Clinical trial · Interventional
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
A Phase II Trial of Preoperative HER2 Targeting and Endocrine Therapy in Postmenopausal Women With HER2 and HR Positive Breast Cancer
NCT02214004CI-TRIAL-00031689HERAKLESunknownPhase 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)
The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab and Letrozole
- description
- \- Concurrently initiate two drugs on Day 1 of Cycle 1
- interventionNames
- Drug: Trastuzumab
- Drug: Letrozole
Primary outcomes (1)
- measure
- The rate of pathologic complete response
- timeFrame
- At time of surgery
- description
- No residual invasive cancer in breast regardless of axilla
Secondary outcomes (6)
- measure
- Clinical Response Rate
- timeFrame
- At time of surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Invasive cancer (clinical stage IB-IIIC)
* Measurable tumor larger than 1cm
* ECOG status 0 or 1
* Postmenopausal women
* Age ≥55 years and amenorrhea
* Age \<55 years and amenorrhea for ≥12 months with FSH \>30 mIU/ml
* HER2 positive tumor
* 3 positive on IHC
* 2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
* Estrogen receptor positive tumor
* Positive ER expression with Allred score more than PS3/TS8 or modified Allred score more than PS4/TS7
* Eligible cardiac function
* Normal heard evaluated by ECG
* Consider clinically non-significant arrythmia and ischemic change as normal
* LVEF ≥ 55% measured by ECHO or MUGA scan
Exclusion Criteria:
* Inflammatory breast cancer
* Bilateral breast cancer
* Patients with previous breast cancer history
* Patients with previous breast cancer treatment: Generally include hormone therapy, chemotherapy, and radiotherapy)
* Patients having uncontrolled heart problems
* Ischemic heart disease within 6 months
* Congestive heart failure more than NYHA class II
* Unstable angina
* Clinically significant pericarditis
* Amyloid heart diseaseReferences
Publications (0)
Data not yet available
No reference posted for this study.