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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Karolinska University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Thomas Hatschek, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01433614
First received: September 1, 2011
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Drug: Epirubicin
Drug: Paclitaxel
Drug: Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Time to progression [ Time Frame: Every 9 weeks during treatment and every three months after termination of treatment ] [ Designated as safety issue: No ]
    Time to progression comparing treatment with ET vs. TEX in patients with advanced breast cancer.


Secondary Outcome Measures:
  • Time to treatment failure [ Time Frame: Time from date of randomization until treatment disruption ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Every 9 weeks during treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Continuously during treatment and until 2 months after termination ] [ Designated as safety issue: Yes ]
    All side effects which appear during treatment are reported and graded according CTC v.2.

  • Quality of life [ Time Frame: Baseline, 2, 4, 6 and 9 months ] [ Designated as safety issue: No ]
    Measured at five points during nine months from randomization.

  • Tumor biological data related to treatment [ Time Frame: Within two weeks before start of treatment ] [ Designated as safety issue: No ]
    Fine needle aspirates from metastases


Enrollment: 304
Study Start Date: December 2002
Estimated Study Completion Date: March 2012
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epirubicin + paclitaxel (Taxol)
Epirubicin 75mg/m2 i.v., paclitaxel 175 mg/m2 i.v. on day 1 every 21 days.
Drug: Epirubicin
75mg/m2 i.v. every 3 weeks
Drug: Paclitaxel
175 mg/m2 i.v., every 3 weeks arm A 155 mg/m2 i.v., every 3 weeks 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
75mg/m2 i.v. every 3 weeks
Drug: Paclitaxel
175 mg/m2 i.v., every 3 weeks arm A 155 mg/m2 i.v., every 3 weeks arm B
Other Name: Taxol
Drug: Capecitabine
1650 mg/m2 p.o. on days 1-14 every 3 weeks.
Other Name: Xeloda

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433614

Locations
Sweden
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
Investigators
Principal Investigator: Thomas Hatschek, PhD Karolinska University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Hatschek, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01433614     History of Changes
Other Study ID Numbers: TEX trial
Study First Received: September 1, 2011
Last Updated: February 27, 2012
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Capecitabine
Paclitaxel
Fluorouracil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014