12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)
- Registration Number
- NCT03367676
- Lead Sponsor
- Ruijin Hospital
- 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 breast cancer patients, patients with HER2 positive tumor show worse prognosis than those with HER2 negative tumor.A short duration of trastuzumab administration contaminately with chemotherapy may have similar efficacy and lowerer toxiticy compared with standard one year therapy.Our study 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 112
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Arm Docetaxel 12 weeks adjuvant docetaxel plus trastuzumab Experimental Arm Trastuzumab 12 weeks adjuvant docetaxel plus trastuzumab
- Primary Outcome Measures
Name Time Method Disease-free Survival 3-year estimates Estimated percentage of patients alive and disease-free at 3 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
- Secondary Outcome Measures
Name Time Method Breast Cancer Specific Survival 3-year estimates Estimated percentage of patients alive and disease-free at 3 years from randomization, where breast cancer specific survival is defined as the time from randomization to death from breast cancer relapse; or censored at date last known alive.
Change of LVEF after treatment up to 4 months The change of LVEF after 12 weeks treatment compared to the baseline LVEF
Overall Survival 3-year estimats Estimated percentage of patients alive and disease-free at 3 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Treatment-related adverse events up to 4 months Incidence and severity of adverse events as assessed by NCI CTCAE V4.0
Trial Locations
- Locations (1)
Ruijin Hospital
🇨🇳Shanghai, Shanghai, China