Clinical trial · Interventional
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
A Randomised, Multicenter, Open-label, Phase II Study Evaluating Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in Early Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2 - Positive Breast Cancer
NCT04066790CI-TRIAL-00045147terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We terminated this trial and initiated a new one including pertuzumab.
Summary
Brief summary (as posted)
This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EC chemotherapy | Drug | — | UNRESOLVED |
| nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Pyrotinib | Drug | Pyrotinib | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pyrotinib in combination with nab-paclitaxel
- description
- Prior to surgery: pyrotinib and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.
- interventionNames
- Drug: Pyrotinib
- Drug: nab-Paclitaxel
- Drug: Trastuzumab
- Drug: EC chemotherapy
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Trastuzumab in combination with nab-paclitaxel
- description
- Prior to surgery: trastuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with epirubicin and cyclophosphamide (EC): trastuzumab up to 1 year total.
- interventionNames
- Drug: nab-Paclitaxel
- Drug: Trastuzumab
- Drug: EC chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * With signed consent * Histologically confirmed invasive breast carcinoma with a primary tumor size of no less than (≥) 2 centimeters (cm) by standard local assessment technique * Breast cancer stage at presentation: stage I-III * HER2-positive breast cancer defined as 3+ score by immunohistochemistry in \> 10 percent (%) of immunoreactive cells or HER2 gene amplification by in situ hybridization * Known hormone receptor status (estrogen receptor and/or progesterone receptor) * Eastern Cooperative Oncology Group Performance Status equal to or less than (\<=) 1 * Baseline left ventricular ejection fracture \>= 50% measured by echocardiography * Willing to use highly effective form of nonhormonal contraception while on study and for 7 months after end of study treatment for female with fertility or male * Negative serum pregnancy test for women with fertility * Willing to obey the study protocol Exclusion Criteria: * Stage IV disease * Previous anti-cancer therapy or radiotherapy for any malignancy * History of other malignancy within 5 years prior to screening, except for appropriately-treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer * Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy * Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered * Serious cardiac illness or medical condition * Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness * Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization * Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol * Not able to swallow the drug * Pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.