The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.

NCT05263570 | Recruiting

• 1 other identifier: HR-HER2-RWS-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.

Conditions

Breast Cancer

Keywords

standard Therapy （TCbHP/THP/EC-THP/AC-THP）

Outcome Measures

Primary Outcomes (1)

• Total pathological complete response (tpCR)

  tpCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment

  through study completion, an average of 1 year

• Residual cancer burden (RCB)

  through study completion, an average of 1 year

Other Outcomes (2)

• Overall survival (OS)

  Within 5 years after surgery

• Disease-free survival (DFS)

  Within 5 years after surgery

Study Arms (1)

Stage II-III HR+/HER2+ Early Breast Cancer

Stage II-III HR+/HER2+ Early Breast Cancer

Drug: Standard Therapy

Interventions

Standard Therapy DRUG

Standard Therapy, including TCbHP, THP, EC-THP, AC-THP

Also known as: TCbHP, THP, EC-THP, AC-THP

Stage II-III HR+/HER2+ Early Breast Cancer

Eligibility Criteria

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

Study Population

Patients diagnosed with stage II-III HR+/HER2+ early breast cancer.

You may qualify if:

• Age ≥18 years or older
• HR+/HER2- breast cancer diagnosis based on local standards
• Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time
• Standard Therapy, determined at the discretion of the investigator, including （TCbHP/THP/EC-THP/AC-THP）
• Complete medical history was available
• Karnofsky Performance Status (KPS) Scale score ≥ 70

You may not qualify if:

• Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
• Pregnant or breast-feeding women
• Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer
• Those who have stage IV breast cancer

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Caigang Liu, PHD

  Shengjing Hospital

  STUDY CHAIR

Central Study Contacts

Nan Niu, MD

CONTACT

+8618940256668; niunannancy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: March 2, 2022
• Study Start: August 1, 2022
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

CN (1)