Clinical trial · Interventional
Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
NCT03497702CI-TRIAL-00032509NeoChAIunknownPhase 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 an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.
Conditions
Conditions (2)
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 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| leuprorelin | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Patients receive neoadjuvant chemotherapy (doxorubicin 60mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 every 3 weeks for 4 cycles followed by docetaxel 75mg/m2 IV on day 1 every 3 weeks for 4 cycles) plus letrozole with or without leuproelin depending on menopausal status
- interventionNames
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Docetaxel
- Drug: Letrozole
- Drug: leuprorelin
Primary outcomes (1)
- measure
- pathologic complete remission (pCR)
- timeFrame
- within 6 weeks following the last dose of chemotherapy
- description
- pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 \[MD Anderson definition\])
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven breast cancer patients who are candidate of neoadjuvant chemotherapy with AC followed by Docetaxel * Age: 19-70 years * ER or PR positive ,cT2-3N0 or cT1-3/N+ M0 (ER-positive ≥1% nuclear staining by immunohistochemistry , Allred score≥3 ) * Available FFPE tissue for biomarker study * HER2-negative by ASCO/CAP guideline * Patients who agree to adequate contraception * ECOG scores of 0-2 * Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions * Patients who provide consent Exclusion Criteria: * Inflammatory breast cancer * Distant metastasis * Cerebral vascular accidents including transient ischemic attack * Pulmanary thromboembolism or deep vein thrombosis with 6 months; however, patients who received more than 6 weeks of anticoagulation within 6 months and remains asymptomatic are eligible. * With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, curatively resected early gastric cancer, differentiated thyoid cancer \< 1 cm, or other cured malignant tumor without recurrence for at least 3 years * Ejection Fraction \<55% by MUGA scan / Echo CG * No available tissue for biomarker study * Pregnant or lactating women * Patients with other serious diseases or medical conditions: Pituitary adenoma, Malabsorption syndrome, Major resection of gastrointestinal tract, Corrected QT interval \> 480 msec, Congestive heart failure or unstable angina pectoris, myocardial infarction, stent insertion, angioplasty, coronary bypass surgery, symptomatic peripheral artery disease within 6 months before the enrollment * NYHA class III or IV congestive heart failure * Uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator * Major surgery, major trauma, and/or unhealed wound, fracture, or ulcer within 4 weeks * Acute hemorrhage or hemorrhagic tendency * Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases which may affect the understanding and sign of the informed consent * Uncontrolled acute infection * Patients with allergic constitution and any known or suspected drug allergy * Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study * Patients with mental illness or other conditions affecting the patient compliance * Not suitable for the trial considered by the investigator
References
Publications (0)
Data not yet available
No reference posted for this study.