12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)

Study Overview
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Brief Summary
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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
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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.

Official Title
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12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Tumors ≤1cm, Node-negative, HER2-positive Breast cancER (SOBER):a Single-grouparm, Open-label, Prospective, Phase 2 Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Trastuzumab
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>12 weeks adjuvant docetaxel plus trastuzumab | Drug: Trastuzumab<br>* Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.<br>Drug: Docetaxel<br>* Docetaxel 100mg/m2，d1，iv，q3w*4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival | 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. | 3-year estimates | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast Cancer Specific Survival | 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. | 3-year estimates | 
| Overall Survival | 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. | 3-year estimats | 
| Treatment-related adverse events | Incidence and severity of adverse events as assessed by NCI CTCAE V4.0 | up to 4 months | 
| Change of LVEF after treatment | The change of LVEF after 12 weeks treatment compared to the baseline LVEF | up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trastuzumab, adjuvant therapy