NCT04836156 Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for Human Epidermal Growth Factor Receptor 2 (HER2) Negative Early Breast Cancer Patients
| NCT ID | NCT04836156 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | HER2-negative Early Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2021-04-02 |
| Primary Completion | 2022-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 46 participants in total. It began in 2021-04-02 with a primary completion date of 2022-06-30.
⚠ 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
Neoadjuvant treatment is an important treatment for early breast cancer patients. Patients with triple negative subtype who achieved pCR after neoadjuvant treatment would have longer survival. The neoadjuvant treatment for her2 negative patient was chemotherapy with combined drugs. However, not all patients benefit from chemotherapy but suffer from chemotherapy-related side effects. It was unknown for a patient who could benefit from which drug before chemotherapy. Drug sensitivity screening in vitro was a promising method for choosing chemotherapy. But there was no method could select effective drugs accurately for breast cancer patients until now. Previously, investigators developed a patient-derived tumor-like cell clusters in vitro culture technology. Feasibility for guiding clinical treatment by drug sensitivity screening based on this technology have been explored by preliminary exploration with a well corresponding. And the results have been published. This study will explore whether drug screening in vitro patient-derived tumor-like cell clusters from breast cancer tissue could be a method for selection of chemotherapy for her2 negative participants.
Eligibility Criteria
Inclusion Criteria: * invasive breast cancer * HER2 negative * T2 or node positive * Eastern Cooperative Oncology Group(ECOG) 0-1 Exclusion Criteria: * stage IV * inflammatory breast cancer * Severe chronic disease
Contact & Investigator
Shu Wang, doctor
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT04836156 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying HER2-negative Early Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04836156 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04836156 currently recruiting?
Yes, NCT04836156 is actively recruiting participants. Contact the research team at hzwcb1990@163.com for enrollment information.
Where is the NCT04836156 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04836156 clinical trial?
NCT04836156 is sponsored by Peking University People's Hospital. The principal investigator is Shu Wang, doctor at Peking University People's Hospital. The trial plans to enroll 46 participants.
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