Clinical trial · Interventional
Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic 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 drug unavailable
Summary
Brief summary (as posted)
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating postmenopausal women with locally advanced or 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 (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the breast * Locally advanced or metastatic disease * Measurable disease * No bone disease only * No history of brain metastases unless controlled with radiotherapy or surgical resection for ≥ 6 months before study entry * Hormone receptor status: * Estrogen receptor- OR progesterone receptor-positive PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Postmenopausal, as defined by 1 of the following: * Prior bilateral oophorectomy * Prior bilateral ovarian irradiation * No spontaneous menstrual bleeding within the past 12 months * Age 55 and over AND prior hysterectomy without oophorectomy * Age 54 and under AND prior hysterectomy without oophorectomy (or status of ovaries is unknown) AND documented follicle-stimulating hormone level in postmenopausal range Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Granulocyte count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * No prior allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs * No prior allergic reaction to sulfonamides * No active peptic ulcer disease * No active infection * No other medical condition that would preclude study participation * Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for metastatic or recurrent disease Endocrine therapy * No prior endocrine therapy for metastatic disease * Prior adjuvant tamoxifen allowed * No prior aromatase inhibitors * No prior hormonal therapy for recurrent disease * No other concurrent hormonal therapy Radiotherapy * See Disease Characteristics * See Menopausal status * No concurrent radiotherapy Surgery * See Disease Characteristics * See Menopausal status Other * No concurrent fluconazole or lithium * No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other cyclooxygenase-2 inhibitors * Concurrent chronic cardioprotective low-dose aspirin allowed * No other concurrent investigational agents
References
Publications (0)
Data not yet available