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Multicenter Phase IV.II Trial, for the Administration of Capecitabine Simultaneous to Radiotherapy for Local Relapse Breast Cancer Patients With Negative Her2 Tumours


Phase 2
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

Multicenter Phase IV.II Trial, for the Administration of Capecitabine Simultaneous to Radiotherapy for Local Relapse Breast Cancer Patients With Negative Her2 Tumours


Inclusion Criteria:



- 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 UNL;

- SGOT and SGPT <= 1.5 UNL;

- alkaline phosphatase <= 1.5 UNL.

- Renal Function:

- creatinine <= 175 ┬Ámol/l (2 mg/dl)or creatinine clearance >= 60 ml/min.

Exclusion Criteria:

- 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-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 requiere an inmmunosupressor 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
hipertension.

- Evidence of 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 patohologies 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.

- Concomitant treatment with other therapy for cancer.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete clinical response rate assessed by RMI and RECIST criteria

Outcome Time Frame:

4 weeks after completion of quemotherapy

Safety Issue:

Yes

Principal Investigator

Manuel De las Heras

Investigator Role:

Study Chair

Investigator Affiliation:

Spanish Research Breast Cancer Group

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEICAM/2005-01

NCT ID:

NCT00434941

Start Date:

September 2007

Completion Date:

January 2009

Related Keywords:

  • Breast Cancer
  • Administration of capecitabine concomitant to radiotherapy
  • Her2: negative
  • Breast Neoplasms

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