Clinical trial · Interventional
Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer
A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated due to lack of accrual
Summary
Brief summary (as posted)
RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA together with letrozole may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given together with letrozole in treating patients with metastatic 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DHEA | Drug | — | UNRESOLVED |
| letrozole | Drug | Letrozole | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Dose-limiting toxicity
- timeFrame
- One year from drug start
- description
- Subjects will be monitored at day 14 and then every 2 weeks for up to one year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Metastatic disease * Hormone receptor status * Estrogen receptor- and progesterone receptor-negative * Androgen receptor-positive PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Postmenopausal (\> 60 years of age) * Leukocyte count \> 3,000/uL * Absolute neutrophil count \> 1,500/uL * Platelet count \> 100,000/uL * Total bilirubin normal * AST and ALT \< 2.5 times upper limit of normal * Creatinine normal OR creatinine clearance \> 60 mL/min PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior chemotherapy * At least 4 weeks since prior biologic therapy * At least 4 weeks since prior radiotherapy * At least 30 days since prior investigational agents * No concurrent dehydroepiandrosterone or androstenedione supplements * No concurrent chemotherapy or radiotherapy * No concurrent hormone therapy or immunotherapy (including trastuzumab \[Herceptin®\])
References
Publications (0)
Data not yet available