Trial record 1 of 1 for:    CIBOMA/2004-01
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Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients

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: NCT00130533
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : February 16, 2018
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief Summary:

This is a prospective, open-label, randomized phase III study. Patients will be stratified as per investigational site, previous adjuvant chemotherapy (anthracyclines versus anthracyclines plus taxanes), and number of affected axillary lymph nodes (0, 1-3, >= 4). Node negative patients must present a tumour size > 2 cm to be eligible. At least 6 lymph nodes must be analysed to confirm the number of affected nodes. Patients will be randomised to receive: 8 courses of capecitabine 1000 mg/m2 by mouth, twice a day (p.o. bid) for 14 days, followed by a 7 day rest versus observation.

Tissue samples must be analysed by a central laboratory, to confirm estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor-2 (HER2), cytokeratins CK 5/6 and epidermal growth factor receptor (EGFR) status.

The following data were obtained from the database of the "El Alamo" project. One thousand six hundred and twenty-seven (1,627) in total were considered during the years 1990 to 1997. The population is formed of patients with operable breast cancer, with surgery, positive nodes, and negative hormone receptors, or negative nodes, negative hormone receptors and T2-3 tumors.

For these patient groups, estimated 5-year disease-free survival is 64.72%. Assuming an exponential distribution, the aim is to detect an increase of 64.72% to 73.7% in 5 years Disease Free survival rate corresponds to a Hazard Ratio of 0.701 and a risk reduction of about 30%, with a power of 80% using a two-tailed log-rank test at 0.05 and whereas 4 years of recruitment period and 3 years of follow-up period. We would need 255 events, 834 patients without considering any dropouts.

Considering a drop-out rate of 5% post-randomization, the final sample size will be 876 patients, 438 per treatment arm.

The sample size calculation was performed by the program package EAST version 5.2.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 876 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Open-label, Randomized Phase III Trial, to Evaluate Efficacy of Maintenance Treatment With Capecitabine (X) Following Standard Adjuvant Chemotherapy, in Operable Breast Cancer Patients With Negative Hormone Receptor, Negative HER2 Tumours
Actual Study Start Date : January 2006
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Xeloda (capecitabine)
1000 mgrs/m2 twice a day, tablets, 8 cycles
Drug: Capecitabine
1000 mgrs/m2 twice a day, tablets, 8 cycles

No Intervention: Observation
Observation. No intervention.

Primary Outcome Measures :
  1. Disease free survival [ Time Frame: At the end of Cycle 8 (each cycle is 28 days) ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
  2. Toxicity profile [ Time Frame: 5 years ]
    Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AEs grade will be defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

  3. Chemotherapy-related amenorrhea [ Time Frame: 5 years ]
  4. Single nucleotide polymorphisms (SNPs) predicting response to capecitabine [ Time Frame: 5 years ]
  5. Disease free survival [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent.
  • Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between end of adjuvant chemotherapy and study randomization must be less than 8 weeks. In patients receiving adjuvant radiotherapy, time window allowed between last session and randomisation is 4 weeks.
  • Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinoma in-situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
  • Node negative patients with tumour size > 2 cm.
  • Positive axillary lymph nodes defined as at least 1 out of 6 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: pN1a, pN2a, pN3a.
  • Status of hormone receptors in primary tumour. Negative results must be available before the end of adjuvant chemotherapy.
  • Patients must not present evidence of metastatic disease.
  • Negative status of HER2 in primary tumour, known before randomization.
  • Adjuvant chemotherapy consisting of a minimum of 6 courses with anthracyclines and/or taxanes.
  • Age >= 18 and <= 70 years old.
  • Performance status (Karnofsky index) >= 80.
  • 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 UNL;
    • SGOT and SGPT <= 2.5 UNL;
    • alkaline phosphatase <= 2.5 UNL.
    • If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible.
  • Renal Function:

    • creatinine <= 175 µmol/l (2 mg/dl).
    • creatinine clearance >= 60 ml/min.
  • Pharmacogenetics:

    • one blood sample is needed for SNPs assessment.
  • Patients able to comply with treatment and study follow-up.
  • Negative pregnancy test done in the 14 previous days to randomization.

