TBP Study With Capecitabine Plus Minus Trastuzumab

NCT00148876 | Completed Phase 3 DMC

• 2 other identifiers: GBG 26BIG3-05
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

Brief Summary

This study is done in patients having Breast Cancer with metastasis (patients with positive receptor HER2) whose disease progressed after receiving Trastuzumab. The primary objective of this study is to compare the time until disease progression between the Treatment Arm CAPECITABINE and the Treatment Arm CAPECITABINE + TRASTUZUMAB The study has also other secondary and tertiary objectives.

Conditions

Breast Cancer

Keywords

Progression after treatment with Trastuzumab; Metastatic Breast Cancer; Palliative Study

Outcome Measures

Primary Outcomes (1)

• Any progression of disease or disease related death of a patient

Secondary Outcomes (5)

• Any response documented according to the RECIST Criteria

• Time from CR or PR until progression of disease or death due to any cause

• Any response and stable disease of >24 weeks duration documented according to the RECIST Criteria

• Any grade III/IV toxicity (NCI-CTC version2.0).Premature treatment discontinuation

• Any death of a patient

Study Arms (2)

Capecitabine

ACTIVE COMPARATOR

Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression and discontinuation of Trastuzumab.

Drug: Capecitabine

Capecitabine and Trastuzumab

EXPERIMENTAL

Capecitabine 2500 mg/m² orally day 1-14 q day 22 until progression + Trastuzumab 6 mg/kg body weight every 3 weeks i.v. as a 90 min infusion until progression

Drug: Capecitabine; Drug: Trastuzumab

Interventions

Capecitabine DRUG

Capecitabine 2500 mg/m² orally day 1-14 q day 22

Capecitabine; Capecitabine and Trastuzumab

Trastuzumab DRUG

Trastuzumab 6 mg/kg body weight every 3 weeks i.v.

Capecitabine and Trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
• Pathologically confirmed carcinoma of the breast.
• Locally advanced or metastatic stage of disease not suitable for surgery or radiotherapy alone.
• HER2-overexpression of the primary or metastatic tumor tissue detected by immunohistochemistry (DAKO) 3+ or gene namplification detected by FISH. HER2-positive primary tumours with HER2-negative metastasis can be included.
• Disease progression during or after previous chemotherapy and trastuzumab treatment as follows (Trastuzumab has to be given previously for at least 12 weeks, treatment free interval of trastuzumab for a maximum of 6 weeks):
• Taxanes + trastuzumab given as adjuvant therapy
• Taxanes + trastuzumab given as first line therapy for palliation
• Trastuzumab given as first line therapy for palliation alone or in combination with chemotherapeutic agents other than capecitabine or taxanes
• No more than 1 chemotherapy for palliation (max. Adriamycin dose \< or = 400 mg/m²; Epirubicin \< or = 600 mg/m²)
• Patients must have either measurable or nonmeasurable target lesions according to the RECIST criteria (see Appendix 6)
• At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be pathologic proof of progressive disease
• At least 4 weeks since major surgery with full recovery.
• Complete radiology and tumor measurement work up within 4 weeks prior to registration:
• Karnofsky performance status evaluation \> or = 60%
• Age \>18 years.

You may not qualify if:

• Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
• Concurrent immunotherapy or hormonal therapy (antihormonal, contraceptive and/or replacement therapy). Bisphosphonates may be continued.
• Parenchymal brain metastases, unless adequately controlled by surgery and/or radiotherapy with complete resolution of symptoms and of all steroids.
• Life expectancy of less than 3 months.
• Serious intercurrent medical or psychiatric illness that may interfere with the planned treatment (including severe pulmonary conditions, AIDS and serious active infection).
• History of congestive heart failure or other significant uncontrolled cardiac disease.
• History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
• Treatment with sorivudine or derivates e.g. brivudin
• Pregnant or nursing women.
• Male patients.
• The patient must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre which could be the Principal or Co- investigator's site.

Sponsors & Collaborators

• GBG Forschungs GmbH: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Johann Wolfgang Goethe Universität, Universitätsfrauenklinik

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Links

• Click here for more information about this study: TBP Study

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gunter von Minckwitz, Prof. Dr.

  German Breast Group Forschungs GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 8, 2005
• Study Start: September 1, 2003
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 23, 2011

Record last verified: 2011-02

Locations

DE (1)