Early Breast CancerPhase 2NCT04659499
Nab-paclitaxel in Combination With Pyrotinib in Postoperative Adjuvant Therapy for HER2-positive Breast Cancer
A Phase 2 study testing Nab-paclitaxel in combination with pyrotinib in people with Early Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a multicenter, open-label, single-arm, prospective, phase II study. conducted to evaluate the efficacy, safety and tolerability of nab-paclitaxel plus pyrotinib in patients with lymph node-negative and tumor size ≤3 cm, HER2 positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Early Breast Cancer
- What is being tested?
- Nab-paclitaxel in combination with pyrotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 15 May 2026
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment subjects must have a pathological diagnosis of HER2-positive primary invasive breast cancer with an immunohistochemistry (IHC) score of 3 +, or 2 + and HER2 gene amplification by in situ hybridization (ISH) (ratio of HER2/CEP17 ≥ 2.0).
- The invasive tumor had to measure no more than 3cm and with histologically confirmed lymph node-negative or one lymph node micrometastasis (T ≤ 3 cm, N0/N1mi, M0).
- Tumor should has known ER/PR hormone receptor status.
- All patients must be women above18 years old with Eastern Cooperative Oncology Group score 0 to 1.
- Adequate hematopoietic function and organ function as defined as follows: neutrophil count ≥ 1.5 x 109/L; Platelet count ≥ 90 × 109/L; Hemoglobin ≥ 90 g/L; total bilirubin ≤ 1.5 × ULN; alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN; serum creatinine Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula).
- left ventricular ejection fraction (LVEF) ≥ 50% and Electrocardiogram Fridericia-corrected QT interval (QTcF) ≤ 480 ms.
- Provide written informed consent.
Who cannot join
- Clinical or radiologic evidence of local or regional recurrence of disease or metastatic disease prior to or at the time of study entry.
- Previous treatment with chemotherapeutic drugs, or tyrosine kinase inhibitors targeting HER2 (lapatinib, neratinib or pyrotinib, etc.).
- Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
- Inability to swallow, chronic diarrhea, or intestinal obstruction.
- Known to be allergic to the drug components.
- Have a history of immunodeficiency, including HIV positive, HCV positive, active viral hepatitis B or other immunodeficiency diseases.
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- Have a history of organ transplantation.
- Pregnant, lactating female patients, or female patients who are unwilling to take effective contraceptive.
- Any heart disease, including: (1) arrhythmia; (2) myocardial infarction; (3) heart failure.
- Any other concomitant diseases assessed by investigator as unsuitable for study.
- Previous history of definite neurological or psychiatric disorders.
- Concomitant use of CYP3A4 inhibitors or inducers or drugs that prolong the QT interval.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-label, Single-arm, Phase II Clinical Trial of Nab-paclitaxel in Combination With Pyrotinib in Adjuvant Therapy for Lymph Node-negative and Small Tumor HER2-positive Breast Cancer
This is a multicenter, open-label, single-arm, prospective, phase II study. conducted to evaluate the efficacy, safety and tolerability of nab-paclitaxel plus pyrotinib in patients with lymph node-negative and tumor size ≤3 cm, HER2 positive breast cancer.
- Conditions
- Early Breast Cancer
- Being tested
- Nab-paclitaxel in combination with pyrotinib
- 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-paclitaxel in combination with pyrotinibDrug
Nab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year
| Study group | Role | What they receive |
|---|---|---|
| Nab-paclitaxel in combination with pyrotinib treatment group | Experimental | Nab-paclitaxel 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib 240mg daily for one year Receives: Drug: Nab-paclitaxel in combination with pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year-DFS
3-years-disease free survival rate
Measured: From the start of treatment to 3 years
Secondary outcomes (1)
AEs+SAEs
Adverse Events and Serious Adverse Events are described in terms of CTC AE 5.0
Measured: from the first drug administration to within 28 days for the last pyrotinib dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Jan 2021
- Primary completion15 Feb 2026
- Study completion15 May 2026
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 Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659499
- Sponsor's protocol ID
- MA-BC-II-007
- Status last verified
- Nov 2020
- First submitted
- 2 Dec 2020
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang C, Zhou Y, Lin Y, Mao F, Guan J, Zhang X, Shen S, Wang X, Zhang Y, Pan B, Zhong Y, Peng L, Cao X, Yao R, Zhou X, Xu C, Xu Y, Sun Q. Rationale and design of a phase II trial of pyrotinib in combination with nab-paclitaxel as adjuvant therapy for N0/N1mi, HER2 + early breast cancer (PHAEDRA). BMC Cancer. 2022 Mar 14;22(1):269. doi: 10.1186/s12885-022-09346-1.
