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NCT Number: NCT06711068

Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy

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 trastuzumab and pertuzumab 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. 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.

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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

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 T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative);
  • 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. disease free survival

    Time frame: 3 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.

Secondary outcomes

  1. invasive disease free survival

    Time frame: 3 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.

  2. distant disease free survival

    Time frame: 3 years

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

  3. breast cancer specific survival

    Time frame: 3 years

    Time from enrollment to death due to breast cancer

  4. overall survival

    Time frame: 3 years

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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Shu Wang

Other

Registry information

Official study title

Cohort Study of Adjuvant Chemotherapy Combined With Targeted Therapy for Intermediate Risk HER2 Positive and Lymph Node Negative Early Breast Cancer

Acronym: TaxDHER2

Important dates

Study start
2019
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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