Epirubicin and Paclitaxel, Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer (TEX)

September 16, 2015 updated by: Thomas Hatschek

Treatment With the Combination of Epirubicin and Paclitaxel Alone or Together With Capecitabine as First Line Treatment in Metastatic Breast Cancer. A Multicenter, Randomized Phase III Study

Anthracycline-taxane regimens are effective means of postponing progression in metastatic breast cancer. It is yet unclear whether addition of capecitabine to this combination improves the treatment outcome.

Patients with advanced breast cancer are randomized to first-line chemotherapy with a combination of epirubicin (Farmorubicin®) and paclitaxel (Taxol®) alone (ET) or in combination with capecitabine (Xeloda®, TEX). Starting doses for ET are epirubicin 75 mg/m2 plus paclitaxel 175 mg/m2, and for TEX epirubicin 75mg/m2, paclitaxel 155 mg/m2, and capecitabine 825 mg/m2 BID for 14 days. Subsequently, doses are tailored related to side effects.

Primary endpoint is progression-free survival (PFS); secondary endpoints are overall survival (OS), time to treatment failure (TTF), objective response (OR), safety and quality of life (QoL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

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

  • Sweden
      • Göteborg, Sweden
        • Sahlgrenska University Hospital
      • Helsingborg, Sweden
        • Helsingborg Gen. Hospital
      • Kalmar, Sweden
        • Kalmar Central Hospital
      • Karlstad, Sweden
        • Karlstad Gen. Hospital
      • Linköping, Sweden
        • Linköping University Hospital
      • Lund, Sweden
        • Lund University Hospital
      • Malmö, Sweden
        • Malmö General University Hospital
      • Sundsvall, Sweden
        • Sundsvall Gen. Hospital
      • Umeå, Sweden
        • Norrland University Hospital

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

Inclusion Criteria:

  • Morphologically proven breast carcinoma
  • Written patient consent must be obtained
  • Measurable disease (i.e. at least one lesion that can be accurately measured in at least one dimension as ≥20 mm by conventional techniques, or as ≥10 mm by spiral CT scan) as defined in section 8.
  • Lytic and blastic bone metastases as only site of recurrence are allowed
  • Age 18 years or older
  • ECOG performance status 0-2
  • Life expectancy of at least three months
  • Adequate cardiac functions
  • Adequate hematological, renal and hepatic functions
  • Patient must be accessible for treatment and follow-up.

Exclusion Criteria:

  • Treatment-free interval less than one year, if previous adjuvant, neoadjuvant or after radically treated locoregional recurrence given regimen contained anthracycline, taxane or capecitabine. This limitation does not apply for regimens containing other than the drugs mentioned
  • During adjuvant treatment obtained cumulative doses exceeding 375 mg/m2 for doxorubicin, or 550 mg/m2 for epirubicin, abnormal ECG or reduced cardiac function measured by left ventricular ejection fraction (LVEF).
  • Indication for the use of trastuzumab (Herceptin) as first-line treatment in patients with tumor overexpressing c-erbB2.
  • Any previous chemotherapy for metastatic disease, except for radically treated locoregional relapse
  • Neoplasm other than breast carcinoma, except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix, diagnosed during the past five years
  • Pregnancy or lactation
  • Known brain metastases
  • History of atrial or ventricular arrhythmias and/or congestive heart failure, even if medically controlled. History of clinical and electrocardiographically documented myocardial infarction
  • Preexisting motor or sensory neuropathy ≥ grade 2 according to NCI CTC 2.0 criteria (severe paresthesia and/or mild weakness, or worse)
  • Severe hepatic or renal impairment (for capecitabine: calculated creatinine clearance below 30 ml/min; for calculation, see p. 5.1.4) not allowing for adequate use of the proposed regimens
  • History of known dihydropyrimidine dehydrogenase (DPD) deficiency (severe reaction on previous treatment with fluorouracil, e.g experience of mucositis, hand-foot syndrome, or diarrhea)
  • Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide, cyclosporin or vitamin K
  • Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.

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: Epirubicin + paclitaxel (Taxol)
Epirubicin 75mg/m2 i.v., paclitaxel 175 mg/m2 i.v. on day 1 every 21 days.
Drug: Epirubicin
75 mg/m2 i.v. every 3 weeks, both study arms
Drug: Paclitaxel
175 mg/m2 i.v., every 3 weeks study arm A 155 mg/m2 i.v., every 3 weeks study arm B
Other Names:
  • Taxol
Active Comparator: Paclitaxel + epirubicin + capecitabine
Paclitaxel 155 mg/m2 i.v., epirubicin 75 mg/m2 i.v day 1, capecitabine 1650 mg/m2 p.o. on days 1-14 every 21 days.
Drug: Epirubicin
75 mg/m2 i.v. every 3 weeks, both study arms
Drug: Paclitaxel
175 mg/m2 i.v., every 3 weeks study arm A 155 mg/m2 i.v., every 3 weeks study arm B
Other Names:
  • Taxol
Drug: Capecitabine
1650 mg/m2 p.o. days 1-14 every 3 weeks study arm B
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: From date of randomisation until date of first radiolocically documented progression or death from any cause, whichever comes first up to 78 months
Time to progression comparing treatment with ET vs. TEX in patients with advanced breast cancer. Evaluation every 9 weeks during treatment until progression as long as study treatment was given, and every 12 weeks until date of progression, if treatment was disrupted for any other reason. Patients in the state of persistent complete response after primary completion date were reported only upon date of progression or death up to 78 months
From date of randomisation until date of first radiolocically documented progression or death from any cause, whichever comes first up to 78 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to treatment failure
Time Frame: From date of randomization until date of treatment disruption for any reason up to 78 months
Time on treatment irrespective of reason for disruption (toxicity, patients wish)
From date of randomization until date of treatment disruption for any reason up to 78 months
Response rate
Time Frame: Every 9 weeks during treatment
Every 9 weeks during treatment
Overall survival
Time Frame: Time from randomisation until date of death up to 78 months
Date and cause of death reported yearly during the ongoing trial, up to 78 months after primary completion date only on the occasion of death
Time from randomisation until date of death up to 78 months
Number of participants with adverse events
Time Frame: Continuously during treatment and until 2 months after termination
All side effects which appear during treatment are reported and graded according CTC v.2.
Continuously during treatment and until 2 months after termination
Quality of life
Time Frame: Baseline, 2, 4, 6 and 9 months
Measured at five points during nine months from randomization.
Baseline, 2, 4, 6 and 9 months
Tumor biological data related to treatment
Time Frame: Within two weeks before start of treatment
Fine needle aspirates from metastases
Within two weeks before start of treatment

Collaborators and Investigators

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

Sponsor

Thomas Hatschek

Investigators

  • Principal Investigator: Thomas Hatschek, PhD, Karolinska University Hospital

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

December 1, 2002

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 1, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (Estimate)

September 14, 2011

Study Record Updates

Last Update Posted (Estimate)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEX trial

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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