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

NCT06722599 | Recruiting

• 1 other identifier: PKUPH2024Z162
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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)

  4 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 (1)

four cycles of Taxanes combined with target therapy

Four cycle neoadjuvant therapy with taxanes combined with trastuzumab and pertuzumab

Eligibility Criteria

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

Study Population

T1cN0M0 HER2 positive breast cancer patients who received neoadjuvant chemotherapy based on taxanes combined with target therapy

You may qualify if:

• 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.

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

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: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CN (1)