Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients

NCT00130533 | Completed Phase 3 Results

• 2 other identifiers: CIBOMA 2004-012005-002838-36
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 48

Brief 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.

Conditions

Breast Cancer

Keywords

Triple-Negative Early Breast Cancer; Maintenance Adjuvant Chemotherapy; Capecitabine; Basal-like genotype; Triple-Negative

Outcome Measures

Primary Outcomes (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.

  5 years

Secondary Outcomes (3)

• Disease Free Survival (DFS) Events by Phenotype

  5 years

• Overall Survival (OS) Event

  5 years

• The Number of Participants Who Experienced Adverse Events (AE)

  5 years

Study Arms (2)

Xeloda (capecitabine)

EXPERIMENTAL

1000 mgrs/m2 twice a day, tablets, 8 cycles

Drug: Capecitabine

Observation

NO INTERVENTION

Observation. No intervention.

Interventions

Capecitabine DRUG

Also known as: Xeloda

Xeloda (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 (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.
• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Hoffmann-La Roche: collaborator
• IBEROAMERICAN COALITION FOR BREAST ONCOLOGY RESEARCH (CIBOMA): collaborator

Study Sites (48)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Instituto Catalán de Oncología de L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital del Espíritu Santo

Santa Coloma de Gramenet, Barcelona, 08923, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Provincial de Castellón

Castellon, Castellón, 12002, Spain

Location

Hospital General de Jerez

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Onkologikoa

Donostia / San Sebastian, Guipúzcoa, 20012, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, Guipúzcoa, 20014, Spain

Location

Hospital de Barbastro

Barbastro, Huesca, 22300, Spain

Location

Hospital Insular de Las Palmas de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA)

San Sebastián de los Reyes, Madrid, 28703, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, 36312, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Centro Oncológico de Galicia

A Coruña, 15009, Spain

Location

Hospital Universitario General de Alicante

Alicante, 03010, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital Universitario Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital Universitario General Yagüe

Burgos, 09006, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital General Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28021, Spain

Location

Hospital Ruber Internacional

Madrid, 28034, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital de Madrid Norte Sanchinarro (CIOCC)

Madrid, 28050, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Madrid, 30120, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Complejo Hospitalario de Ourense

Ourense, 32005, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario de Valme

Seville, 41014, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Provincial de Zamora "Rodríguez Chamorro"

Zamora, 49021, Spain

Location

Hospital Clínico Universitario de Zaragoza "Lozano Blesa"

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (4)

• 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.

  PMID: 31804894 RESULT

• 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.

  PMID: 33397968 RESULT

• 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.

  PMID: 36346687 RESULT

• 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.

  PMID: 35279130 RESULT

Related Links

• Sponsor's web
• Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

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

Results Point of Contact

• Title: Scientific Director / Medical Lead / Project Manager
• Organization: Spanish Breast Cancer Research Group

geicam@geicam.org

+34916592870

Study Officials

• Study Principal Investigator

  Hospital Clínico Universitario de Valencia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: January 1, 2006
• Primary Completion: February 17, 2017
• Study Completion: February 17, 2017
• Last Updated: March 31, 2023
• Results First Posted: October 25, 2019

Record last verified: 2023-03

Locations

ES (48)