Breast Cancer
Conditions
Keywords
standard Therapy （TCbHP/THP/EC-THP/AC-THP）
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.
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.
Interventions
DRUGStandard Therapy
Standard Therapy, including TCbHP, THP, EC-THP, AC-THP
Sponsors
Shengjing Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total pathological complete response (tpCR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment | through study completion, an average of 1 year | The proportion of patients who respond to the treatment at any study time point |
| Residual cancer burden (RCB) | through study completion, an average of 1 year | RCB score is obtained according to pathological evaluation after completion of neoadjuvant treatment and surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Within 5 years after surgery | It refers to the length of time from the start of treatment to the death of the patient. |
| Disease-free survival (DFS) | 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. |
Countries
China
Contacts
Primary ContactNan Niu, MD
Outcome results
None listed