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

NCT ID: NCT04249440

Last Updated: 2020-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1067 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2020-03-30

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.

Conditions

Breast Cancer; HER2; Preoperative Systemic Treatment

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

PST

patient accepts preoperative systemic treatment as upfront strategy

Preoperative systemic treatment

Intervention Type: PROCEDURE

neoadjuvant chemotherapy combined with trastuzumab as preoperative systemic treatment

upfront surgery

patient accepts upfront surgery and run postoperative systemic treatment

No interventions assigned to this group

Interventions

Preoperative systemic treatment

neoadjuvant chemotherapy combined with trastuzumab as preoperative systemic treatment

Intervention Type: PROCEDURE

Other Intervention Names

neoadjuvant treatment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

YU Xingfei

Department of Breast Tumor Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingfei Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

References

Yu X, Wang C, Zheng Y, Miao B, Hu J, Shao X, Sheng L, Lin J, Ding Y, Xuan H, Ding Y, Gong L, Feng W, Qin C, Chen D, Yu Y, Yang H. Preoperative Systemic Therapy Versus Upfront Surgery in HER2-Positive Breast Cancer in the Real World. Front Oncol. 2021 Jul 28;11:704842. doi: 10.3389/fonc.2021.704842. eCollection 2021.

Reference Type: DERIVED

PMID: 34395277 (View on PubMed)

Other Identifiers

HER2-RWSNeo

Identifier Type: -

Identifier Source: org_study_id