Skip to content

Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer

A Cohort Study of Adjuvant Therapy With Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06711055
Acronym
TaxHER
Enrollment
285
Registered
2024-12-02
Start date
2015-01-01
Completion date
2031-12-31
Last updated
2024-12-02

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

Brief summary

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk of recurrence and metastasis. 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 trastuzumab and paltuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. To explore the efficacy and safety of adjuvant therapy of taxane chemotherapy combined with trastuzumab targeting therapy for low-risk HER2 positive and lymph node negative early breast cancer.

Interventions

None listed

Sponsors

Shu Wang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* 1\) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records; * 2\) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1a-b (T ≤ 1cm), N0, HER2 positive, with high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T1c (1cm \< T ≤ 2cm), N0, and there are no high-risk factors (G1/G2, hormone receptor positive); * 3)Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.

Exclusion criteria

* 1\) Lack of clinical pathological data (such as imaging data, pathological data); * 2\) Preoperative neoadjuvant therapy; * 3\) Patients with metastatic breast cancer or bilateral breast cancer; * 4\) Failed to undergo curative surgery.

Design outcomes

Primary

MeasureTime frameDescription
invasive disease free survival5 yearsThe time from 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.

Secondary

MeasureTime frameDescription
disease free survival5 yearsThe time from 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.
distant disease free survival5 yearsThe time from enrollment in the study to the occurrence of distant recurrence and metastasis.
breast cancer specific survival5 yearsTime from enrollment to death due to breast cancer. Time from enrollment to death due to breast cancer.
overall survival5 yearsThe time from enrollment in the study to death caused by any reason

Countries

China

Contacts

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

Outcome results

None listed

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