HER2-positive Breast CancerNacHER2NCT06700369
De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients
An observational study of HER2-positive Breast Cancer, run by Shu Wang at 1 site in China.
Trial summary
Neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (HER2) positive and triple negative breast cancer, which meets the requirements of tumor ≥ 2cm and/or lymph node positive, and the guidelines recommend neoadjuvant… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HER2-positive Breast Cancer
- How many people
- 519 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 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: HER2 positive breast cancer patients who received neoadjuvant chemotherapy based on taxanes with trastuzumab, pertuzumab target therapy
Who may be able to join
- 1) Patients with HER2 positive 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, 86+13671287670
About this study
Official title: De-escalation of Neoadjuvant Chemotherapy Regimens (Taxanes Plus Carboplatin Versus Taxanes Only) With Target Therapy Among HER2 Positive Patients
Neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (HER2) positive and triple negative breast cancer, which meets the requirements of tumor ≥ 2cm and/or lymph node positive, and the guidelines recommend neoadjuvant therapy as the first choice. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Taxane plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxane (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. Considering the defects such as large side effects of combined chemotherapy, whether single drug chemotherapy can be used as the first choice for some people under the support of targeted drugs remains to be studied.
This project plans to a 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 patients with clinical stage T2 and above and/or lymph node positive breast cancer who received neoadjuvant therapy (TCbHP or THP) from January 1, 2015 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. The effectiveness and safety of TCbHP and THP as a neoadjuvant therapy were compared.
- Conditions
- HER2-positive Breast Cancer
- Keywords
- neoadjuvant chemotherapy, De-escalation
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 | Taxane (paclitaxel, liposome paclitaxel, docetaxel, albumin paclitaxel), carboplatin combined with trastuzumab and pertuzumab, 6 cycles in total | |
| Taxanes | Taxane (paclitaxel, liposome paclitaxel, docetaxel, albumin paclitaxel) with trastuzumab and pertuzumab, 6 cycles in total |
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 posted22 Nov 2024
- Study start1 Jan 2015
- Primary completion31 Dec 2028 (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 HER2-positive 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
- 519 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
- Investigators
- shu wang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700369
- Sponsor's protocol ID
- PKUPH2024Z161
- Acronym
- NacHER2
- 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
- De-escalation of Neoadjuvant Chemotherapy Regimens (Taxanes Plus Carboplatin Versus Taxanes Only) With Target Therapy Among HER2 Positive Patients
- ClinicalTrials.gov ID
- NCT06700369
- Acronym / sponsor ID
- NacHER2 / PKUPH2024Z161
- Conditions
- HER2-positive Breast Cancer
- Keywords
- neoadjuvant chemotherapy, De-escalation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 519 participants (estimated)
- Lead sponsor
- Shu WangUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2028 (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.
Neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (HER2) positive and triple negative breast cancer, which meets the requirements of tumor ≥ 2cm and/or lymph node positive, and the guidelines recommend neoadjuvant therapy as the first choice. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Taxane plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxane (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. Considering the defects such as large side effects of combined chemotherapy, whether single drug chemotherapy can be used as the first choice for some people under the support of targeted drugs remains to be studied.
This project plans to a 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 patients with clinical stage T2 and above and/or lymph node positive breast cancer who received neoadjuvant therapy (TCbHP or THP) from January 1, 2015 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. The effectiveness and safety of TCbHP and THP as a neoadjuvant therapy were compared.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxanes combined with carboplatin | – | –Taxane (paclitaxel, liposome paclitaxel, docetaxel, albumin paclitaxel), carboplatin combined with trastuzumab and pertuzumab, 6 cycles in total |
| Taxanes | – | –Taxane (paclitaxel, liposome paclitaxel, docetaxel, albumin paclitaxel) with trastuzumab and pertuzumab, 6 cycles in total |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HER2 positive breast cancer patients who received neoadjuvant chemotherapy based on taxanes with trastuzumab, pertuzumab target therapy
Key inclusion criteria (4 listed)
- 1) Patients with HER2 positive 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 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.
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 HER2-positive 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 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 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?
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 25 Nov 2024.