Status:
UNKNOWN
12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)
Lead Sponsor:
Ruijin Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
Detailed Description
Many clinical trials has showed the superiority of combining trastuzumab to chemotherapy in the treatment of HER2 positive early breast cancer with tumor size ≥1cm or node metastasis.But in pT1n0m0 br...
Eligibility Criteria
Inclusion
- Women aged ≥18 years
- Have finished radical operation
- Pathologically confirmed dignosis of infiltrating primary breast cancer
- According to AJCC ,pT≤1cm, pN0,no evidence for metastasis
- Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be Her2 positive tumor (3+ by IHC or FISH+ )
- Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1,expected survival time \> 12 months
- Adequate bone marrow function,adequate liver and renal function,and adequate coagulation function.
- Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
- Written informed consent according to the local ethics committee requirements.
Exclusion
- pT\>1cm or node positive
- Metastatic breast cancer
- Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
- With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
- Patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including severe infection, coagulation disorder,active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
- Has symptomatic peripheral neuropathy \> grade 2 according to NCI
- Known severe allergy to any drugs in this study
- Has cadiac Dysfunction or lung dysfunction defined as follows:
- grade ≥3 CHF according to NCI CTCAE v 4.0 or NYHA≥II
- angina which requires drug control ,cardiac infraction,and any other vascular disease with apparent clinical symptoms
- uncontrolled high-risk arryhthmia
- unconrolled hypertension
- Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
- Patient is pregnant or breast feeding
- \-
Key Trial Info
Start Date :
December 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03367676
Start Date
December 30 2017
End Date
June 1 2021
Last Update
March 10 2020
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025