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

NCT04249440 | Completed DMC

• 1 other identifier: HER2-RWSNeo
• Study Type: observational
• Target: 1,067
• Locations: 0 countries
• Sites: N/A

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

Conditions

Breast Cancer; HER2; Preoperative Systemic Treatment

Keywords

breast cancer; HER2; preoperative systemic treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival

  5 years

Study Arms (2)

PST

patient accepts preoperative systemic treatment as upfront strategy

Procedure: Preoperative systemic treatment

upfront surgery

patient accepts upfront surgery and run postoperative systemic treatment

Interventions

Preoperative systemic treatment PROCEDURE

neoadjuvant chemotherapy combined with trastuzumab as preoperative systemic treatment

Also known as: neoadjuvant treatment

PST

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2 positive early invasive breast cancer, using trastuzumab for one year both in neoadjuvant or adjuvant setting.

You may qualify if:

• HER2 positive
• early invasive breast cancer (cT1-3N0-1M0)
• using one-year trastuzumab as anti-HER2 treatment

You may not qualify if:

• Exclude metastasis and recurrent breast cancer
• using trastuzumab less than a year

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Related Publications (1)

• 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.

  PMID: 34395277 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Xingfei Yu, M.D.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Breast Tumor Surgery

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: January 1, 2012
• Primary Completion: December 30, 2019
• Study Completion: March 30, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share