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Completed Phase 3 Interventional Results available

Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

ClinicalTrials.gov ID: NCT01234337

Public ClinicalTrials.gov record NCT01234337. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 29, 2026, 9:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

Study identification

NCT ID
NCT01234337
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bayer
Industry
Enrollment
537 participants

Conditions and interventions

Conditions

Interventions

  • Capecitabine Drug
  • Placebo Drug
  • Sorafenib (Nexavar, BAY43-9006) Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 20, 2011
Primary completion
May 11, 2014
Completion
Oct 19, 2017
Last update posted
Nov 5, 2018

2011 – 2017

United States locations

U.S. sites
19
U.S. states
16
U.S. cities
18
Facility City State ZIP Site status
Not listed Greenbrae California 94904-2007
Not listed Sylmar California 91342
Not listed West Palm Beach Florida 33407
Not listed Joliet Illinois 60435
Not listed Evansville Indiana 47713
Not listed Louisville Kentucky 40207
Not listed Boston Massachusetts 02114
Not listed Boston Massachusetts 02115-6084
Not listed Jackson Mississippi 39202
Not listed Springfield Missouri 65804
Not listed Albuquerque New Mexico 87131
Not listed Lake Success New York 11042
Not listed Durham North Carolina 27710
Not listed Philadelphia Pennsylvania 19104
Not listed Bristol Tennessee 37620
Not listed Memphis Tennessee 38120
Not listed El Paso Texas 79905
Not listed Burlington Vermont 05405
Not listed Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 134 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01234337, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 5, 2018 · Synced Apr 29, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01234337 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →