Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

October 6, 2020 updated by: R-Pharm

A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1221

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution
      • Mendoza, Argentina
        • Local Institution
      • Salta, Argentina
        • Local Institution
      • Santa Fe, Argentina
        • Local Institution
    • Buenos Aires
      • Avelianeda, Buenos Aires, Argentina
        • Local Institution
      • Bahia Blanca, Buenos Aires, Argentina
        • Local Institution
      • Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
        • Local Institution
      • Escobar, Buenos Aires, Argentina
        • Local Institution
    • Chaco
      • Resistencia, Chaco, Argentina
        • Local Institution
    • Cordoba
      • Barrio Alto Verde, Cordoba, Argentina
        • Local Institution
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina
        • Local Institution
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Local Institution
      • Westmead, New South Wales, Australia
        • Local Institution
    • Queensland
      • Brisbane, Queensland, Australia
        • Local Institution
      • Herston, Queensland, Australia
        • Local Institution
      • South Brisbane, Queensland, Australia
        • Local Institution
      • Toowoomba, Queensland, Australia
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia
        • Local Institution
      • Woodville, South Australia, Australia
        • Local Institution
    • Victoria
      • East Melbourne, Victoria, Australia
        • Local Institution
      • Parkville, Victoria, Australia
        • Local Institution
    • Western Australia
      • Perth, Western Australia, Australia
        • Local Institution
  • Austria
      • Graz, Austria
        • Local Institution
      • Voecklabruck, Austria
        • Local Institution
      • Wien, Austria
        • Local Institution
  • Belgium
      • Bruxelles, Belgium
        • Local Institution
      • Charleroi, Belgium
        • Local Institution
      • Gent, Belgium
        • Local Institution
      • Hasselt, Belgium
        • Local Institution
      • Kortrijk, Belgium
        • Local Institution
      • Wilrijk, Belgium
        • Local Institution
  • Brazil
      • Rio De Janeiro, Brazil
        • Local Institution
    • Rio Grande Do Sul
      • Centro-Porto Alegre, Rio Grande Do Sul, Brazil
        • Local Institution
    • Sao Paulo
      • Bela Vista, Sao Paulo, Brazil
        • Local Institution
      • Higienopolis, Sao Paulo, Brazil
        • Local Institution
    • Sp
      • Sao Paulo, Sp, Brazil
        • Local Institution
  • Canada
    • Ontario
      • Thunder Bay, Ontario, Canada
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • Local Institution
  • China
    • Beijing
      • Beijing, Beijing, China
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, China
        • Local Institution
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Local Institution
    • Liaoning
      • Dalian, Liaoning, China
        • Local Institution
      • Dilian, Liaoning, China
        • Local Institution
    • Shandong
      • Jinan, Shandong, China
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, China
        • Local Institution
    • Shanxi
      • Xi'An, Shanxi, China
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Local Institution
  • Croatia
      • Split, Croatia
        • Local Institution
      • Zagreb, Croatia
        • Local Institution
  • Czechia
      • Brno, Czechia
        • Local Institution
      • Hradec Kralove, Czechia
        • Local Institution
      • Prague, Czechia
        • Local Institution
      • Prague 5, Czechia
        • Local Institution
  • Denmark
      • Aalborg, Denmark
        • Local Institution
      • Herlev, Denmark
        • Local Institution
      • Kobenhavn O, Denmark
        • Local Institution
  • France
      • Angers, France
        • Local Institution
      • Bordeaux, France
        • Local Institution
      • Caen, France
        • Local Institution
      • Clermont-Ferrand, France
        • Local Institution
      • Colmar, France
        • Local Institution
      • Le Mans, France
        • Local Institution
      • Metz, France
        • Local Institution
      • Paris Cedex 13, France
        • Local Institution
      • Pierre Benite, France
        • Local Institution
      • Reims, France
        • Local Institution
      • Saint Brieuc, France
        • Local Institution
      • Saint Gregoire, France
        • Local Institution
      • Saint Herblain, France
        • Local Institution
      • Tours Cedex, France
        • Local Institution
      • Villejuif Cedex, France
        • Local Institution
