Triple Negative Breast CancerNacTNBCNCT06692725
De-escalation of Neoadjuvant Chemotherapy Regimens With Immunotherapy Among TNBC
An observational study of Triple Negative Breast Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Triple Negative Breast Cancer
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: triple negative breast cancer patients who received neoadjuvant chemotherapy based on taxanes combined with carboplatin
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
yuan peng, doctor
shu wang
About this study
Official title: De-escalation of Neoadjuvant Chemotherapy Regimens (Taxane Plus Carboplatin Versus Taxane Plus Carboplatin Sequential Anthracycline) With Immunotherapy Among TNBC
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.
Read the detailed description
Investigators retrospectively recruited 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, TCb combined with immunotherapy, or TCb chemotherapy only) 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.
Inclusion Criteria:
- Patients with triple negative breast cancer diagnosed by biopsy in Peking University People's Hospital;
- The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis);
- Received treatment in our hospital and had hospitalization records;
- Has signed and agreed to participate in the PKUPH breast disease cohort study.
Exclusion Criteria:
- Lack of clinical and pathological data (such as imaging data and pathological data);
- Patients with metastatic breast cancer or bilateral breast cancer;
- At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy;
- Receiving other regimens besides the established neoadjuvant regimens
Primary end point: pathology complete response
- Conditions
- Triple Negative Breast Cancer
- Keywords
- neoadjuvant chemotherapy, De-escalation
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Taxanes combined with carboplatin sequential anthracycline | Paclitaxel, liposome paclitaxel, docetaxel, or albumin paclitaxel combined with carboplatin for 4 cycles, followed by anthracycline combined with cyclophosphamide for 4 cycles, and PD-1 inhibitor was used at the same time | |
| Taxanes combined with carboplatin | paclitaxel, liposome paclitaxel, docetaxel, or albumin paclitaxel combined with carboplatin for 6 cycles, and PD-1 inhibitor was used at the same time |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathology complete response
Postoperative pathology confirmed that the primary breast lesions and axillary lymph nodes had no residual invasive tumor cells (ypT0/is and ypN0)
Measured: 6 months
Secondary outcomes (4)
Invasive disease free survival
the time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.
Measured: 5 years
Disease free survival
the time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.
Measured: 5 years
Breast cancer specific survival
time from study enrollment to death due to breast cancer.
Measured: 5 years
Overall survival
the time from study enrollment to death from any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 380 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Wang, Peking University People's Hospital
- Investigators
- shu wang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692725
- Sponsor's protocol ID
- PKUPH2024Z160
- Acronym
- NacTNBC
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalation of Neoadjuvant Chemotherapy Regimens (Taxane Plus Carboplatin Versus Taxane Plus Carboplatin Sequential Anthracycline) With Immunotherapy Among TNBC
- ClinicalTrials.gov ID
- NCT06692725
- Acronym / sponsor ID
- NacTNBC / PKUPH2024Z160
- Conditions
- Triple Negative Breast Cancer
- Keywords
- neoadjuvant chemotherapy, De-escalation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigators retrospectively recruited 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, TCb combined with immunotherapy, or TCb chemotherapy only) 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.
Inclusion Criteria:
- Patients with triple negative breast cancer diagnosed by biopsy in Peking University People's Hospital;
- The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis);
- Received treatment in our hospital and had hospitalization records;
- Has signed and agreed to participate in the PKUPH breast disease cohort study.
Exclusion Criteria:
- Lack of clinical and pathological data (such as imaging data and pathological data);
- Patients with metastatic breast cancer or bilateral breast cancer;
- At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy;
- Receiving other regimens besides the established neoadjuvant regimens
Primary end point: pathology complete response
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxanes combined with carboplatin sequential anthracycline | – | –Paclitaxel, liposome paclitaxel, docetaxel, or albumin paclitaxel combined with carboplatin for 4 cycles, followed by anthracycline combined with cyclophosphamide for 4 cycles, and PD-1 inhibitor was used at the same time |
| Taxanes combined with carboplatin | – | –paclitaxel, liposome paclitaxel, docetaxel, or albumin paclitaxel combined with carboplatin for 6 cycles, and PD-1 inhibitor was used at the same time |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- triple negative breast cancer patients who received neoadjuvant chemotherapy based on taxanes combined with carboplatin
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pathology complete response
Time frame: 6 months
Postoperative pathology confirmed that the primary breast lesions and axillary lymph nodes had no residual invasive tumor cells (ypT0/is and ypN0)
4 secondary outcomes
Invasive disease free survival
Time frame: 5 years
Disease free survival
Time frame: 5 years
Breast cancer specific survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
shu wang principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuan peng, doctor (86+13671287670, 13671287670@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathology complete response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.