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NCT Number: NCT06711055

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

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.

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Key information

Conditions

HER2-positive Breast Cancer

Sex eligibility

Female

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

yuan peng

CONTACT

86+13671287670

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. invasive disease free survival

    Time frame: 5 years

    The 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 outcomes

  1. disease free survival

    Time frame: 5 years

    The 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.

  2. distant disease free survival

    Time frame: 5 years

    The time from enrollment in the study to the occurrence of distant recurrence and metastasis.

  3. breast cancer specific survival

    Time frame: 5 years

    Time from enrollment to death due to breast cancer. Time from enrollment to death due to breast cancer.

  4. overall survival

    Time frame: 5 years

    The time from enrollment in the study to death caused by any reason

Study contacts

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

yuan peng, doctor

CONTACT

[email protected]

86+13671287670

Sponsors and collaborators

Lead sponsor

Shu Wang

Other

Registry information

Official study title

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

Acronym: TaxHER

Important dates

Study start
2015
Primary completion
2031
Study completion
2031
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

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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