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Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 15, 2005
Last Update Posted: September 11, 2017
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.
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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 Intervention Phase
Breast Cancer Drug: Capecitabine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • Disease free survival

Secondary Outcome Measures:
  • Overall survival
  • Toxicity profile
    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).

  • Chemotherapy-related amenorrhea
  • Single nucleotide polymorphisms (SNPs) predicting response to capecitabine
  • 5-year disease free survival

Enrollment: 876
Study Start Date: January 2006
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xeloda (capecitabine) Drug: Capecitabine
1000 mgrs/m2 twice a day, tablets, 8 cycles
No Intervention: Observation


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00130533

Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA)
San Sebastián de los Reyes, Madrid, Spain, 28703
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Hoffmann-La Roche
  More Information

Additional Information:
Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00130533     History of Changes
Other Study ID Numbers: CIBOMA 2004-01
First Submitted: August 12, 2005
First Posted: August 15, 2005
Last Update Posted: September 11, 2017
Last Verified: September 2017

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