Completed PHASE3 INTERVENTIONAL 2-arm NCT00390455

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

Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

Sponsor: National Cancer Institute (NCI)

Conditions 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 Fulvestrant Laboratory Biomarker Analysis Lapatinib Ditosylate Placebo Administration

Updated 25 times since 2017 Last updated: Dec 9, 2019 Started: Sep 15, 2006 Primary completion: Jul 1, 2014 Completion: Jul 2, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00390455, this PHASE3 trial focuses on Estrogen Receptor Positive and HER2 Positive Breast Carcinoma and remains completed. Sponsored by National Cancer Institute (NCI), it has been updated 25 times since 2006, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

25 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2020 — Jan 2021 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed

▶ Show 20 earlier versions

Dec 2019 — Jan 2020 [monthly]

Active Not Recruiting PHASE3
Nov 2019 — Dec 2019 [monthly]

Active Not Recruiting PHASE3
Oct 2019 — Nov 2019 [monthly]

Active Not Recruiting PHASE3
Sep 2019 — Oct 2019 [monthly]

Active Not Recruiting PHASE3
Aug 2019 — Sep 2019 [monthly]

Active Not Recruiting PHASE3
Jun 2019 — Aug 2019 [monthly]

Active Not Recruiting PHASE3
May 2019 — Jun 2019 [monthly]

Active Not Recruiting PHASE3
Apr 2019 — May 2019 [monthly]

Active Not Recruiting PHASE3
Mar 2019 — Apr 2019 [monthly]

Active Not Recruiting PHASE3
Jan 2019 — Mar 2019 [monthly]

Active Not Recruiting PHASE3
Dec 2018 — Jan 2019 [monthly]

Active Not Recruiting PHASE3
Nov 2018 — Dec 2018 [monthly]

Active Not Recruiting PHASE3
Aug 2018 — Nov 2018 [monthly]

Active Not Recruiting PHASE3
Jul 2018 — Aug 2018 [monthly]

Active Not Recruiting PHASE3
Jun 2018 — Jul 2018 [monthly]

Active Not Recruiting PHASE3
Jul 2017 — Jun 2018 [monthly]

Active Not Recruiting PHASE3
May 2017 — Jul 2017 [monthly]

Active Not Recruiting PHASE3
Apr 2017 — May 2017 [monthly]

Active Not Recruiting PHASE3
Feb 2017 — Apr 2017 [monthly]

Active Not Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE3

First recorded

Sep 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aberdeen, United States , Abington, United States , Akron, United States , Alton, United States , American Fork, United States , Ames, United States , Anderson, United States , Ann Arbor, United States , Anthony, United States , Arroyo Grande, United States and 246 more locations