Clinical trial · Interventional
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
Phase II Open-label, Multicentre, Exploratory Trial of Neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
NCT04997798CI-TRIAL-00064068unknownPhase 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 is a phase II open-label, multicenter trial assessing the efficacy of combination regimen"Dalpiciclib plus Exemestane plus trastuzumab plus pyrotinib"in early triple positive breast cancer patients.
Conditions
Conditions (3)
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 |
| Estrogen Receptor Positive Tumor | Breast Neoplasm | PROBABILISTIC | 0.70 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab Pyrotinib Exemestane Dalpiciclib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dalpiciclib in combination with exemestane and trastuzumab plus pyrotinib
- description
- Patients are treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21，Q4W) and Exemestane (25 mg po QD ）and oral pyrotinib (320 mg po QD) for 20 weeks.
- interventionNames
- Drug: Trastuzumab Pyrotinib Exemestane Dalpiciclib
Primary outcomes (1)
- measure
- pathological complete response (pCR)
- timeFrame
- at surgery
- description
- Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery
Secondary outcomes (2)
- measure
- Serial measures of Ki67
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 Years to 75 Years * Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer, staging criteria is to be based on AJCC 7. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Primary tumor must have positive estrogen receptor (ER) ≥10% * Primary tumor must be HER2-positive (IHC 3+ or FISH/CISH amplification) * Baseline LVEF ≥50% measured by Echocardiography (preferred) or MUGA scan * Normal organ and marrow function * Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization. * Baseline corrected QT interval (QTcF) \< 480 ms * All patients must be female. Exclusion Criteria: * Inflammatory breast cancer * Evidence of bilateral invasive breast cancer or metastatic disease * Received any prior treatment for primary invasive breast cancer * Pregnant or lactating women * Abnormal baseline hematological values: * Abnormal baseline liver function, bilirubin, creatinine and/or INR (international normalized ratio) * Subjects with known infection with HIV, HBV, HCV * Other investigational drugs while on study * Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease. * Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.