Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
| Condition | Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7 |
|---|---|
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Status | Active, not recruiting |
| Enrollment | 81 participants |
| Interventions | Endoxifen Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Tamoxifen Citrate |
| Start date | May 28, 2015 |
| Completion date | Nov 6, 2020 |
| Results posted | Sep 28, 2021 |
Summary
This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating patients with breast cancer.
Progression Free Survival (PFS)
| Arm I (Z-endoxifen Hydrochloride) | 130 days |
|---|---|
| Arm II (Tamoxifen Citrate) | 42 days |
Open in BENITIONS View on ClinicalTrials.gov
Other trials for this condition
- Vitamin D and Physical Activity on Bone Health — University of Rochester
- Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in T — National Cancer Institute (NCI)
- Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor — National Cancer Institute (NCI)
- A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Can — AstraZeneca
- Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information: Adm — University of Colorado, Denver
- Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer — National Cancer Institute (NCI)