Observing the effectiveness of standard neoadjuvant therapy for early breast cancer
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.
Shengjing Hospital · NCT05263570
This study looks at how well standard treatments for early breast cancer work in real-life settings for patients with specific types of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shengjing Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT05263570 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of standard neoadjuvant therapies in patients with stage II-III HR+/HER2+ early breast cancer. It is a retrospective, multicenter analysis that collects data on clinical characteristics and outcomes of patients treated with therapies such as TCbHP, THP, EC-THP, and AC-THP. The study focuses on real-world settings to provide insights into the treatment's efficiency and patient responses.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with stage II-III HR+/HER2+ breast cancer who have not received prior anti-tumor treatments.
Not a fit: Patients with stage IV breast cancer or those who have received previous anti-tumor treatments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of treatment effectiveness for early breast cancer, leading to improved patient outcomes.
How similar studies have performed: Other studies have shown success with similar approaches in evaluating neoadjuvant therapies for breast cancer, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shenyang, Liaoning
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
Study contacts
- Study coordinator: Nan Niu, MD
- Email: niunannancy@163.com
- Phone: +8618940256668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, standard Therapy （TCbHP/THP/EC-THP/AC-THP）