Breast Cancer,HER2-positivePhase 3NCT04547907
A Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
A Phase 3 study testing Nab-paclitaxel+ trastuzumab+ patuzumab and Docetaxel+ carboplatin+ trastuzumab + patuzumab in people with Breast Cancer,HER2-positive, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer,HER2-positive
- What is being tested?
- Nab-paclitaxel+ trastuzumab+ patuzumab and Docetaxel+ carboplatin+ trastuzumab + patuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2020to 31 Dec 2024
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years;
- Clinical T2-T4d, or T1c with axillary lymph node positivity;
- Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+ or, if IHC 2+, by HER2 gene amplification as demonstrated by fluorescence in situ hybridization (FISH) assay；
- Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization;
- No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy:
- Neutrophil count absolute value ≧2.0×109/L;
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- Hemoglobin ≧ 100g/L;
- Platelet count ≧100×109/L;
- Total bilirubin <1.5 ULN (upper limit of normal);
- Creatinine < 1.5×ULN
- AST/ALT < 1.5×ULN;
- Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%);
- Reproductive age women, negative serum pregnancy test within 14 days before randomization;
- ECOG score 0 or 1;
- Signature of informed consent.
Who cannot join
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease;
- Patients with a second primary malignancy, except for adequately treated skin cancer;
- Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such surgical procedures;
- Severe heart disease or conditions that do not allow participation in the study, including but not limited to the following:
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- History of heart failure or systolic dysfunction (LVEF < 50%);
- High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-grade atrioventricular conduction blocks (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);
- Angina pectoris requiring anti-anginal drug therapy;
- Clinically significant valvular heart disease;
- ECG showing a transmural myocardial infarction;
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg);
- Due to severe and uncontrolled other medical conditions, the investigator considers chemotherapy to be contraindicated;
- Known history of allergy to any component of the study drugs; patients with a history of immune deficiency diseases, including HIV positivity, or patients with other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou, Henan
Zhenzhen Liu, 17729798130, liuzhenzhen73@126.com
About this study
Official title: Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial
The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
Read the detailed description
In order to compare the effects of nab-PHP and TCbHP chemotherapy regimens in the neoadjuvant treatment of HER2-positive breast cancer, this study randomly divided patients who met the inclusion criteria into 2 groups through a randomized control regimen： the neoadjuvant chemotherapy with 6*nab-PHP regimen group (experimental group): nab-paclitaxel 125mg/m2 on days 1, 8, and 15 every 21 days as one cycle; 6*TCbHP regimen (control group): docetaxel 75 mg/m2 + carboplatin (AUC=6) on day 1. Both groups will receive trastuzumab (loading dose 8 mg/kg followed by a maintenance dose of 6 mg/kg) on day 1 and pertuzumab (loading dose 840 mg followed by a maintenance dose of 420 mg) on day 1, every 21 days as one cycle.
Surgery will be performed after completion of neoadjuvant chemotherapy, with intraoperative excision of specimens (breast + axilla) for pathological evaluation.
Comparative analysis of pCR, EFS, iDFS and safety outcomes between the two groups will be conducted using appropriate statistical methods.
Safety evaluation will include the incidence of adverse events, incidence of serious adverse events, dose adjustment rate, and discontinuation rate.
- Conditions
- Breast Cancer,HER2-positive
- Being tested
- Nab-paclitaxel+ trastuzumab+ patuzumab, Docetaxel+ carboplatin+ trastuzumab + patuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxel+ trastuzumab+ patuzumabDrug
Also called nab-PHP regimen group
Nab-paclitaxel 125mg/m2 (days 1, 8, 15) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.
Docetaxel+ carboplatin+ trastuzumab + patuzumabDrug
Also called TCbHP regimen group
Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.
| Study group | Role | What they receive |
|---|---|---|
| nab-PHP | Experimental | Nab-paclitaxel + trastuzumab+ patuzumab Receives: Drug: Nab-paclitaxel+ trastuzumab+ patuzumab |
| TCbHP | Active comparator | Docetaxel + carboplatin + trastuzumab + patuzumab Receives: Drug: Docetaxel+ carboplatin+ trastuzumab + patuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Pathological Complete Response (pCR) rate: It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Event-Free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: disease progression during neoadjuvant treatment, disease recurrence, or any cause of death.
Measured: 5 years after surgery
Invasive Disease-Free Survival (iDFS)
This refers to the time from surgery to the first documented occurrence of an event such as ipsilateral invasive breast tumour recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.
Measured: 5 years after surgery
Safety-Number of adverse events and serious adverse events.
Safety will be assessed by evaluating the nature, incidence, and severity of chemotherapy-related adverse events according to CTCAE 4.0 (Common Terminology Criteria for Adverse Events).
Measured: After each cycle of chemotherapy (21 days as 1 cycle)
Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs
Tolerability will be assessed by evaluating the dose adjustment rate and discontinuation rate of chemotherapy drugs in both treatment regimens.
Measured: After the end of the 6th cycle of chemotherapy (21 days as 1 cycle)
Exploratory endpoint - Differences in pCR rates between predefined subgroups and factors influencing pCR in the study population.
The differences in pCR rate between various predefined subgroups and the factors affecting pCR in the enrolled population will be explored.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start18 Sep 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer,HER2-positiveStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Model description
- An open-label, multicenter, randomized controlled phase III clinical study. Neoadjuvant chemotherapy with 6\*nab-PHP regimen (experimental group): 344 subjects. Neoadjuvant chemotherapy with 6\*TCbHP regimen (control group): 344 subjects.