Exclusion Criteria:

  • Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
  • 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.
  • Bilateral invasive breast cancer.
  • Any T4 or M1 tumour.
  • Axillary lymph nodes: patients belonging to the following classifications are excluded: pN1b, pN1c, pN2b, pN3b, pN3c.
  • Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled HA or high risk arrhythmias.
  • History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.
  • Active uncontrolled infection.
  • Active peptic ulcer, unstable diabetes mellitus.
  • Previous or current history of neoplasms different to breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
  • History of hypersensitivity to capecitabine, fluorouracil.
  • Patients lacking physical integrity of upper gastrointestinal tract or with history of bad absorption syndrome.
  • History of dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Anticoagulant treatment with coumadin anticoagulants.
  • Current treatment with sorivudine or its chemical family.
  • 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.
  • Males.

Information from the National Library of Medicine

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): NCT00130533

Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Instituto Catalán de Oncología de L'Hospitalet
L'Hospitalet De Llobregat, Barcelona, Spain, 08908
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital del Espíritu Santo
Santa Coloma De Gramenet, Barcelona, Spain, 08923
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Provincial de Castellón
Castellón De La Plana, Castellón, Spain, 12002
Hospital General de Jerez
Jerez De La Frontera, Cádiz, Spain, 11407
Donostia-San Sebastián, Guipúzcoa, Spain, 20012
Hospital de Donostia
Donostia-San Sebastián, Guipúzcoa, Spain, 20014
Hospital de Barbastro
Barbastro, Huesca, Spain, 22300
Hospital Insular de Las Palmas de Gran Canaria
Las Palmas De Gran Canaria, Las Palmas, Spain, 35016
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA)
San Sebastián de los Reyes, Madrid, Spain, 28703
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain, 36312
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Centro Oncológico de Galicia
A Coruña, Spain, 15009
Hospital Universitario General de Alicante
Alicante, Spain, 03010
Hospital del Mar
Barcelona, Spain, 08003
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital Universitario Germans Trias i Pujol
Barcelona, Spain, 08916
Hospital Universitario General Yagüe
Burgos, Spain, 09006
Hospital Universitario Puerta del Mar
Cádiz, Spain, 11009
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Hospital General Universitario de Guadalajara
Guadalajara, Spain, 19002
Complejo Hospitalario de Jaén
Jaén, Spain, 23007
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Spain, 25198
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Universitario 12 de Octubre
Madrid, Spain, 28021
Hospital Ruber Internacional
Madrid, Spain, 28034
Hospital Clínico Universitario San Carlos
Madrid, Spain, 28040
Hospital de Madrid Norte Sanchinarro (CIOCC)
Madrid, Spain, 28050
Hospital Universitario Virgen de la Arrixaca
Madrid, Spain, 30120
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Hospital Regional Universitario Carlos Haya
Málaga, Spain, 29010
Complejo Hospitalario de Ourense
Ourense, Spain, 32005
Hospital Clínico Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz De Tenerife, Spain, 38010
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Hospital Universitario de Valme
Sevilla, Spain, 41014
Hospital Virgen de la Salud
Toledo, Spain, 45004
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Provincial de Zamora "Rodríguez Chamorro"
Zamora, Spain, 49021
Hospital Clínico Universitario de Zaragoza "Lozano Blesa"
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Hoffmann-La Roche
Study Director: Study Director Hospital Clínico Universitario de Valencia

Additional Information:
Responsible Party: Spanish Breast Cancer Research Group Identifier: NCT00130533     History of Changes
Other Study ID Numbers: CIBOMA 2004-01
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Keywords provided by Spanish Breast Cancer Research Group:
TNBC Triple-Negative Early Breast Cancer
Maintenance Adjuvant Chemotherapy
Basal-like genotype

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents