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NCT Number: NCT06722599

Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among Low Risk HER2 Positive Patients

Neoadjuvant therapy in the treatment of breast cancer is not only a means of breast conserving surgery, but also a sensitive scheme for patients, in order to reduce the treatment grade, low toxicity and high efficiency. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Paclitaxel plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxus (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. In the HER2 positive neoadjuvant therapy population, relatively early and low-risk patients may obtain good curative effect in the treatment of single drug taxane chemotherapy combined with double target therapy.

The project plans to adopt an ambispective cohort study, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and retrospectively include the HER2 positive breast cancer patients with clinical stage T1c, lymph node negative and receiving Taxanes combined with double target neoadjuvant therapy admitted to the center from January 1, 2019 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. Objective to evaluate the efficacy and safety of Taxanes combined with double target neoadjuvant therapy.

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Key information

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

  • Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital;
  • The clinical stages were T1c, N0, M0;
  • Received treatment in our hospital and had hospitalization records;
  • Has signed and agreed to participate in the PKUPH breast disease cohort study;
  • It is up to the clinician to decide whether to add anthracycline chemotherapy in the adjuvant treatment stage.

Exclusion criteria

  • Lack of clinical and pathological data (such as imaging data and pathological data);
  • Patients with metastatic breast cancer or bilateral breast cancer;
  • At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy;
  • Receiving other regimens besides the established neoadjuvant regimens

Treatment and study plan

Primary outcomes

  1. pathology complete response

    Time frame: 4 months

    Postoperative pathology confirmed that the primary breast lesions and axillary lymph nodes had no residual invasive tumor cells (ypT0/is and ypN0)

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. 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.

  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

    the 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

Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among T1c HER2 Positive Patients

Acronym: LRNacHER2

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
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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