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NCT Number: NCT05263570

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location status: Recruiting

Location contact

Cai-Gang Liu, PHD

CONTACT

[email protected]

+86 18940254967

Cai-Gang Liu, PHD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard therapy

Drug

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

Other names: TCbHP, THP, EC-THP, AC-THP

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nan Niu, MD

CONTACT

[email protected]

+8618940256668

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Mar 2, 2022
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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