# National Cancer Institute (NCI): Phase 1 study started recruiting, 36 planned (Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8)

**Score:** 35/100

| Field | Value |
|---|---|
| Sponsor | National Cancer Institute (NCI) |
| Sponsor type | NIH |
| Study | Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer |
| NCT ID | NCT07137416 |
| Phase | Phase 1 |
| Status | recruiting |
| Conditions | Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Invasive Breast Carcinoma; Locally Advanced Breast Carcinoma; Metastatic Breast Carcinoma; Metastatic HER2-Low Breast Carcinoma |
| Intervention types | procedure, drug, biological |
| Target enrollment | 36 |
| Site countries | United States |
| Posted | 2025-08-22 |
| Planned start | 2026-10-06 |
| Event | Started recruiting |
| Event date | 2026-10-06 |
| Last update posted | 2026-10-16 |

## Why this score
- Just started recruiting: sites, recruitment and supply are active.

Source: ClinicalTrials.gov (U.S. National Library of Medicine) API v2 (https://clinicaltrials.gov/study/NCT07137416). Last refreshed: 2026-11-05T08:46:16.625Z.
From public ClinicalTrials.gov registrations. Sponsor and study level only: we never list investigators, contacts or participants. A registration describes a planned study and can change. Status changes are read from each study's current status, actual dates and latest posted update, not a full change history, so an update can be a correction rather than a new change. Verify on ClinicalTrials.gov.