- Masking
- None (open label)
- Enrolment
- 688 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, Principal investigator, Study Principal Investigator Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547907
- Sponsor's protocol ID
- HELEN-006
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2020
- Last updated
- 20 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen XC, Jiao DC, Qiao JH, Wang CZ, Sun XF, Lu ZD, Li LF, Zhang CJ, Yan M, Wei Y, Chen B, Feng YQ, Deng M, Ma MD, Plichta JK, He YW, Liu ZZ. De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab versus docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive early breast cancer (HELEN-006): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2025 Jan;26(1):27-36. doi: 10.1016/S1470-2045(24)00581-3. Epub 2024 Nov 26.
PubMed 39612919
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Nab-PHP and TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer, A Multicenter, Randomized, Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT04547907
- Acronym / sponsor ID
- HELEN-006
- Conditions
- Breast Cancer,HER2-positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 688 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Sep 2020 (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 aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
Detailed description
In order to compare the effects of nab-PHP and TCbHP chemotherapy regimens in the neoadjuvant treatment of HER2-positive breast cancer, this study randomly divided patients who met the inclusion criteria into 2 groups through a randomized control regimen： the neoadjuvant chemotherapy with 6*nab-PHP regimen group (experimental group): nab-paclitaxel 125mg/m2 on days 1, 8, and 15 every 21 days as one cycle; 6*TCbHP regimen (control group): docetaxel 75 mg/m2 + carboplatin (AUC=6) on day 1. Both groups will receive trastuzumab (loading dose 8 mg/kg followed by a maintenance dose of 6 mg/kg) on day 1 and pertuzumab (loading dose 840 mg followed by a maintenance dose of 420 mg) on day 1, every 21 days as one cycle.
Surgery will be performed after completion of neoadjuvant chemotherapy, with intraoperative excision of specimens (breast + axilla) for pathological evaluation.
Comparative analysis of pCR, EFS, iDFS and safety outcomes between the two groups will be conducted using appropriate statistical methods.
Safety evaluation will include the incidence of adverse events, incidence of serious adverse events, dose adjustment rate, and discontinuation rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, multicenter, randomized controlled phase III clinical study. Neoadjuvant chemotherapy with 6*nab-PHP regimen (experimental group): 344 subjects. Neoadjuvant chemotherapy with 6*TCbHP regimen (control group): 344 subjects.
| Arm | Type | Receives |
|---|---|---|
| nab-PHP | Experimental | Drug: Nab-paclitaxel+ trastuzumab+ patuzumabNab-paclitaxel + trastuzumab+ patuzumab |
| TCbHP | Active comparator | Drug: Docetaxel+ carboplatin+ trastuzumab + patuzumabDocetaxel + carboplatin + trastuzumab + patuzumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age: 18-70 years;
- Clinical T2-T4d, or T1c with axillary lymph node positivity;
- Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+ or, if IHC 2+, by HER2 gene amplification as demonstrated by fluorescence in situ hybridization (FISH) assay；
- Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization;
- No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy:
Key exclusion criteria (14 listed)
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease;
- Patients with a second primary malignancy, except for adequately treated skin cancer;
- Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such surgical procedures;
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 |
|---|---|---|
| Nab-paclitaxel+ trastuzumab+ patuzumabAlso: nab-PHP regimen groupNab-paclitaxel 125mg/m2 (days 1, 8, 15) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle. | Drug | nab-PHP |
| Docetaxel+ carboplatin+ trastuzumab + patuzumabAlso: TCbHP regimen groupDocetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle. | Drug | TCbHP |
Primary outcome
Pathological Complete Response (pCR)
Time frame: through study completion, an average of 1 year
Pathological Complete Response (pCR) rate: It refers to the absence of any invasive cancer in the resected specimens (breast + axilla) after completion of neoadjuvant chemotherapy and surgery (i.e., ypT0/is, ypN0).
5 secondary outcomes
Event-Free Survival (EFS)
Time frame: 5 years after surgery
Invasive Disease-Free Survival (iDFS)
Time frame: 5 years after surgery
Safety-Number of adverse events and serious adverse events.
Time frame: After each cycle of chemotherapy (21 days as 1 cycle)
Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs
Time frame: After the end of the 6th cycle of chemotherapy (21 days as 1 cycle)
Exploratory endpoint - Differences in pCR rates between predefined subgroups and factors influencing pCR in the study population.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 39612919Chen XC, Jiao DC, Qiao JH, Wang CZ, Sun XF, Lu ZD, Li LF, Zhang CJ, Yan M, Wei Y, Chen B, Feng YQ, Deng M, Ma MD, Plichta JK, He YW, Liu ZZ. De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab versus docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive early breast cancer (HELEN-006): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2025 Jan;26(1):27-36. doi: 10.1016/S1470-2045(24)00581-3. Epub 2024 Nov 26.
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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.
Zhenzhen Liu principal investigator
Study Principal Investigator Henan Cancer Hospital
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 Nab-paclitaxel+ trastuzumab+ patuzumab and Docetaxel+ carboplatin+ trastuzumab + patuzumab in people with Breast Cancer,HER2-positive, run by Henan Cancer 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 15 inclusion and 14 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 20 Sep 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.
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 Zhenzhen Liu (13603862755, liuzhenzhen73@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: through study completion, an average of 1 year). 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 NCT04547907, which also lists 1 linked publication.
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 Sep 2024.