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

September 12, 2022 updated by: Caigang Liu, Shengjing Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Cai-Gang Liu, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stage II-III HR+/HER2+ Early Breast Cancer
Drug: Standard Therapy
Standard Therapy, including TCbHP, THP, EC-THP, AC-THP
Other Names:
  • TCbHP, THP, EC-THP, AC-THP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total pathological complete response (tpCR)
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment
Time Frame: through study completion, an average of 1 year
The proportion of patients who respond to the treatment at any study time point
through study completion, an average of 1 year
Residual cancer burden (RCB)
Time Frame: through study completion, an average of 1 year
RCB score is obtained according to pathological evaluation after completion of neoadjuvant treatment and surgery
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: Within 5 years after surgery
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
Overall survival (OS)
Time Frame: Within 5 years after surgery
It refers to the length of time from the start of treatment to the death of the patient.
Within 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Investigators

  • Study Chair: Caigang Liu, PHD, Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

February 27, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-HER2-RWS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe