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

Completed

• Conditions: Breast Cancer; HER2; Preoperative Systemic Treatment
• Interventions: Procedure: Preoperative systemic treatment

• Registration Number: NCT04249440
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2019-12-30
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Study Completion: 2020-03-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1067

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PST	Preoperative systemic treatment	patient accepts preoperative systemic treatment as upfront strategy

Primary Outcome Measures

Name	Time	Method
Disease free survival	5 years	as the time from enrollment to local, regional, or distant recurrences; the occurrence of contralateral breast cancer; or death without evidence of breast cancer

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	the time from study entry to death from any cause