NCT06722612Recruiting
Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer
Cohort Study of Chemotherapy Combined With Targeted Adjuvant Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer
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)
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2916 (estimated)
- First submitted
- 4 Dec 2024
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Shu Wang
- Diseases
- Childhood cancers
- NCT number
- NCT06722612
What you commit to
- Study type: Observational
- Planned participants: 2916
- From 1 Jan 2019 to the primary completion date, 31 Dec 2031
- 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
- 2\) Preoperative neoadjuvant therapy;
Other illness
- 3\) Patients with metastatic breast cancer or bilateral breast cancer;
- 4\) Failure to perform radical surgery.
Other
- 1\) Lack of clinical and pathological data (such as imaging data and pathological data);
Who the study is looking for
- 1\) Treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
- 2\) Postoperative pathology confirmed invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative);
- 3\) Has signed and agreed to participate in the PKUPH breast disease cohort study.
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.