥ 90 g/L WBC ≥ 3.0×109/L Plt ≥ 100×109/L Neutrophils ≥ 1.5×109/L ALT and AST ≤ 2.5 times of normal upper limit. TBIL ≤ 1.5 times of normal upper limit. Creatinine ≤ 1.5 times of normal upper limit.
- ER+ Her2- early-stage breast cancer
Exclusion
- Have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
- Active infections
- Severe non-cancerous diseases.
- The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
- Inflammatory breast cancer.
- Pregnant or lactational, or patients refuse to practice contraception during the whole trial.- Page 5 of 5 -
- The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
- Have allergic history of the chemotherapeutic agents.
- Bilateral breast cancers
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03373708
Start Date
December 20 2017
End Date
December 20 2019
Last Update
December 18 2017
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