Neoadjuvant Therapies for HER2+ Breast CancerPhase 3NCT04858529
Neoadjuvant TCHP Versus THP in Patients With HER2-positive Breast Cancer (neoCARHP Study)
A Phase 3 study testing investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP) and investigator-selected taxane/trastuzumab/pertuzumab (THP) in people with Neoadjuvant Therapies for HER2+ Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The neoCARHP study was a randomized, open-label, multicenter, phase III, neoadjuvant trial. This study aimed to compare the efficacy and safety of TCHP with THP neoadjuvant setting for HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoadjuvant Therapies for HER2+ Breast Cancer
- What is being tested?
- investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP) and investigator-selected taxane/trastuzumab/pertuzumab (THP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2021to 30 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To take part in the trial, patients must be aged > 18 years old and supply a signed informed consent form.
- Patients must also have breast cancer meeting the following criteria:
- Histologically confirmed invasive breast carcinoma
- Clinical stage II-IIIC at presentation. HER2-positive breast cancer scored as 3+ by immunohistochemistry (IHC) in > 10% of immunoreactive cells, or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals ≥2.0) by in situ hybridization (ISH).
- Known hormone receptor status (ER and PR). Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. Completed all necessary baseline laboratory and radiologic examinations prior to randomization.
- Baseline left ventricular ejection fraction (LVEF)≥55% measured by echocardiography (ECHO).
- Women who are not postmenopausal (≥12 months of amenorrhea) or surgically sterile (absence of ovaries and/or the uterus) must agree to remain abstinent or to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception during the treatment period and for at least 6 months after the last dose of study treatment.
- Clinical diagnosis of Alzheimer's Disease. Must be able to swallow tablets. All patients must be able to comply with the study protocol, according to the investigator's judgment.
Who cannot join
- Stage IV (metastatic) breast cancer Inflammatory breast cancer Previous anti-cancer therapy or radiotherapy for any malignancy. A history of other malignancies, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma.
- Concurrent anti-cancer treatment in another clinical trial, including hormone therapy, bisphosphonate therapy, or immunotherapy.
- Received a major non-breast cancer-related surgical procedure within the 4 weeks before randomization or from which the patient has not fully recovered.
- A serious cardiac illness or medical condition, including but not limited to the following:
- Documented history heart failure or systolic dysfunction (LVEF < 50%). High-risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate >100 bpm at rest, significant ventricular arrhythmia (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AV block).
- Angina pectoris requiring anti-angina medication. Clinically significant valvular heart disease. Evidence of transmural infarction on ECG Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness.
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- Any of the following abnormal laboratory tests immediately prior to randomization:
- Total bilirubin > 1.5 × upper limit of normal (ULN) or, for cases of known Gilbert's syndrome, total bilirubin > 2 × ULN Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.25 × ULN Alkaline phosphatase > 2.5 × ULN Serum creatinine > 1.5 × ULN Total white blood cell (WBC) count < 2500 cells/uL Absolute neutrophil count <1500 cells/uL Platelet count <100,000 cells/uL Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol Pregnant or lactating: a negative serum pregnancy test is required for all women who are not postmenopausal (≥ 12 months of amenorrhea).
- Insulin dependent diabetes. Thyroid disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Kun Wang, Phd, 13922118086, gzwangkun@126.com
About this study
Official title: Neoadjuvant TCHP Versus THP in Patients With Human Epidermal Growth Factor Receptor 2-positive Breast Cancer (neoCARHP) : a Randomized, Open-label, Multicenter, Phase III Trial
The neoCARHP study was a randomized, open-label, multicenter, phase III, neoadjuvant trial. This study aimed to compare the efficacy and safety of TCHP with THP neoadjuvant setting for HER2-positive breast cancer. Patients will be randomized at a 1:1 ratio into TCHP or THP, respectively, and will be treated every 3 weeks before surgery.The primary endpoint was the percentage of pCR (ypT0/is, ypN0), which was defined as the absence of any residual invasive cancer in both the breast and axillary lymph nodes.