  • Germany
      • Berlin, Germany
        • Local Institution
      • Erlangen, Germany
        • Local Institution
      • Essen, Germany
        • Local Institution
      • Hannover, Germany
        • Local Institution
      • Karlsruhe, Germany
        • Local Institution
      • Kiel, Germany
        • Local Institution
      • Marburg, Germany
        • Local Institution
      • Munchen, Germany
        • Local Institution
      • Rehling, Germany
        • Local Institution
      • Saarbrucken, Germany
        • Local Institution
      • Tubingen, Germany
        • Local Institution
      • Ulm, Germany
        • Local Institution
      • Wiesbaden, Germany
        • Local Institution
  • Greece
      • Athens, Greece
        • Local Institution
      • Crete, Greece
        • Local Institution
      • Patras, Greece
        • Local Institution
      • Thessaloniki, Greece
        • Local Institution
  • Ireland
      • Cork, Ireland
        • Local Institution
      • Dublin, Ireland
        • Local Institution
      • Dublin 8, Ireland
        • Local Institution
      • Dublin 9, Ireland
        • Local Institution
      • Galway, Ireland
        • Local Institution
    • Cork
      • Wilton, Cork, Ireland
        • Local Institution
  • Israel
      • Haifa, Israel
        • Local Institution
      • Jerusalem, Israel
        • Local Institution
      • Ramat-Gan, Israel
        • Local Institution
      • Tel Aviv, Israel
        • Local Institution
  • Italy
      • Bari, Italy
        • Local Institution
      • Firenze, Italy
        • Local Institution
      • Genova, Italy
        • Local Institution
      • Milano, Italy
        • Local Institution
      • Modena, Italy
        • Local Institution
      • Perugia, Italy
        • Local Institution
      • Potenza, Italy
        • Local Institution
      • Roma, Italy
        • Local Institution
      • San Giovanni Rotondo, Italy
        • Local Institution
      • Sora, Italy
        • Local Institution
      • Torino, Italy
        • Local Institution
    • Milan
      • Rozzano, Milan, Italy
        • Local Institution
  • Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of
        • Local Institution
      • Incheon, Korea, Republic of
        • Local Institution
      • Seoul, Korea, Republic of
        • Local Institution
  • Netherlands
      • Arnhem, Netherlands
        • Local Institution
      • Den Haag, Netherlands
        • Local Institution
      • Enschede, Netherlands
        • Local Institution
      • Zwolle, Netherlands
        • Local Institution
  • Portugal
      • Coimbra, Portugal
        • Local Institution
      • Lisboa, Portugal
        • Local Institution
  • Russian Federation
      • Kazan, Russian Federation
        • Local Institution
      • Moscow, Russian Federation
        • Local Institution
      • St. Petersburg, Russian Federation
        • Local Institution
  • Singapore
      • Singapore, Singapore
        • Local Institution
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa
        • Local Institution
    • Gauteng
      • Johannesburg, Gauteng, South Africa
        • Local Institution
      • Pretoria, Gauteng, South Africa
        • Local Institution
    • Western Cape
      • Panorama, Western Cape, South Africa
        • Local Institution
  • Spain
      • Barcelona, Spain
        • Local Institution
      • Cadiz, Spain
        • Local Institution
      • Cordoba, Spain
        • Local Institution
      • Elche (Alicante), Spain
        • Local Institution
      • Hospitalet De Llobregat, Spain
        • Local Institution
      • Jaen, Spain
        • Local Institution
      • Madrid, Spain
        • Local Institution
      • Pontevedra, Spain
        • Local Institution
      • Reus, Spain
        • Local Institution
      • Salamanca, Spain
        • Local Institution
      • Sevilla, Spain
        • Local Institution
      • Tenerife, Spain
        • Local Institution
      • Valencia, Spain
        • Local Institution
      • Zaragoza, Spain
        • Local Institution
    • Barcelona
      • Terassa, Barcelona, Spain
        • Local Institution
  • Switzerland
      • Bern, Switzerland
        • Local Institution
      • Thun, Switzerland
        • Local Institution
      • Zurich, Switzerland
        • Local Institution
  • Taiwan
      • Taipei, Taiwan
        • Local Institution
  • Turkey
      • Ankara, Turkey
        • Local Institution
      • Istanbul, Turkey
        • Local Institution
      • Izmir, Turkey
        • Local Institution
  • United Kingdom
    • Armagh
      • Belfast, Armagh, United Kingdom
        • Local Institution
    • Central
      • Glasgow, Central, United Kingdom
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom
