NCT06711068Recruiting
Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy
Cohort Study of Adjuvant Chemotherapy Combined With Targeted Therapy for Intermediate Risk HER2 Positive and Lymph Node Negative Early Breast Cancer
Source: ClinicalTrials.gov · Last updated 2 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 trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. 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
- 8077 (estimated)
- First submitted
- 26 Nov 2024
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Shu Wang
- Diseases
- Childhood cancers
- NCT number
- NCT06711068
What you commit to
- Study type: Observational
- Planned participants: 8077
- 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;
- 4\) Failed to undergo curative surgery.
Other illness
- 3\) Patients with metastatic breast cancer or bilateral breast cancer;
Other
- 1\) Lack of clinical pathological data (such as imaging data, pathological data);
Who the study is looking for
- 1\) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records;
- 2\) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative);
- 3)Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page 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.