Clinical trial · Interventional
Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
NCT07506876CI-TRIAL-00110078recruitingPhase 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 usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery. The purpose of this Research Study is to see if taking endocrine therapy with the chemotherapy and HER2 directed therapy increases patients response to therapy at the time of surgery
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 - Infiltrating Ductal Carcinoma | — | UNRESOLVED | — |
| HER-2 Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
- interventionNames
- Drug: Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
Primary outcomes (1)
- measure
- pCR Rates
- timeFrame
- 21 months
- description
- To estimate the rates of pCR in patients receiving neoadjuvant chemotherapy combined with HER2 directed therapy and concurrent endocrine therapy, compared with matched historical controls who received neoadjuvant chemotherapy and HER2 directed therapy alone, stratified by molecularly determined Luminal versus HER2 enriched subtypes
Secondary outcomes (1)
- measure
- RCB scores
- timeFrame
- 21 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines) 1. Endocrine therapy for the current breast cancer may be started within 28 days prior to trial enrollment and must be initiated prior to C2 of chemotherapy/HER2 directed therapy 2. Choice of endocrine therapy will be determined by the treating and/or enrolling physician 2. Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP 3. Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint/BluePrint performed on initial biopsy Exclusion Criteria: 1. Children under 18 years of age, pregnant women, prisoners, and decisionally impaired adults. 2. Patients with non-breast cancer within prior 2 years 3. Patients with breast cancer within prior 5 years 4. Patients with recurrent breast cancer 5. Patients with stage IV breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.