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Trastuzumab

patient accepts preoperative systemic treatment as upfront strategy

patient accepts upfront surgery and run postoperative systemic treatment

neoadjuvant chemotherapy combined with trastuzumab as preoperative systemic treatment

Preoperative systemic treatment

Xingfei Yu, M.D.

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

Patients with a diagnosis of HER2 positive early invasive breast cancer (cT1-3N0-1M0), from January 2012 to December 2014 were identified and enrolled continuously. The conditions of HER2-positive expression of primary breast cancer were defined as follows: HER2 3+ by immunohistochemical (IHC) method or HER2 2+ by IHC with a further positive result by fluorescence in situ hybridization (FISH). According to the real upfront treatment, all eligible patients were classified as PST group and surgery group. All the patients accepted standard one-year trastuzumab as anti-HER2 treatment combined with chemotherapy. In the PST group, the effect was evaluated according to RECIST1.1 every two cycles, the patients with clinical complete response (cCR) or partial response (PR) would receive the whole course of chemotherapy, those with stable disease (SD) or progressive disease (PD) would receive surgery promptly. After surgery, all patients underwent irradiation and endocrine therapies if necessary. The pCR was defined as the absence of infiltrating residual invasive disease in the breast and axillary nodes. For those non-pCR patients after PST, intensive adjuvant chemotherapy was not routine treatment except patients with progressive disease.The primary endpoint was DFS defined as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer. Patients suffered disease progress becoming inoperable before surgery were counted as local treatment failures. The second endpoint was OS defined as the time from study entry to death from any cause. All the endpoints were compared between PST group and upfront surgery group, also further analysis according to pathological response status stratified in PST group.

Preoperative Systemic Therapy vs Upfront Surgery in HER2 Positive Early Breast Cancer

Preoperative Systemic Therapy Versus Upfront Surgery in HER2 Positive Early Breast Cancer: a Prospective Nested Case-control Study in Real World

There is no plan to make individual participant data available to others

as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer

the time from study entry to death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Systemic Therapy vs Upfront Surgery in HER2 Positive Early Breast Cancer	NCT04249440	Breast Cancer HER2 Preoperative Sy...	Preoperative sy...	18 Years - 80 Years	Zhejiang Cancer Hospital
Preoperative Systemic Therapy vs Upfront Surgery in HER2 Positive Early Breast Cancer	NCT04249440	Breast Cancer HER2 Preoperative Sy...	Preoperative sy...	18 Years - 80 Years	Zhejiang Cancer Hospital
Preoperative Systemic Therapy vs Upfront Surgery in HER2 Positive Early Breast Cancer	NCT04249440	Breast Cancer HER2 Preoperative Sy...	Preoperative sy...	18 Years - 80 Years	Zhejiang Cancer Hospital

Spots Global Cancer Trial Database for preoperative systemic treatment