Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

October 6, 2020 updated by: R-Pharm

A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

752

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
      • Cordoba, Argentina
        • Local Institution
      • Neuquen, Argentina
        • Local Institution
      • Santa Fe, Argentina
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina
        • Local Institution
      • Haedo, Buenos Aires, Argentina
        • Local Institution
      • La Plata, Buenos Aires, Argentina
        • Local Institution
      • Mar Del Plata, Buenos Aires, Argentina
        • Local Institution
      • Pilar, Buenos Aires, Argentina
        • Local Institution
      • Quilmes, Buenos Aires, Argentina
        • Local Institution
    • BuenosAires
      • Lanus, BuenosAires, Argentina
        • Local Institution
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Local Institution
  • Belgium
      • Edegem, Belgium
        • Local Institution
      • Gent, Belgium
        • Local Institution
      • Leuven, Belgium
        • Local Institution
      • Liege, Belgium
        • Local Institution
  • Brazil
      • Sao Paulo, Brazil
        • Local Institution
    • Ceara
      • Fortaleza, Ceara, Brazil
        • Local Institution
    • Mina Gerais
      • Belo Horizonte, Mina Gerais, Brazil
        • Local Institution
    • Parana
      • Curitiba, Parana, Brazil
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Local Institution
    • Sao Paulo
      • Jau, Sao Paulo, Brazil
        • Local Institution
      • Santo Andre, Sao Paulo, Brazil
        • Local Institution
      • Sao Paulo - Sp, Sao Paulo, Brazil
        • Local Institution
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Local Institution
    • Ontario
      • Oshawa, Ontario, Canada
        • Local Institution
      • Toronto, Ontario, Canada
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
  • China
      • Beijing, China
        • Local Institution
      • Shanghai, China
        • Local Institution
    • Beijing
      • Beijing, Beijing, China
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, China
        • Local Institution
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Local Institution
    • Shandong
      • Jinan, Shandong, China
        • Local Institution
    • Shanghai
      • Beijing, Shanghai, China
        • Local Institution
    • Shanxi
      • Xi'An, Shanxi, China
        • Local Institution
  • France
      • Angers, France
        • Local Institution
      • Avignon Cedex 2, France
        • Local Institution
      • Bayonne, France
        • Local Institution
      • Besancon, France
        • Local Institution
      • Bobigny, France
        • Local Institution
      • Bordeaux, France
        • Local Institution
      • Clermont-Ferrand, France
        • Local Institution
      • Lyon, France
        • Local Institution
      • Nantes, France
        • Local Institution
      • Nice, France
        • Local Institution
      • Saint Brieuc Cedex, France
        • Local Institution
      • Saint-Cloud Cedex, France
        • Local Institution
      • St. Herblain Cedex, France
        • Local Institution
      • Strasbourg Cedex, France
        • Local Institution
      • Toulouse Cedex 3, France
        • Local Institution
  • Germany
      • Berlin, Germany
        • Local Institution
      • Duisburg, Germany
        • Local Institution
      • Erlangen, Germany
        • Local Institution
  • Greece
      • Athens, Greece
        • Local Institution
      • Thessaloniki, Greece
        • Local Institution
  • Hungary
      • Budapest, Hungary
        • Local Institution
      • Debrecen, Hungary
        • Local Institution
      • Gyor, Hungary
        • Local Institution
      • Pecs, Hungary
        • Local Institution
  • Italy
      • Brescia, Italy
        • Local Institution
      • Candiolo (To), Italy
        • Local Institution
      • Forli, Italy
        • Local Institution
      • San Giovanni Rotondo, Italy
        • Local Institution
  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Local Institution
      • Seoul, Korea, Republic of
        • Local Institution
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Local Institution
    • Negeri Sembilan
      • Nilai, Negeri Sembilan, Malaysia
        • Local Institution
  • Mexico
      • Chihuahua, Mexico
        • Local Institution
      • Distrito Federal, Mexico
        • Local Institution
      • San Luis Potosi, Mexico
        • Local Institution
    • Guerrero
      • Acapulco, Guerrero, Mexico
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico
        • Local Institution
  • Peru
      • Lima, Peru
        • Local Institution
  • Philippines
      • Manila, Philippines
        • Local Institution
      • Quezon, Philippines
        • Local Institution
      • Quezon City, Philippines
        • Local Institution
  • Poland
      • Gdansk, Poland
        • Local Institution
      • Opole, Poland
        • Local Institution
  • Spain
      • Barcelona, Spain
        • Local Institution
      • Girona, Spain
