Triple Negative Breast CancerNeoTNBCXNCT06700382
Different Methods of Capecitabine in Patients With Non-PCR After Neoadjuvant Therapy for TNBC
An observational study of Triple Negative Breast Cancer, run by Shu Wang at 1 site in China.
Trial summary
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 patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- capecitabine
- How many people
- 1,166 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2031
- 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 patients, non-PCR after neoadjuvant therapy
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 stages before treatment were T1-T4, N0-N3, M0;
- 3) Received treatment and operation in our hospital, and had hospitalization records;
- 4) Neoadjuvant chemotherapy is unlimited, and immunotherapy is allowed in neoadjuvant and/or adjuvant treatment;
- 5) Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or axillary lymph nodes;
- 6) 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) Failure to perform radical surgery;
- 4) BRCA has pathogenic or possibly pathogenic mutations, and received intensive treatment with PARP inhibitors after operation
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, Dr
shu wang
About this study
Official title: A Cohort Study of Different Methods of Adjuvant Capecitabine Regimens in Patients With Non-PCR After Neoadjuvant Therapy for Triple Negative Breast Cancer
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 patients. Therefore, studies have confirmed that intensive adjuvant therapy for patients with non-pCR after neoadjuvant chemotherapy can further improve the survival of this population. Previous studies have given capecitabine treatment to such patients as standard. However, it is unknown whether capecitabine intensification still has the same status under the premise that most patients receive immunotherapy at the neoadjuvant stage; Whether there are differences in the efficacy and safety of capecitabine standard 6-8 cycle intensive regimen and capecitabine metronomic chemotherapy are practical problems encountered in clinical practice. This study explored the efficacy and safety of 6-8 cycles of full dose capecitabine intensive therapy compared with 1-year capecitabine metronomic chemotherapy in patients with T2 and above and/or lymph node positive early triple negative breast cancer who still had invasive tumor after neoadjuvant therapy.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- capecitabine
- Keywords
- neoadjuvant chemotherapy, adjuvant chemotherapy, non-pCR, capecitabine
- 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.
capecitabineDrug
different methods of treatment for capecitabine
| Study group | Role | What they receive |
|---|---|---|
| 6-8 cycles full dose capecitabine | 6-8 cycles of full dose capecitabine intensive therapy (1250mg/m2, BID,D1-D14,Q3W) Receives: Drug: capecitabine | |
| 1-year metronomic capecitabine | 1-year capecitabine metronomic chemotherapy (650mg/m2,BID) Receives: Drug: capecitabine | |
| no other chemotherapy | no other chemotherapy besides neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
distant disease free survival
Time from study enrollment to distant recurrence and metastasis
Measured: 5 years
breast cancer specific survival
Time from study enrollment to death due to breast cancer
Measured: 5 years
overall survival
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 posted22 Nov 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (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.
- 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
- 1,166 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shu Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shu Wang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700382
- Sponsor's protocol ID
- PKUPH2024Z167
- Acronym
- NeoTNBCX
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 25 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Different Methods of Adjuvant Capecitabine Regimens in Patients With Non-PCR After Neoadjuvant Therapy for Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06700382
- Acronym / sponsor ID
- NeoTNBCX / PKUPH2024Z167
- Conditions
- Triple Negative Breast Cancer
- Keywords
- neoadjuvant chemotherapy, adjuvant chemotherapy, non-pCR, capecitabine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,166 participants (estimated)
- Lead sponsor
- Shu WangUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 22 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 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 patients. Therefore, studies have confirmed that intensive adjuvant therapy for patients with non-pCR after neoadjuvant chemotherapy can further improve the survival of this population. Previous studies have given capecitabine treatment to such patients as standard. However, it is unknown whether capecitabine intensification still has the same status under the premise that most patients receive immunotherapy at the neoadjuvant stage; Whether there are differences in the efficacy and safety of capecitabine standard 6-8 cycle intensive regimen and capecitabine metronomic chemotherapy are practical problems encountered in clinical practice. This study explored the efficacy and safety of 6-8 cycles of full dose capecitabine intensive therapy compared with 1-year capecitabine metronomic chemotherapy in patients with T2 and above and/or lymph node positive early triple negative breast cancer who still had invasive tumor after neoadjuvant therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6-8 cycles full dose capecitabine | – | Drug: capecitabine6-8 cycles of full dose capecitabine intensive therapy (1250mg/m2, BID,D1-D14,Q3W) |
| 1-year metronomic capecitabine | – | Drug: capecitabine1-year capecitabine metronomic chemotherapy (650mg/m2,BID) |
| no other chemotherapy | – | –no other chemotherapy besides neoadjuvant therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Triple negative patients, non-PCR after neoadjuvant therapy
Key inclusion criteria (6 listed)
- 1) Patients with triple negative breast cancer 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) Neoadjuvant chemotherapy is unlimited, and immunotherapy is allowed in neoadjuvant and/or adjuvant treatment;
- 5) Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or axillary lymph nodes;
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) Failure to perform radical surgery;
- 4) BRCA has pathogenic or possibly pathogenic mutations, and received intensive treatment with PARP inhibitors after operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabinedifferent methods of treatment for capecitabine | Drug | 1-year metronomic capecitabine, 6-8 cycles full dose capecitabine |
Primary outcome
disease free survival
Time frame: 5 years
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.
4 secondary outcomes
invasive disease free survival
Time frame: 5 years
distant 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 25 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.
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 Shu Wang 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 6 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 25 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?
disease free survival (time frame: 5 years). 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 25 Nov 2024.