Clinical trial · Interventional
Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years. Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen), is a drug that is FDA approved. It has been shown to reduce the risk of breast cancer recurrence in postmenopausal women with breast cancer who have been previously treated with tamoxifen. Letrozole works by stopping the production of estrogen in parts of the body other than the ovaries. Leuprolide is a drug that stops a women's ovarian cycles. This process is known as ovarian function suppression. Stopping a women's menstrual cycle may be effective against breast cancer for some patients when given as initial therapy. The combination of letrozole and leuprolide is considered a standard treatment for women with metastatic breast cancer, and is also sometimes used for treatment of premenopausal early stage breast cancer, but it has not been accepted as a standard of care treatment.
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 |
|---|---|---|---|
| letrozole | Drug | Letrozole | ALIAS |
| leuprolide | Drug | Leuprolide | ALIAS |
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Letrozole-Leuprolide
- description
- Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.
- interventionNames
- Drug: leuprolide
- Drug: letrozole
- Drug: zoledronic acid
Primary outcomes (1)
- measure
- Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.
- timeFrame
- 1 year
- description
- The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18 years of age or older * History of invasive ER+ or PR+ breast cancer treated with at least 4.5 years of tamoxifen * No current evidence of recurrent invasive disease or metastatic disease. Patients may have a history of bilateral breast cancer * Premenopausal (estradiol level in premenopausal range, \>20pg/ml, within the prior 28 days) * Liver function tests and creatinine \<2.5 times the upper limit of normal within the 28 days prior to enrollment * ECOG Performance Status 0-1 * Must agree to use non-hormonal contraception (condoms, diaphragm, IUD, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped * Negative pregnancy test within 14 days prior to enrollment * Patient must be able to speak, read and write in English Exclusion Criteria: * Previous treatment with an oral or IV bisphosphonate in the prior two years * History of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix * Women with evidence of current local recurrence or metastatic breast cancer * Pregnant women * Nursing women * Women who are currently taking tamoxifen and are unwilling to stop this medication * Women with a known deleterious BRCA 1 or BRCA 2 mutation
References
Publications (0)
Data not yet available