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Breast CancerPhase 3NCT00130533

Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients

A Phase 3 study testing Capecitabine in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 48 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a prospective, open-label, randomized phase III study assessing adjuvant capecitabine after standard chemotherapy for patients with early triple negative breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
876 participants
Where
48 sitesSpain
Study dates
Jan 2006to 17 Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 (Metastases in 1-3 axillary lymph nodes, at least one metastasis greater than 2.0 mm), pN2a (Metastases in 4-9 axillary lymph nodes (at least one tumor deposit greater than 2 mm)), pN3a (Metastases in 10 or more axillary lymph nodes [at least one tumor deposit greater than 2 mm]; or metastases to the infraclavicular [level III axillary lymph] nodes).
  • Status of hormone receptors in primary tumour. Negative results must be available before the end of adjuvant chemotherapy.
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  • 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 upper normal limit (UNL);
  • Aspartate aminotransferase (AST or SGOT) and Alanine aminotransferase (ALT or 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 single nucleotide polymorphism (SNP) assessment.
  • Patients able to comply with treatment and study follow-up.
  • Negative pregnancy test done in the 14 previous days to randomization.

Who cannot join

  • 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 (Metastases in internal mammary nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN1c (Metastases in 1-3 axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN2b (Metastases in clinically detected internal mammary lymph nodes in the absence of axillary lymph node metastases), pN3b (Metastases in clinically detected ipsilateral internal mammary lymph nodes in the presence of one or more positive axillary lymph nodes; or in more than three axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN3c (Metastases in ipsilateral supraclavicular lymph nodes).
  • Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.
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  • 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.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

Spain48 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Centro Oncológico de Galicia

    A Coruña, 15009

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital Universitario General de Alicante

    Alicante, 03010

  • Hospital de Barbastro

    Barbastro, Huesca, 22300

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Universitario General Yagüe

    Burgos, 09006

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital Provincial de Castellón

    Castellon, Castellón, 12002

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Onkologikoa

    Donostia / San Sebastian, Guipúzcoa, 20012

  • Hospital de Donostia

    Donostia / San Sebastian, Guipúzcoa, 20014

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital General Universitario de Guadalajara

    Guadalajara, 19002

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital General de Jerez

    Jerez de la Frontera, Cádiz, 11407

  • Instituto Catalán de Oncología de L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Insular de Las Palmas de Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Universitario 12 de Octubre

    Madrid, 28021

  • Hospital Ruber Internacional

    Madrid, 28034

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Hospital de Madrid Norte Sanchinarro (CIOCC)

    Madrid, 28050

  • Hospital Universitario Virgen de la Arrixaca

    Madrid, 30120

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Complejo Hospitalario de Ourense

    Ourense, 32005

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA)

    San Sebastián de los Reyes, Madrid, 28703

  • Hospital del Espíritu Santo

    Santa Coloma de Gramenet, Barcelona, 08923

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario de Valme

    Seville, 41014

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

  • Hospital Virgen de la Salud

    Toledo, 45004

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36312

  • Hospital Provincial de Zamora "Rodríguez Chamorro"

    Zamora, 49021

  • Hospital Clínico Universitario de Zaragoza "Lozano Blesa"

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients

This is a prospective, open-label, randomized phase III study assessing adjuvant capecitabine after standard chemotherapy for patients with early triple negative breast cancer.

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
Capecitabine
Keywords
Triple-Negative Early Breast Cancer, Maintenance Adjuvant Chemotherapy, Capecitabine, Basal-like genotype, Triple-Negative
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00130533
Study groupRoleWhat they receive
Xeloda (capecitabine)Experimental1000 mgrs/m2 twice a day, tablets, 8 cycles
Receives: Drug: Capecitabine
ObservationNo interventionObservation. No intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival (DFS) Events

    DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.

    Measured: 5 years

Secondary outcomes (3)

  1. Disease Free Survival (DFS) Events by Phenotype

    DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.

    Measured: 5 years

  2. Overall Survival (OS) Event

    OS event is defined as the death from any cause.

    Measured: 5 years

  3. The Number of Participants Who Experienced Adverse Events (AE)

    Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2005 (estimated)
  2. Study startJan 2006
  3. Primary completion17 Feb 2017
  4. Study completion17 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
876 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00130533
Sponsor's protocol ID
CIBOMA 2004-01
Other IDs
2005-002838-36, 2005
Status last verified
Mar 2023
First submitted
12 Aug 2005
Last updated
31 Mar 2023

Publications

  • Lluch A, Barrios CH, Torrecillas L, Ruiz-Borrego M, Bines J, Segalla J, Guerrero-Zotano A, Garcia-Saenz JA, Torres R, de la Haba J, Garcia-Martinez E, Gomez HL, Llombart A, Bofill JS, Baena-Canada JM, Barnadas A, Calvo L, Perez-Michel L, Ramos M, Fernandez I, Rodriguez-Lescure A, Cardenas J, Vinholes J, Martinez de Duenas E, Godes MJ, Segui MA, Anton A, Lopez-Alvarez P, Moncayo J, Amorim G, Villar E, Reyes S, Sampaio C, Cardemil B, Escudero MJ, Bezares S, Carrasco E, Martin M; GEICAM Spanish Breast Cancer Group; CIBOMA (Iberoamerican Coalition for Research in Breast Oncology); LACOG (Latin American Cooperative Oncology Group). Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01). J Clin Oncol. 2020 Jan 20;38(3):203-213. doi: 10.1200/JCO.19.00904. Epub 2019 Dec 5.

    PubMed 31804894

  • Schettini F, Chic N, Braso-Maristany F, Pare L, Pascual T, Conte B, Martinez-Saez O, Adamo B, Vidal M, Barnadas E, Fernandez-Martinez A, Gonzalez-Farre B, Sanfeliu E, Cejalvo JM, Perrone G, Sabarese G, Zalfa F, Peg V, Fasani R, Villagrasa P, Gavila J, Barrios CH, Lluch A, Martin M, Locci M, De Placido S, Prat A. Clinical, pathological, and PAM50 gene expression features of HER2-low breast cancer. NPJ Breast Cancer. 2021 Jan 4;7(1):1. doi: 10.1038/s41523-020-00208-2.

    PubMed 33397968

  • Asleh K, Lluch A, Goytain A, Barrios C, Wang XQ, Torrecillas L, Gao D, Ruiz-Borrego M, Leung S, Bines J, Guerrero-Zotano A, Garcia-Saenz JA, Cejalvo JM, Herranz J, Torres R, Haba-Rodriguez J, Ayala F, Gomez H, Rojo F, Nielsen TO, Martin M. Triple-Negative PAM50 Non-Basal Breast Cancer Subtype Predicts Benefit from Extended Adjuvant Capecitabine. Clin Cancer Res. 2023 Jan 17;29(2):389-400. doi: 10.1158/1078-0432.CCR-22-2191.

    PubMed 36346687

  • Ye F, Bian L, Wen J, Yu P, Li N, Xie X, Wang X. Additional capecitabine use in early-stage triple negative breast cancer patients receiving standard chemotherapy: a new era? A meta-analysis of randomized controlled trials. BMC Cancer. 2022 Mar 12;22(1):261. doi: 10.1186/s12885-022-09326-5.

    PubMed 35279130

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 48 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) Events (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00130533, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.

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