Breast Cancer Clinical Trial
Official title:
Preoperative Systemic Therapy Versus Upfront Surgery in HER2 Positive Early Breast Cancer: a Prospective Nested Case-control Study in Real World
NCT number | NCT04249440 |
Other study ID # | HER2-RWSNeo |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2012 |
Est. completion date | March 30, 2020 |
Verified date | September 2020 |
Source | Zhejiang Cancer Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Preoperative systemic treatment can make patients getting more opportunity for breast-conserving surgery, down-staging and new drugs developing. It is particularly common in human epidermal growth factor receptor 2 (HER2)-over expressing subtype for as high as 40%~60% pCR rate of such a population. Even though, in NSABP B18/27 trials, it had been proved that PST could not improve either disease-free survival (DFS) or overall survival (OS) comparing with postoperatively systemic treatment in total population. We designed a real-world study to investigate the prognosis of anti-HER2 treatment combined with chemotherapy preoperatively versus postoperatively in HER2-positive early breast cancer
Status | Completed |
Enrollment | 1067 |
Est. completion date | March 30, 2020 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. HER2 positive 2. early invasive breast cancer (cT1-3N0-1M0) 3. using one-year trastuzumab as anti-HER2 treatment Exclusion Criteria: 1. Exclude metastasis and recurrent breast cancer 2. using trastuzumab less than a year |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Cancer Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival | as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer | 5 years | |
Secondary | Overall survival | the time from study entry to death from any cause | 5 years |
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