- Being tested
- investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP), investigator-selected taxane/trastuzumab/pertuzumab (THP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP)Drug
investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP)
investigator-selected taxane/trastuzumab/pertuzumab (THP)Drug
investigator-selected taxane/trastuzumab/pertuzumab (THP)
| Study group | Role | What they receive |
|---|---|---|
| THP | Experimental | Not described Receives: Drug: investigator-selected taxane/trastuzumab/pertuzumab (THP) |
| TCHP | Active comparator | Not described Receives: Drug: investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response(ypT0/is,ypN0, pCR)
defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0
Measured: 18 weeks
Secondary outcomes (6)
Clinical response during neoadjuvant therapy
Clinical response during neoadjuvant therapy, according to RECIST v1.1.
Measured: 18 weeks
The percentage of patients who underwent breast-conserving surgery
Measured: 18 weeks
Event-free survival (EFS)
Event-free survival (EFS), defined as the time from randomization to the first report of one of the following events:
- Disease progression (before surgery), as determined by the investigator according to RECIST v1.1. Any evidence of in situ contralateral disease will not be identified as progressive disease (PD). Any evidence of invasive contralateral disease will be considered as disease progression
- Disease recurrence (local, regional, distant, or contralateral) after surgery.
- Death from any cause.
Measured: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
Disease-free survival (DFS)
Disease-free survival (DFS), defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of one of the following events:
- Disease recurrence (local, regional, distant, or contralateral) after surgery
- Death from any cause
Measured: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
Safety Outcome Measures
The safety outcome measures for this study are the incidence, type, and severity of adverse events and serious adverse events.
Measured: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
Overall survival, defined as the time from randomization to death from any cause.
Overall survival, defined as the time from randomization to death from any cause.
Measured: from randomization to death from any cause.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start30 Apr 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neoadjuvant Therapies for HER2+ Breast CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 774 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858529
- Sponsor's protocol ID
- 20201101
- Status last verified
- Nov 2023
- First submitted
- 18 Apr 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao HF, Ye GL, Lin Y, Huang Q, Dong J, Cao Y, Zhao YX, Chen QJ, Ma SH, Ouyang J, Ye JH, Yang HW, Zhang YQ, Zhang YC, Zhang GL, Li W, Zhang Y, Wu ZY, Lin YY, Zhu T, Zhang LL, Yang CQ, Yang M, Peng H, Chen B, Chen YT, Ji F, Cheng MY, Li JQ, Jiang Z, Wang K. Neoadjuvant Taxane Plus Trastuzumab and Pertuzumab With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The Randomized Noninferiority Phase III neoCARHP Trial. J Clin Oncol. 2026 Jun 10;44(17):1587-1596. doi: 10.1200/JCO-25-02176. Epub 2026 Jan 23.
PubMed 41576297Zhu T, Huang YH, Li W, Wu CG, Zhang YM, Zheng XX, Zhang TF, Lin YY, Liu ZY, Ye GL, Lin Y, Wu ZY, Wang K. A non-invasive artificial intelligence model for identifying axillary pathological complete response to neoadjuvant chemotherapy in breast cancer: a secondary analysis to multicenter clinical trial. Br J Cancer. 2024 Sep;131(4):692-701. doi: 10.1038/s41416-024-02726-3. Epub 2024 Jun 25.
PubMed 38918556
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant TCHP Versus THP in Patients With Human Epidermal Growth Factor Receptor 2-positive Breast Cancer (neoCARHP) : a Randomized, Open-label, Multicenter, Phase III Trial
- ClinicalTrials.gov ID
- NCT04858529
- Acronym / sponsor ID
- 20201101
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 774 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 26 Apr 2021 (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 neoCARHP study was a randomized, open-label, multicenter, phase III, neoadjuvant trial. This study aimed to compare the efficacy and safety of TCHP with THP neoadjuvant setting for HER2-positive breast cancer. Patients will be randomized at a 1:1 ratio into TCHP or THP, respectively, and will be treated every 3 weeks before surgery.The primary endpoint was the percentage of pCR (ypT0/is, ypN0), which was defined as the absence of any residual invasive cancer in both the breast and axillary lymph nodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THP | Experimental | Drug: investigator-selected taxane/trastuzumab/pertuzumab (THP) |
| TCHP | Active comparator | Drug: investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To take part in the trial, patients must be aged > 18 years old and supply a signed informed consent form.