        • Local Institution
      • Madrid, Spain
        • Local Institution
      • Valencia, Spain
        • Local Institution
      • Zaragoza, Spain
        • Local Institution
  • Sweden
      • Gothenburg, Sweden
        • Local Institution
      • Stockholm, Sweden
        • Local Institution
  • Taiwan
      • Tainan, Taiwan
        • Local Institution
      • Taipei, Taiwan
        • Local Institution
  • Thailand
      • Bangkok, Thailand
        • Local Institution
  • United Kingdom
    • Avon
      • Bristol, Avon, United Kingdom
        • Local Institution
    • Essex
      • Chelmsford, Essex, United Kingdom
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom
        • Local Institution
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom
        • Local Institution
    • Surrey
      • Guildford, Surrey, United Kingdom
        • Local Institution
    • Tyne And Wear
      • Newcastle-Upon-Tyne, Tyne And Wear, United Kingdom
        • Local Institution
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • San Francisco, California, United States
        • Local Institution
      • Vallejo, California, United States
        • Local Institution
    • Colorado
      • Denver, Colorado, United States
        • Local Institution
    • Connecticut
      • Hartford, Connecticut, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Orlando, Florida, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • Massachusetts
      • Burlington, Massachusetts, United States
        • Local Institution
    • Mississippi
      • Jackson, Mississippi, United States
        • Local Institution
    • Missouri
      • Columbia, Missouri, United States
        • Local Institution
      • Kansas City, Missouri, United States
        • Local Institution
      • Saint Louis, Missouri, United States
        • Local Institution
    • Nebraska
      • Omaha, Nebraska, United States
        • Local Institution
    • New Jersey
      • Livingston, New Jersey, United States
        • Local Institution
      • New Brunswick, New Jersey, United States
        • Local Institution
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
    • Ohio
      • Columbus, Ohio, United States
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Local Institution
      • Tulsa, Oklahoma, United States
        • Local Institution
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Columbia, South Carolina, United States
        • Local Institution
      • Greenville, South Carolina, United States
        • Local Institution
    • Tennessee
      • Knoxville, Tennessee, United States
        • Local Institution
      • Nashville, Tennessee, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
    • Utah
      • Ogden, Utah, United States
        • Local Institution
    • Vermont
      • Burlington, Vermont, United States
        • Local Institution
    • Washington
      • Tacoma, Washington, United States
        • Local Institution
    • West Virginia
      • Morgantown, West Virginia, 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 either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.
  • Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
  • Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.
  • Patients must be resistant to taxane therapy.
  • Patients may not have any history of brain and/or leptomeningeal metastases.
  • Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).
  • Patients may have not have had prior treatment with an epothilone 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, Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
Experimental: A
Drug: Ixabepilone + Capecitabine

Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity

Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

Other Names:
  • BMS-247550
  • Epothilone
  • IXEMPRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) Per IRRC
Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Participants with best response of "Complete" or "Partial" according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions
based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Duration of Response Per IRRC
Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Computed for all patients with a best response of "Partial" or "Complete" per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death.
based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Time to Response Per IRRC
Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.
based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Overall Survival (OS)
Time Frame: from date of randomization until death
OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.
from date of randomization until death
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

September 1, 2003

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

March 26, 2004

First Submitted That Met QC Criteria

March 29, 2004

First Posted (Estimate)

March 30, 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA163-046

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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