# A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

> **NCT02333370** · PHASE1 · COMPLETED · sponsor: **Novartis Pharmaceuticals** · enrollment: 88 (actual)

## Conditions studied

- Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

## Interventions

- **DRUG:** LEE011
- **DRUG:** Letrozole
- **DRUG:** Tamoxifen
- **DRUG:** Fulvestrant
- **DRUG:** goserelin

## Key facts

- **NCT ID:** NCT02333370
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-02-04
- **Primary completion:** 2022-09-29
- **Final completion:** 2022-09-29
- **Target enrollment:** 88 (ACTUAL)
- **Last updated:** 2023-06-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02333370

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02333370, "A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02333370. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*