CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 118 enrolled
Drug / intervention
Bortezomib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01142401
NCT01142401Phase 2Completed

A Randomized Phase II Study of Fulvestrant vs. Fulvestrant in Combination With Bortezomib in Women With ER Positive Metastatic Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Jun 11, 2010·Updated Nov 27, 2023

In Brief

A Phase 2 clinical trial evaluating Bortezomib, Fulvestrant, and 1 other intervention for Metastatic Breast Carcinoma and 3 related conditions. Completed, enrolled 118 participants across 21 sites.

Detailed Summary

This randomized phase II trial studies how well fulvestrant works with or without bortezomib in treating patients with estrogen receptor positive breast cancer that has spread to other places in the body and cannot be removed by surgery. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Bortezomib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. It is not yet known whether fulvestrant is more effective with or without bortezomib in treating breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2010
Enrollment StartMay 26, 2010
Primary CompletionJul 30, 2015
Study CompletionJan 8, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.1 years ago

Interventions

Bortezomibdrug

Given IV

Fulvestrantdrug

Given IM

Laboratory Biomarker Analysisother

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