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NCT Number: NCT06700369

De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients

Neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (HER2) positive and triple negative breast cancer, which meets the requirements of tumor ≥ 2cm and/or lymph node positive, and the guidelines recommend neoadjuvant therapy as the first choice. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Taxane plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxane (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. Considering the defects such as large side effects of combined chemotherapy, whether single drug chemotherapy can be used as the first choice for some people under the support of targeted drugs remains to be studied.

This project plans to a 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 patients with clinical stage T2 and above and/or lymph node positive breast cancer who received neoadjuvant therapy (TCbHP or THP) from January 1, 2015 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. The effectiveness and safety of TCbHP and THP as a neoadjuvant therapy were compared.

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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) Patients with HER2 positive breast cancer diagnosed by biopsy in Peking University People's Hospital;
  • 2) The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis);
  • 3) Received treatment in our hospital and had hospitalization records;
  • 4) 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) Patients with metastatic breast cancer or bilateral breast cancer;
  • 3) At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy;
  • 4) Receiving other regimens besides the established neoadjuvant regimens

Treatment and study plan

Primary outcomes

  1. pathology complete response

    Time frame: 6 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

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Shu Wang

Other

Registry information

Official study title

De-escalation of Neoadjuvant Chemotherapy Regimens (Taxanes Plus Carboplatin Versus Taxanes Only) With Target Therapy Among HER2 Positive Patients

Acronym: NacHER2

Important dates

Study start
2015
Primary completion
2028
Study completion
2031
First posted
Nov 22, 2024
Registry last updated
Nov 25, 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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