PubMed 35287613
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Phase II Clinical Trial of Nab-paclitaxel in Combination With Pyrotinib in Adjuvant Therapy for Lymph Node-negative and Small Tumor HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT04659499
- Acronym / sponsor ID
- MA-BC-II-007
- Conditions
- Early Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 9 Dec 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.
This is a multicenter, open-label, single-arm, prospective, phase II study. conducted to evaluate the efficacy, safety and tolerability of nab-paclitaxel plus pyrotinib in patients with lymph node-negative and tumor size ≤3 cm, HER2 positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nab-paclitaxel in combination with pyrotinib treatment group | Experimental | Drug: Nab-paclitaxel in combination with pyrotinibNab-paclitaxel 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib 240mg daily for one year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrollment subjects must have a pathological diagnosis of HER2-positive primary invasive breast cancer with an immunohistochemistry (IHC) score of 3 +, or 2 + and HER2 gene amplification by in situ hybridization (ISH) (ratio of HER2/CEP17 ≥ 2.0).
- The invasive tumor had to measure no more than 3cm and with histologically confirmed lymph node-negative or one lymph node micrometastasis (T ≤ 3 cm, N0/N1mi, M0).
- Tumor should has known ER/PR hormone receptor status.
- All patients must be women above18 years old with Eastern Cooperative Oncology Group score 0 to 1.
- Adequate hematopoietic function and organ function as defined as follows: neutrophil count ≥ 1.5 x 109/L; Platelet count ≥ 90 × 109/L; Hemoglobin ≥ 90 g/L; total bilirubin ≤ 1.5 × ULN; alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN; serum creatinine Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula).
Key exclusion criteria (12 listed)
- Clinical or radiologic evidence of local or regional recurrence of disease or metastatic disease prior to or at the time of study entry.
- Previous treatment with chemotherapeutic drugs, or tyrosine kinase inhibitors targeting HER2 (lapatinib, neratinib or pyrotinib, etc.).
- Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
- Inability to swallow, chronic diarrhea, or intestinal obstruction.
- Known to be allergic to the drug components.
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 in combination with pyrotinibNab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year | Drug | Nab-paclitaxel in combination with pyrotinib treatment group |
Primary outcome
3-year-DFS
Time frame: From the start of treatment to 3 years
3-years-disease free survival rate
1 secondary outcome
AEs+SAEs
Time frame: from the first drug administration to within 28 days for the last pyrotinib dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 35287613Wang C, Zhou Y, Lin Y, Mao F, Guan J, Zhang X, Shen S, Wang X, Zhang Y, Pan B, Zhong Y, Peng L, Cao X, Yao R, Zhou X, Xu C, Xu Y, Sun Q. Rationale and design of a phase II trial of pyrotinib in combination with nab-paclitaxel as adjuvant therapy for N0/N1mi, HER2 + early breast cancer (PHAEDRA). BMC Cancer. 2022 Mar 14;22(1):269. doi: 10.1186/s12885-022-09346-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-paclitaxel in combination with pyrotinib in people with Early Breast Cancer, run by Peking Union Medical College 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 3 Nov 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year-DFS (time frame: From the start of treatment to 3 years). 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 NCT04659499, 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 3 Nov 2026.