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Zoledronic Acid; Letrozole · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Zoledronic Acid; Letrozole | DRUG | - |
Inclusion Criteria * Postmenopausal women * Newly diagnosed with non metastatic breast cancer * Candidate for mastectomy or breast-conserving surgery Exclusion Criteria * Patients with invasive tumors * Patients receiving anti-cancer treatment * Patients who have undergone surgery Other protocol...
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Zoledronic acid plus letrozole is a combination regimen studied in early breast cancer as neoadjuvant therapy, meaning treatment given before surgery. The combination pairs letrozole, an aromatase inhibitor, with zoledronic acid, a bisphosphonate. It was evaluated in postmenopausal women aged 65 years and older in a Phase 2 study conducted in Canada.
Zoledronic acid inhibits FDPS, or farnesyl diphosphate synthase, an enzyme in the mevalonate pathway. Letrozole is an aromatase inhibitor that lowers estrogen production. Together the regimen combines a bisphosphonate with endocrine therapy in breast cancer. The FDPS target class for zoledronic acid is an inhibitor.
Novartis AG, which trades under the ticker NVS, is the developer associated with the zoledronic acid and letrozole combination in breast cancer. Novartis is the sponsor linked to the clinical development of this regimen.
Zoledronic acid and letrozole is in Phase 2 development for breast cancer. It is investigational and has not been approved for this use. The single registered trial has been completed, and no active trials of this combination are currently listed.
The combination was studied in NCT00247650, titled Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy. This Phase 2 trial enrolled 190 participants, was randomized, was not double blind, and was conducted in Canada. It is now completed.
No. Zoledronic acid and letrozole are two distinct drugs given together in this regimen. Zoledronic acid is a bisphosphonate that inhibits FDPS, while letrozole is an aromatase inhibitor. The Phase 2 breast cancer study compared letrozole alone with letrozole plus zoledronic acid.