- Histologically confirmed invasive breast carcinoma
- Clinical stage II-IIIC at presentation. HER2-positive breast cancer scored as 3+ by immunohistochemistry (IHC) in > 10% of immunoreactive cells, or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals ≥2.0) by in situ hybridization (ISH).
- Known hormone receptor status (ER and PR). Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. Completed all necessary baseline laboratory and radiologic examinations prior to randomization.
- Baseline left ventricular ejection fraction (LVEF)≥55% measured by echocardiography (ECHO).
Key exclusion criteria (9 listed)
- Stage IV (metastatic) breast cancer Inflammatory breast cancer Previous anti-cancer therapy or radiotherapy for any malignancy. A history of other malignancies, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma.
- Concurrent anti-cancer treatment in another clinical trial, including hormone therapy, bisphosphonate therapy, or immunotherapy.
- Received a major non-breast cancer-related surgical procedure within the 4 weeks before randomization or from which the patient has not fully recovered.
- A serious cardiac illness or medical condition, including but not limited to the following:
- Documented history heart failure or systolic dysfunction (LVEF < 50%). High-risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate >100 bpm at rest, significant ventricular arrhythmia (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AV block).
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 |
|---|---|---|
| investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP)investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP) | Drug | TCHP |
| investigator-selected taxane/trastuzumab/pertuzumab (THP)investigator-selected taxane/trastuzumab/pertuzumab (THP) | Drug | THP |
Primary outcome
pathological complete response(ypT0/is,ypN0, pCR)
Time frame: 18 weeks
defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0
6 secondary outcomes
Clinical response during neoadjuvant therapy
Time frame: 18 weeks
The percentage of patients who underwent breast-conserving surgery
Time frame: 18 weeks
Event-free survival (EFS)
Time frame: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
Disease-free survival (DFS)
Time frame: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
Safety Outcome Measures
Time frame: until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.
Overall survival, defined as the time from randomization to death from any cause.
Time frame: from randomization to death from any cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 41576297Gao HF, Ye GL, Lin Y, Huang Q, Dong J, Cao Y, Zhao YX, Chen QJ, Ma SH, Ouyang J, Ye JH, Yang HW, Zhang YQ, Zhang YC, Zhang GL, Li W, Zhang Y, Wu ZY, Lin YY, Zhu T, Zhang LL, Yang CQ, Yang M, Peng H, Chen B, Chen YT, Ji F, Cheng MY, Li JQ, Jiang Z, Wang K. Neoadjuvant Taxane Plus Trastuzumab and Pertuzumab With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The Randomized Noninferiority Phase III neoCARHP Trial. J Clin Oncol. 2026 Jun 10;44(17):1587-1596. doi: 10.1200/JCO-25-02176. Epub 2026 Jan 23.
- Derived from this study: PubMed 38918556Zhu T, Huang YH, Li W, Wu CG, Zhang YM, Zheng XX, Zhang TF, Lin YY, Liu ZY, Ye GL, Lin Y, Wu ZY, Wang K. A non-invasive artificial intelligence model for identifying axillary pathological complete response to neoadjuvant chemotherapy in breast cancer: a secondary analysis to multicenter clinical trial. Br J Cancer. 2024 Sep;131(4):692-701. doi: 10.1038/s41416-024-02726-3. Epub 2024 Jun 25.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP) and investigator-selected taxane/trastuzumab/pertuzumab (THP) in people with Neoadjuvant Therapies for HER2+ Breast Cancer, run by Guangdong Provincial 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Wang, Phd (13922118086, gzwangkun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response(ypT0/is,ypN0, pCR) (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04858529, which also lists 2 linked publications.
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 7 Nov 2023.