Phase 2
N=16
Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00903162 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole. — 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- leuprolide (Drug); letrozole (Drug); zoledronic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole. |
4 | — |
| SECONDARY Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density. |
— | — |
| SECONDARY The Effect of OFS Combined With Aromatase Inhibitor Therapy on the Incidence and Severity of Menopausal Symptoms, Sexual Dysfunction, Musculoskeletal Complaints, Other Side Effects and Overall Quality of Life. |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00903162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.