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NCT Number: NCT06722612

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

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.

Recruiting

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Key information

Conditions

HER2-positive Breast Cancer

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

yuan peng, doctor

CONTACT

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. disease free survival

    Time frame: 5 years

    The 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 outcomes

  1. invasive disease free survival

    Time frame: 5 years

    The 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.

  2. distant disease free survival

    Time frame: 5 years

    Time from study enrollment to distant recurrence and metastasis

  3. breast cancer specific survival

    Time frame: 5 years

    Time from study enrollment to death due to breast cancer

  4. overall survival

    Time frame: 5 years

    Time from study enrollment to death from any cause

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

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

Acronym: TaxCbHER2

Important dates

Study start
2019
Primary completion
2031
Study completion
2031
First posted
Dec 9, 2024
Registry last updated
Dec 9, 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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