NCT06722599Recruiting
Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among Low Risk HER2 Positive Patients
Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among T1c HER2 Positive Patients
Source: ClinicalTrials.gov · Last updated 9 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 171 (estimated)
- First submitted
- 4 Dec 2024
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Shu Wang
- Diseases
- Childhood cancers
- NCT number
- NCT06722599
What you commit to
- Study type: Observational
- Planned participants: 171
- From 1 Jan 2019 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with metastatic breast cancer or bilateral breast cancer;
Other
- Lack of clinical and pathological data (such as imaging data and pathological data);
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.