Neoadjuvant therapy for low-risk HER2-positive breast cancer patients
Official title: Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among T1c HER2 Positive Patients
Run by Peking University People's Hospital · NCT06722599 · Data updated 2026-11-12
This study is testing a new treatment plan for people with low-risk HER2-positive breast cancer to see if combining certain chemotherapy drugs with targeted therapy can work just as well with less intense treatment.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 171 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, trastuzumab, pertuzumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | December 9, 2024 |
| Trial ID | NCT06722599 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with T1c, N0, M0 HER2-positive breast cancer at Peking University People's Hospital.
✕Probably not a fit
Patients with metastatic breast cancer, bilateral breast cancer, or those receiving other anti-tumor therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of a neoadjuvant therapy regimen combining single-agent taxane chemotherapy with trastuzumab and pertuzumab in patients with low-risk HER2-positive breast cancer. It aims to assess the potential for reduced treatment intensity while maintaining efficacy and minimizing toxicity. The approach is based on a large cohort database from Peking University People's Hospital, focusing on patients diagnosed with early-stage HER2-positive breast cancer. The study will utilize an ambispective cohort design to gather and analyze data from these patients.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and less toxic treatment options for patients with HER2-positive breast cancer.
How similar studies have gone: While the combination of taxane with trastuzumab and pertuzumab is standard, the specific focus on low-risk patients with single-agent taxane is less explored, making this approach somewhat novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital; 2. The clinical stages were T1c, N0, M0; 3. Received treatment in our hospital and had hospitalization records; 4. Has signed and agreed to participate in the PKUPH breast disease cohort study; 5. It is up to the clinician to decide whether to add anthracycline chemotherapy in the adjuvant treatment stage. 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. At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy; 4. Receiving other regimens besides the established neoadjuvant regimens
Where it's running
-
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: yuan peng, doctor
- Email: 13671287670@163.com
- Phone: 86+13671287670
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
BL-M07D1 plus pertuzumab vs standard therapy in first-line HER2-positive breast cancer
A Phase 3 trial tests whether adding BL-M07D1 to pertuzumab is as good as or better than docetaxel plus trastuzumab and pertuzumab in patients with newly diagnosed, unresectable or metastatic HER2-positive breast cancer.
-
IBI354 with or without pertuzumab versus taxane plus trastuzumab and pertuzumab for HER2-positive metastatic breast cancer
This trial tests whether IBI354, with or without pertuzumab, works better than standard taxane plus trastuzumab and pertuzumab as first-line treatment for adults with HER2-positive unresectable locally advanced or metastatic breast cancer.
-
Vaccine targeting HER2 in locally advanced breast cancer
This trial will test a vaccine that boosts the immune system to attack HER2-positive breast cancer in adults with locally advanced or high-risk disease.
-
Treatment for hormone receptor positive HER2 positive breast cancer after neoadjuvant therapy
This study is testing if combining two drugs, trastuzumab and nelatinib, can help people with hormone receptor positive HER2 positive breast cancer who still have cancer after initial treatment feel better compared to the usual combination of trastuzumab and pertuzumab.
-
HER2-targeted vaccine combined with standard chemotherapy for breast cancer
This study is testing if adding a new vaccine to standard chemotherapy can help people with HER2-positive breast cancer have better treatment results.
-
Neoadjuvant therapy with or without Inavolisib for early HER2-positive breast cancer
This study is testing if adding a new drug called Inavolisib to standard treatment can help women with early HER2-positive breast cancer respond better before surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.