NCT06693037 Adjuvant Therapy Choice for Non-pCR HER2 Positive Early Breast Cancer After Neoadjuvant Therapy
| NCT ID | NCT06693037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shu Wang |
| Condition | HER2-positive Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,092 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,092 participants in total. It began in 2019-01-01 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chemotherapy combined with trastuzumab and patuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. The survival rate of patients with pathological complete response (PCR) after neoadjuvant therapy was significantly better than that of patients with tumor residue, that is, non-PCR. Therefore, studies have confirmed that adjuvant therapy for patients with non-PCR after neoadjuvant chemotherapy can further improve the prognosis and survival of this population. However, the results of previous studies are based on trastuzumab target therapy in neoadjuvant therapy. Therefore, there are different recommendations for the current guidelines of adjuvant therapy after trastuzumab combined pertuzumab target neoadjuvant therapy. Patients with HER2 positive breast cancer who received trastuzumab and patuzumab based neoadjuvant therapy had invasive residual cancer in postoperative pathology. The effect of postoperative adjuvant therapy with trastuzumab and patuzumab or replacement of T-DM1 on survival.
Eligibility Criteria
Inclusion Criteria: * 1\) Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital; * 2\) The clinical stages before treatment were T1-T4, N0-N3, M0; * 3\) Received treatment and operation in our hospital, and had hospitalization records; * 4\) Receive at least 4 cycles of trastuzumab and pertuzumab target therapy combined chemotherapy as neoadjuvant therapy * 5\) Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or metastatic tumor lesions in axillary lymph nodes; * 6\) Has signed and agreed to participate in the PKUPH breast disease cohort study. Exclusion Criteria: * 1\) Lack of clinical and pathological data (such as imaging data and pathological data); * 2\) Patients with metastatic breast cancer or bilateral breast cancer; * 3\) Failure to perform radical surgery; * 4\) Receiving other regimens besides the established neoadjuvant regimens.
Contact & Investigator
shu wang, doctor
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06693037 clinical trial?
This trial is open to participants of all sexes, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06693037 currently recruiting?
Yes, NCT06693037 is actively recruiting participants. Contact the research team at 13671287670@163.com for enrollment information.
Where is the NCT06693037 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06693037 clinical trial?
NCT06693037 is sponsored by Shu Wang. The principal investigator is shu wang, doctor at Peking University People's Hospital. The trial plans to enroll 2,092 participants.
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