Capecitabine Plus Radiotherapy for Local Relapse Breast Cancer With Negative Her2 Tumours

NCT00434941 | Terminated Phase 2

• 1 other identifier: GEICAM/2005-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 7

Brief Summary

This is a prospective, open-label, multicenter phase IV.II study. Patients with local relapse breast cancer will receive radiotherapy concomitant to the administration of capecitabine.

Conditions

Breast Cancer

Keywords

Administration of capecitabine concomitant to radiotherapy; Her2: negative

Outcome Measures

Primary Outcomes (1)

• Complete clinical response rate

  The disease evaluation will be measured by RECIST criteria in the 28 days after the end of the radiotherapy by Magnetic resonance imaging (MRI).

  28 days after the end of the radiotherapy

Secondary Outcomes (1)

• Evaluation of the concomitant administration of capecitabine and radiotherapy as the first treatment

  28 days after the end of the radiotherapy

Study Arms (1)

Radiotherapy + Capecitabine

EXPERIMENTAL

Radiotherapy (for 25 days; Dose: 50 Gy) + Capecitabine (for 35 days; Dose: 825 mg/m2 twice per day p.o.) Experimental treatment consists of administration of 825 mg/m2 x 2 daily p.o., for 7 days simultaneously with daily radiotherapy treatment.Capecitabine will be administered for 35 days as maximum.

Drug: Capecitabine; Radiation: Radiotherapy

Interventions

Capecitabine DRUG

Also known as: Xeloda

Radiotherapy + Capecitabine

Radiotherapy RADIATION

Radiotherapy + Capecitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Histological diagnoses of operable invasive adenocarcinoma of the breast.
• Patients with tumour HER2 negative.
• Previous mastectomy surgery.
• Actual diagnoses of local recurrence of breast cancer.
• Patients must not present evidence of metastatic disease.
• Age \>= 18 years old.
• Performance status (Karnofsky index) \>= 70.
• Laboratory results (within 14 days prior to randomization):
• Hematology:
• neutrophils \>= 1.5 x 10e9/l;
• platelets \>= 100x 10e9/l;
• hemoglobin \>= 10 mg/dl
• Hepatic function:
• total bilirubin \<= 1,5 upper normal limit (UNL);

You may not qualify if:

• Distant metastasis or metastatic disease in organs.
• Metastasis in internal mammary chain lymph nodes
• Previous radiation treatment on the breast or other locations (30% or greater of the bone marrow).
• Prior treatment with continuous (greater than 24h) 5-fluorouracil (5-FU) infusion, capecitabine or other oral fluoropyrimidines such as eniluracil/5-FU , uracil/tegafur, S1 or emitefur.
• Known hypersensitivity to capecitabine, doxifluridine or any of its components.
• Organ allografts that require an immunosuppressor therapy.
• History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.
• Clinically significant cardiac disease such as congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication or history of myocardial infarction within the last 12 months or uncontrolled hypertension.
• Evidence of central nervous system (CNS) metastases. Pts with a history of uncontrolled seizures, CNS disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance should be excluded from the study.
• Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.
• Active uncontrolled infection or other severe pathologies such as active peptic ulcer, unstable diabetes mellitus.
• Major surgery during 4 weeks prior to treatment.
• Patients lacking physical integrity of upper gastrointestinal tract or with history of bad absorption syndrome.
• Anticoagulant treatment with coumadin anticoagulants.
• Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Hoffmann-La Roche: collaborator

Study Sites (7)

Hospital Infanta Cristina

Badajoz, 06080, Spain

Location

Hospital de la Esperanza

Barcelona, 08024, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario La Fe

Valencia, 46010, Spain

Location

Related Links

• Sponsor's website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Radiotherapy

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; Therapeutics

Study Officials

• Study Director

  Hospital Clínico Universitario San Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 14, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

ES (7)