# Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive

> **NCT00390455** · PHASE3 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 295 (actual)

## Conditions studied

- Estrogen Receptor Positive
- HER2 Positive Breast Carcinoma
- HER2/Neu Negative
- Progesterone Receptor Positive
- Recurrent Breast Carcinoma
- Stage IIIB Breast Cancer AJCC v7
- Stage IIIC Breast Cancer AJCC v7
- Stage IV Breast Cancer AJCC v6 and v7

## Interventions

- **DRUG:** Fulvestrant
- **OTHER:** Laboratory Biomarker Analysis
- **DRUG:** Lapatinib Ditosylate
- **OTHER:** Placebo Administration

## Key facts

- **NCT ID:** NCT00390455
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2006-09-15
- **Primary completion:** 2014-07-01
- **Final completion:** 2014-07-02
- **Target enrollment:** 295 (ACTUAL)
- **Last updated:** 2019-12-20


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00390455

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00390455, "Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT00390455. Licensed CC0.

---

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