Clinical trial · Interventional
Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
A Randomised, Multicenter, Open-label, Phase II Study Evaluating Pyrotinib Plus Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in Early Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2 - Positive Breast Cancer
NCT04398914CI-TRIAL-00057464active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, pertuzumab and 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 Invasive | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EC chemotherapy | Drug | — | UNRESOLVED |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Physician's choice | Drug | — | UNRESOLVED |
| Pyrotinib | Drug | Pyrotinib | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
| T-DM1 | Drug | Trastuzumab Emtansine | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pyrotinib, trastuzumab, pertuzmab and paclitaxel
- description
- Prior to surgery: pyrotinib, trastuzumab, pertuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery： * if non-tpCR：chemotherapy with epirubicin and cyclophosphamide (EC), followed with pertuzumab and trastuzumab up to 1 year total; or T-DM1 for 14 cycles. * if tpCR: chemotherapy 0-4 cycles according to physician's choice, followed with pertuzumab and trastuzumab up to 1 year total.
- interventionNames
- Drug: Pyrotinib
- Drug: Trastuzumab
- Drug: Pertuzumab
- Drug: Nab-paclitaxel
- Drug: EC chemotherapy
- Drug: Physician's choice
- Drug: T-DM1
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Trastuzumab, pertuzmab and paclitaxel
- description
- Prior to surgery: trastuzumab, pertuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery： * if non-tpCR：chemotherapy with epirubicin and cyclophosphamide (EC), followed with pertuzumab and trastuzumab up to 1 year total; or T-DM1 for 14 cycles. * if tpCR: chemotherapy 0-4 cycles according to physician's choice; followed with pertuzumab and trastuzumab up to 1 year total.
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 II-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 * 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, ,Stage I uterine cancer or thyroid papillary microcarcinoma * 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 * Positive serum or urine pregnancy test or above mentioned tests cannot be achieved for women with fertility
References
Publications (0)
Data not yet available
No reference posted for this study.