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Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer

Cohort Study of Chemotherapy Combined With Targeted Adjuvant Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06722612
Acronym
TaxCbHER2
Enrollment
2916
Registered
2024-12-09
Start date
2019-01-01
Completion date
2031-12-31
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive Breast Cancer

Keywords

Taxane, target therapy, carboplatin

Brief summary

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.

Interventions

None listed

Sponsors

Shu Wang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 1\) Treated in Peking University People's Hospital and underwent radical resection with hospitalization records; * 2\) Postoperative pathology confirmed invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative); * 3\) Has signed and agreed to participate in the PKUPH breast disease cohort study.

Exclusion criteria

* 1\) Lack of clinical and pathological data (such as imaging data and pathological data); * 2\) Preoperative neoadjuvant therapy; * 3\) Patients with metastatic breast cancer or bilateral breast cancer; * 4\) Failure to perform radical surgery.

Design outcomes

Primary

MeasureTime frameDescription
disease free survival5 yearsThe time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.

Secondary

MeasureTime frameDescription
invasive disease free survival5 yearsThe time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.
distant disease free survival5 yearsTime from study enrollment to distant recurrence and metastasis
breast cancer specific survival5 yearsTime from study enrollment to death due to breast cancer
overall survival5 yearsTime from study enrollment to death from any cause

Countries

China

Contacts

Primary Contactyuan peng, doctor
13671287670@163.com86+13671287670

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026