Breast CancerPhase 3NCT07057427
Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
A Phase 3 study testing Nab paclitaxel, Docetaxel and Carboplatin and Trastuzumab + Pertuzumab in people with Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined 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
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nab paclitaxel, Docetaxel and Carboplatin and Trastuzumab + Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2025to 30 Jun 2029
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years old.
- Clinical Tumor Stage: T2-T4d, or T1c with axillary lymph node positivity.
- Histologically confirmed HER2-positive invasive breast cancer:
- Note: HER2 positivity is defined as at least one assessment (either initial testing or central review) by the participating center's pathology department demonstrating tumor cells with immunohistochemistry (IHC) staining intensity of 3+ or confirmation by fluorescence in situ hybridization (FISH).
- Clinically measurable disease: Lesion measurable by ultrasound or MRI (optional) within 1 month prior to randomization.
- Adequate organ and bone marrow function within 1 month prior to chemotherapy initiation (no contraindications to chemotherapy):
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- Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L
- Hemoglobin ≥ 100 g/L
- Platelet count ≥ 100 × 10⁹/L
- Total bilirubin < 1.5 × upper limit of normal (ULN)
- Serum creatinine < 1.5 × ULN
- Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < 1.5 × ULN
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55% assessed by echocardiography.
- Women of childbearing potential: Negative serum pregnancy test within 14 days prior to randomization.
- Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Informed consent: Provision of signed written informed consent.
Who cannot join
- Stage IV (metastatic) breast cancer.
- Bilateral breast cancer.
- Prior systemic therapy or radiotherapy for the current breast cancer diagnosis, including chemotherapy, endocrine therapy, or targeted therapy.
- History of a second primary malignancy, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from prior major surgery.
- Significant cardiac disease or dysfunction, including but not limited to:
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- History of congestive heart failure or systolic dysfunction (LVEF < 50%)
- High-risk uncontrolled arrhythmias (e.g., atrial tachycardia, resting heart rate > 100 bpm, clinically significant ventricular arrhythmia [e.g., ventricular tachycardia], or higher-grade atrioventricular block [i.e., Mobitz II second-degree or third-degree heart block])
- Angina pectoris requiring anti-anginal medication
- Clinically significant valvular heart disease
- Electrocardiogram (ECG) evidence of transmural myocardial infarction
- Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
- Presence of any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou, Henan, 450000
Zhenzhen Liu, PHD, 13603862755, zlyyliuzhenzhen0800@zzu.edu.cn
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 evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Nab paclitaxel, Docetaxel and Carboplatin, Trastuzumab + Pertuzumab
- Keywords
- HER2 positive, neoadjuvant therapy, Chemotherapy de-escalation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxelDrug
Nab-paclitaxel (on days 1 and 8 of a 21-day cycle)
Docetaxel and CarboplatinDrug
Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1)
Trastuzumab + PertuzumabDrug
Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nab-PHP group | Experimental | Nab-paclitaxel(on days 1 and 8 of a 21-day cycle) + trastuzumab+ patuzumab (every 3 weeks) Receives: Drug: Nab paclitaxel; Drug: Trastuzumab + Pertuzumab |
| TCbHP | Active comparator | Docetaxel + carboplatin + trastuzumab + patuzumab (every 3 weeks) Receives: Drug: Docetaxel and Carboplatin; Drug: Trastuzumab + Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Measured: through study completion, up to 6 months
Secondary outcomes (7)
Event-Free Survival (EFS)
Measured: 5 years after surgery
Invasive Disease-Free Survival (iDFS)
Measured: 5 years after surgery
Safety-Number of adverse events and serious adverse events.
Measured: up to 1 year
Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs
Measured: up to 1 year
Residual Cancer Burden (RCB)
Proportion of patients with residual cancer burden score of 0-1 after surgery
Measured: up to 6 months
EORTC QLQ-C30 score
quality of life evaluated by EORTC QLQ-C30
Measured: up to 1 year
EORTC QLQ-BR23 score
quality of life evaluated by EORTC QLQ-BR23
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start24 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 812 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057427
- Sponsor's protocol ID
- HELEN-006Lite
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. 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
- NCT07057427
- Acronym / sponsor ID
- HELEN-006Lite
- Conditions
- Breast Cancer
- Keywords
- HER2 positive, neoadjuvant therapy, Chemotherapy de-escalation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 812 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 9 Jul 2025 (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 evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nab-PHP group | Experimental | Drug: Nab paclitaxel, Drug: Trastuzumab + PertuzumabNab-paclitaxel(on days 1 and 8 of a 21-day cycle) + trastuzumab+ patuzumab (every 3 weeks) |
| TCbHP | Active comparator | Drug: Docetaxel and Carboplatin, Drug: Trastuzumab + PertuzumabDocetaxel + carboplatin + trastuzumab + patuzumab (every 3 weeks) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age: 18-70 years old.
- Clinical Tumor Stage: T2-T4d, or T1c with axillary lymph node positivity.
- Note: HER2 positivity is defined as at least one assessment (either initial testing or central review) by the participating center's pathology department demonstrating tumor cells with immunohistochemistry (IHC) staining intensity of 3+ or confirmation by fluorescence in situ hybridization (FISH).
- Clinically measurable disease: Lesion measurable by ultrasound or MRI (optional) within 1 month prior to randomization.
- Adequate organ and bone marrow function within 1 month prior to chemotherapy initiation (no contraindications to chemotherapy):
Key exclusion criteria (14 listed)
- Stage IV (metastatic) breast cancer.
- Bilateral breast cancer.
- Prior systemic therapy or radiotherapy for the current breast cancer diagnosis, including chemotherapy, endocrine therapy, or targeted therapy.
- History of a second primary malignancy, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from prior major surgery.
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 paclitaxelNab-paclitaxel (on days 1 and 8 of a 21-day cycle) | Drug | Nab-PHP group |
| Docetaxel and CarboplatinDocetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1) | Drug | TCbHP |
| Trastuzumab + PertuzumabTrastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks. | Drug | Nab-PHP group, TCbHP |
Primary outcome
Pathological Complete Response (pCR)
Time frame: through study completion, up to 6 months
7 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: up to 1 year
Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs
Time frame: up to 1 year
Residual Cancer Burden (RCB)
Time frame: up to 6 months
EORTC QLQ-C30 score
Time frame: up to 1 year
EORTC QLQ-BR23 score
Time frame: up to 1 year
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 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 3 study testing Nab paclitaxel, Docetaxel and Carboplatin and Trastuzumab + Pertuzumab in people with Breast Cancer, 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 16 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. 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?
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 Zhenzhen Liu, PHD (13603862755, zlyyliuzhenzhen0800@zzu.edu.cn), 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, up to 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 9 Jul 2025.