        • Local Institution
    • Shropshire
      • Shrewsbury, Shropshire, United Kingdom
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Local Institution
  • United States
    • Arizona
      • Tucson, Arizona, United States
        • Local Institution
    • California
      • Beverly Hills, California, United States
        • Local Institution
      • Corona, California, United States
        • Local Institution
    • Connecticut
      • Hartford, Connecticut, United States
        • Local Institution
    • Florida
      • Plantation, Florida, United States
        • Local Institution
    • Idaho
      • Boise, Idaho, United States
        • Local Institution
    • Illinois
      • Evanston, Illinois, United States
        • Local Institution
    • Iowa
      • Iowa City, Iowa, United States
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States
        • Local Institution
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Local Institution
    • Maryland
      • Bethesda, Maryland, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • Mississippi
      • Jackson, Mississippi, United States
        • Local Institution
    • Missouri
      • Columbia, Missouri, United States
        • Local Institution
    • New Jersey
      • Voorhees, New Jersey, United States
        • Local Institution
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Local Institution
    • New York
      • Bronx, New York, United States
        • Local Institution
      • Latham, New York, United States
        • Local Institution
      • Mineola, New York, United States
        • Local Institution
      • New York, New York, United States
        • Local Institution
    • North Carolina
      • Durham, North Carolina, United States
        • Local Institution
      • Goldsboro, North Carolina, United States
        • Local Institution
      • Hickory, North Carolina, United States
        • Local Institution
      • Kinston, North Carolina, United States
        • Local Institution
    • Ohio
      • Canton, Ohio, United States
        • Local Institution
      • Columbus, Ohio, United States
        • Local Institution
    • Pennsylvania
      • Langhorne, Pennsylvania, United States
        • Local Institution
    • Tennessee
      • Knoxville, Tennessee, United States
        • Local Institution
      • Memphis, Tennessee, United States
        • Local Institution
    • Texas
      • Dallas, Texas, United States
        • Local Institution
    • Virginia
      • Charlottesville, Virginia, United States
        • Local Institution
      • Norfolk, Virginia, United States
        • Local Institution
      • Richmond, Virginia, United States
        • Local Institution
    • Wisconsin
      • Marshfield, Wisconsin, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
  • Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.
  • Patients may not have any history of brain and/or leptomeningeal metastases.
  • Patients may not have Grade 2 or worse neuropathy at the time of study entry.
  • Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: Capecitabine
Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle
Experimental: A
Drug: Ixabepilone + Capecitabine
Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
Other Names:
  • Epothilone
  • IXEMPRA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: from date of randomization until death
Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.
from date of randomization until death

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.
every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Response Rate (RR)
Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants
every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Duration of Response
Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method.
every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Time to Response
Time Frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure).
every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Treatment-Related Safety Summary
Time Frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.
Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0
safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Time Frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment
Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.
Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Pharm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 7, 2004

First Submitted That Met QC Criteria

May 10, 2004

First Posted (Estimate)

May 11, 2004

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA163-048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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