HER2-positive Breast CancerTaxDHER2NCT06711068
Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy
An observational study of HER2-positive Breast Cancer, run by Shu Wang at 1 site in China.
Trial summary
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HER2-positive Breast Cancer
- How many people
- 8,077 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2031
- How long will I take part?
- 3 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: Invasive breast cancer, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative).
Who may be able to join
- 1) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records;
- 2) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative);
- 3)Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.
Who cannot join
- 1) Lack of clinical pathological data (such as imaging data, pathological data);
- 2) Preoperative neoadjuvant therapy;
- 3) Patients with metastatic breast cancer or bilateral breast cancer;
- 4) Failed to undergo curative surgery.
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: Cohort Study of Adjuvant Chemotherapy Combined With Targeted Therapy for Intermediate Risk HER2 Positive and Lymph Node Negative Early Breast Cancer
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.
- Conditions
- HER2-positive Breast Cancer
- Keywords
- Taxane, target therapy
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 cyclophosphamide chemotherapy | Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel), cyclophosphamide chemotherapy, combined with targeted therapy with trastuzumab, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year | |
| Taxanes chemotherapy | Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel) combined with trastuzumab and pertuzumab targeted therapy, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
The time from 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: 3 years
Secondary outcomes (4)
invasive disease free survival
The time from 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: 3 years
distant disease free survival
The time from enrollment in the study to the occurrence of distant recurrence and metastasis
Measured: 3 years
breast cancer specific survival
Time from enrollment to death due to breast cancer
Measured: 3 years
overall survival
The time from enrollment in the study to death caused by any reason
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 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 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
- 8,077 participants (estimated)
- Target duration
- 3 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
- NCT06711068
- Sponsor's protocol ID
- PKUPH2024Z165
- Acronym
- TaxDHER2
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Adjuvant Chemotherapy Combined With Targeted Therapy for Intermediate Risk HER2 Positive and Lymph Node Negative Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06711068
- Acronym / sponsor ID
- TaxDHER2 / PKUPH2024Z165
- Conditions
- HER2-positive Breast Cancer
- Keywords
- Taxane, target therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,077 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
- 2 Dec 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.
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxanes combined with cyclophosphamide chemotherapy | – | –Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel), cyclophosphamide chemotherapy, combined with targeted therapy with trastuzumab, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year |
| Taxanes chemotherapy | – | –Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel) combined with trastuzumab and pertuzumab targeted therapy, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Invasive breast cancer, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative).
Key inclusion criteria (3 listed)
- 1) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records;
- 2) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative);
- 3)Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.
Key exclusion criteria (4 listed)
- 1) Lack of clinical pathological data (such as imaging data, pathological data);
- 2) Preoperative neoadjuvant therapy;
- 3) Patients with metastatic breast cancer or bilateral breast cancer;
- 4) Failed to undergo curative surgery.
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
disease free survival
Time frame: 3 years
The time from 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: 3 years
distant disease free survival
Time frame: 3 years
breast cancer specific survival
Time frame: 3 years
overall survival
Time frame: 3 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 2 Dec 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 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 3 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 2 Dec 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: 3 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 2 Dec 2024.