NCT06692725Recruiting
De-escalation of Neoadjuvant Chemotherapy Regimens With Immunotherapy Among TNBC
De-escalation of Neoadjuvant Chemotherapy Regimens (Taxane Plus Carboplatin Versus Taxane Plus Carboplatin Sequential Anthracycline) With Immunotherapy Among TNBC
Source: ClinicalTrials.gov · Last updated 20 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The traditional neoadjuvant therapy for triple negative breast cancer is based on anthracycline, paclitaxel and carboplatin. Nowadays, immunotherapy combined with chemotherapy has become a new standard treatment, which not only benefits from pathological complete response (pCR), but also benefits from long-term survival. The standard chemotherapy combined with immunotherapy scheme recommended by the guidelines is TCb-AC combined with pabolizumab, but the complex chemotherapy scheme has the defects of long cycle and large adverse reactions, and the scheme of chemotherapy reduction has been explored. This project plans to adopt an ambispective cohort study, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and retrospectively include the triple negative breast cancer patients with clinical stage T2 and above and/or lymph node positive who received neoadjuvant therapy (TCb-AC combined with immunotherapy, or TCb combined with immunotherapy) admitted to the center from January 1, 2019 to November 31, 2024. Patients of the same type from December 1, 2024 to December 31, 2028 were prospectively included. The efficacy and safety of different treatment regimens were compared.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 380 (estimated)
- First submitted
- 14 Nov 2024
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Peking University People's Hospital
- NCT number
- NCT06692725
What you commit to
- Study type: Observational
- Planned participants: 380
- From 1 Jan 2019 to the primary completion date, 31 Dec 2028
- 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
- 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
Other illness
- 2\) Patients with metastatic breast cancer or bilateral breast cancer;
Other
- 1\) Lack of clinical and pathological data (such as imaging data and pathological data);
Who the study is looking for
- 1\) Patients with triple negative breast cancer diagnosed by biopsy in Peking University People's Hospital;
- 2\) The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis);
- 3\) Received treatment in our hospital and had hospitalization records;
- 4\) 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. 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.