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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.
Docetaxel 100mg/m2,d1,iv,q3w\*4
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Disease-free Survival
Disease-free survival is defined as the time from the date of surgery to the first appearance of one of the following: breast cancer in situ or 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.
Time frame: 3-year estimates
Breast Cancer Specific Survival
Defined as the time from the date of surgery to death from breast cancer relapse; or censored at date last known alive.
Time frame: 3-year estimates
Overall Survival
Defined as the time from the date of surgery to death from any cause; or censored at date last known alive.
Time frame: 3-year estimats
Treatment-related adverse events
Incidence and severity of adverse events as assessed by NCI CTCAE V4.0
Time frame: up to 4 months
Change of LVEF after treatment
The change of LVEF after 12 weeks treatment compared to the baseline LVEF
Time frame: up to 4 months
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