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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433614
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 17, 2015
Information provided by (Responsible Party):
Thomas Hatschek, Karolinska University Hospital

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Epirubicin Drug: Paclitaxel Drug: Capecitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 Name: 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 Name: Taxol

Drug: Capecitabine
1650 mg/m2 p.o. days 1-14 every 3 weeks study arm B
Other Name: Xeloda

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

  2. Response rate [ Time Frame: Every 9 weeks during treatment ]
  3. 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

  4. 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.

  5. Quality of life [ Time Frame: Baseline, 2, 4, 6 and 9 months ]
    Measured at five points during nine months from randomization.

  6. Tumor biological data related to treatment [ Time Frame: Within two weeks before start of treatment ]
    Fine needle aspirates from metastases

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433614

Sahlgrenska University Hospital
Göteborg, Sweden
Helsingborg Gen. Hospital
Helsingborg, Sweden
Kalmar Central Hospital
Kalmar, Sweden
Karlstad Gen. Hospital
Karlstad, Sweden
Linköping University Hospital
Linköping, Sweden
Lund University Hospital
Lund, Sweden
Malmö General University Hospital
Malmö, Sweden
Sundsvall Gen. Hospital
Sundsvall, Sweden
Norrland University Hospital
Umeå, Sweden
Sponsors and Collaborators
Thomas Hatschek
Principal Investigator: Thomas Hatschek, PhD Karolinska University Hospital

Publications of Results:

Responsible Party: Thomas Hatschek, MD, PhD, Karolinska University Hospital Identifier: NCT01433614     History of Changes
Other Study ID Numbers: TEX trial
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors