# Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer

> **NCT07729046** · PHASE2 · NOT_YET_RECRUITING · sponsor: **University of California, San Diego** · enrollment: 150 (estimated)

## Conditions studied

- Metastatic Invasive Breast Cancer
- Resistant Breast Cancer
- ER+, HER2-, Metastatic Breast Cancer

## Interventions

- **DRUG:** Neratinib + endocrine therapy
- **DRUG:** Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant
- **DRUG:** CDK4/6 + Endocrine therapy

## Key facts

- **NCT ID:** NCT07729046
- **Lead sponsor:** University of California, San Diego
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2027-07
- **Primary completion:** 2032-05
- **Final completion:** 2035-06
- **Target enrollment:** 150 (ESTIMATED)
- **Last updated:** 2026-07-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07729046

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07729046, "Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer". Retrieved via MORVS 2026-10-21 from https://api.morvs.ai/clinical/NCT07729046. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*