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

NCT06700369 | Recruiting

• 1 other identifier: PKUPH2024Z161
• Study Type: observational
• Target: 519
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2-positive Breast Cancer

Keywords

neoadjuvant chemotherapy; De-escalation

Outcome Measures

Primary Outcomes (1)

• pathology complete response

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

  6 months

Secondary Outcomes (4)

• Invasive disease free survival

  5 years

• Disease free survival

  5 years

• Breast cancer specific survival

  5 years

• Overall survival

  5 years

Study Arms (2)

Taxanes combined with carboplatin

Taxane (paclitaxel, liposome paclitaxel, docetaxel, albumin paclitaxel), carboplatin combined with trastuzumab and pertuzumab, 6 cycles in total

Taxanes

Taxane (paclitaxel, liposome paclitaxel, docetaxel, albumin paclitaxel) with trastuzumab and pertuzumab, 6 cycles in total

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HER2 positive breast cancer patients who received neoadjuvant chemotherapy based on taxanes with trastuzumab, pertuzumab target therapy

You may qualify if:

• \) Patients with HER2 positive breast cancer diagnosed by biopsy in Peking University People's Hospital;
• \) The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis);
• \) Received treatment in our hospital and had hospitalization records;
• \) Has signed and agreed to participate in the PKUPH breast disease cohort study.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Shu Wang: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Study Officials

• shu wang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yuan peng, doctor

CONTACT

86+13671287670; 13671287670@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of breast center

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: January 1, 2015
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CN (1)