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

Breast Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263570
• Other study ID #: HR-HER2-RWS-01
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2022
• Source: Shengjing Hospital
• Contact: Nan Niu, MD
• Phone: +8618940256668
• Email: niunannancy[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study collected patients used standard neoadjuvant therapy (TCbHP/THP/EC-THP/AC-THP) among stage II-III HR+/HER2+ early breast cancer, and to describe patient clinical characteristics and clinical outcomes of them in real world settings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Standard Therapy
Standard Therapy, including TCbHP, THP, EC-THP, AC-THP

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival (OS)	It refers to the length of time from the start of treatment to the death of the patient.	Within 5 years after surgery
Other	Disease-free survival (DFS)	It refers to the length of time from the start of medication after enrollment to the death of the patient because of the recurrence, distant metastasis of the disease, invasive contralateral breast cancer, or any other cause.	Within 5 years after surgery
Primary	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	Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment	The proportion of patients who respond to the treatment at any study time point	through study completion, an average of 1 year
Secondary	Residual cancer burden (RCB)	RCB score is obtained according to pathological evaluation after completion of neoadjuvant treatment and surgery	through study completion, an average of 1 year