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Breast CancerPhase 3NCT00129935

EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer

A Phase 3 study testing Docetaxel, Capecitabine and Epirubicin in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 58 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, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2) negative, node positive breast cancer patients. 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?
Docetaxel, Capecitabine and Epirubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,384 participants
Where
58 sitesSpain
Study dates
Feb 2004to 4 Apr 2019
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 diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days.
  • Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinomas in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
  • Positive axillary lymph nodes defined as at least 1 out of 10 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: TNM pathologic stage N1a, TNM pathologic stage N2a, TNM pathologic stage N3a.
  • Status of hormone receptors in primary tumour. Results must be available before the end of adjuvant chemotherapy.
  • Patients must not present evidence of metastatic disease. Status of HER2 in primary tumour, known before randomization. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescence in situ hybridization (FISH) is mandatory and result must be negative.
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  • Age >= 18 and <= 70 years old.
  • Performance status (Karnofsky index) >= 80.
  • Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).
  • Laboratory results (within 14 days prior to randomization):
  • Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100 x 10^9/l; hemoglobin >= 10 mg/dl;
  • Hepatic function: total bilirubin <= 1 upper normal limit (UNL); serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (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 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min;
  • Pharmacogenetics: one blood sample is needed for single nucleotide polymorphism (SNP) assessment.
  • Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests: as clinically indicated.
  • Patients able to comply with treatment and study follow-up.
  • Negative pregnancy test done in the 14 prior days to randomization.

Who cannot join

  • Prior systemic therapy for breast cancer.
  • Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
  • Prior radiotherapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.
  • Any T4 or M1 tumour.
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  • Axillary lymph nodes: patients belonging to the following classifications are excluded: TNM pathologic stage N1b, TNM pathologic stage N1c, TNM pathologic stage N2b, TNM pathologic stage N3b, TNM pathologic stage N3c.
  • HER2 positive breast cancer (IHC 3+ or positive FISH result).
  • Pre-existing grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 [NCICTC v-2.0]).
  • 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 from free informed consent.
  • Active uncontrolled infection.
  • Active peptic ulcer; unstable diabetes mellitus.
  • Previous or current history of neoplasms different from 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.
  • Chronic treatment with corticosteroids.
  • Contraindications for corticosteroid administration.
  • Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.
  • Concomitant treatment with other investigational products; participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.
  • Concomitant treatment with another therapy for cancer.
  • Males.

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

Spain58 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Centro Oncológico de Galicia

    A Coruña, 15009

  • Hospital General Universitario de Albacete

    Albacete, 02066

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario Virgen de los Lirios

    Alicante, 03804

  • Hospital Municipal de Badalona

    Badalona, Barcelona, 08911

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital de Barbastro

    Barbastro, Huesca, 22300

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital Provincial de Castellón

    Castellon, Castellón, 12002

  • Hospital Universitario Reina Sofía

    Córdoba, Cordoba, 14004

  • Onkologikoa

    Donostia / San Sebastian, Guipúzcoa, 20012

  • Hosptial Donostia

    Donostia / San Sebastian, Guipúzcoa, 20014

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital General Universitario de Elda

    Elda, Alicante, 03600

  • Hospital Arquitecto Marcide

    Ferrol, A Coruña, 15405

  • Instituto Catalán de Oncología de Girona

    Girona, 17007

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital General Universitario de Guadalajara

    Guadalajara, 19002

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid, 28911

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario 12 de Octubre

    Madrid, 28021

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Complejo Hospitalario Unviersitario de Ourense

    Ourense, 32005

  • Hospital Universitario San Joan de Reus

    Reus, Tarragona, 43201

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital del Espíritu Santo

    Santa Coloma de Gramenet, Barcelona, 08923

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario de Valme

    Seville, 41014

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

  • Hospital Universitario La Fe

    Valencia, 46009

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospial General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitario Arnau de Vilanova de Valencia

    Valencia, 46015

  • Hospital General Universitario de Vic

    Vic, Barcelona, 08500

  • Hospital Provincial Rodríguez Chamorro de Zamora

    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: Phase III Trial to Compare Epirubicin and Cyclophosphamide (EC) Followed by Docetaxel (T) to Epirubicin and Docetaxel (ET) Followed by Capecitabine (X) as Adjuvant Treatment, Node Positive Breast Cancer Patients

This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2) negative, node positive breast cancer patients.

Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4 cycles of T 100 mg/m2 day 1 every 3 weeks.

Read more

Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by 4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period.

Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy.

Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors (or both) after the end of chemotherapy.

Patients may receive radiotherapy when clinically indicated.

Read the detailed description

Estimation of the 5-year disease-free survival in the control arm is 72%. The experimental arm is expected to increase the 5-year disease-free survival by 7% (up to 79%). With an alpha error of 0.05 and 80% power, 592 patients per arm are needed. Assuming a 17% post-randomization drop-out, 691 patients per arm are needed.

Conditions
Breast Cancer
Keywords
HER2 negative breast cancer, Node positive breast cancer, Adjuvant treatment, Oral chemotherapy
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 NCT00129935
Study groupRoleWhat they receive
Arm A: EC-TActive comparatorEpirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Receives: Drug: Docetaxel; Drug: Epirubicin; Drug: Cyclophosphamide
Arm B: ET-XExperimentalEpirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Receives: Drug: Docetaxel; Drug: Capecitabine; Drug: Epirubicin

What is being measured

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

  1. Number of Participants With Disease-free Survival (DFS) Event

    A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.

    Measured: 5 years

Secondary outcomes (5)

  1. Number of Participants With Overall Survival (OS) Event

    A participant was considered to have had a OS event if patient died from any cause.

    Measured: Up to 5 years

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

    Safety was assessed by standard clinical and laboratory tests, and were evaluated using NCI-CTC criteria v2.0

    Measured: 5 years

  3. Quality of Life Questionnaire: Number of Participants With Hair Loss

    Hair loss was assessed by the quality of life of the patients through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 23 (EORTC QLQ-BR23) profile questionnaire, question 4. The quality of life of the patients was evaluated before each cycle and at the end of treatment.

    In questionnaire, raw scores range from 0 to 100 and a high score represents a high level of functioning or Health Related Quality of Life, excluding single-item scales in which high scores represent a high level of symptoms. A difference of 10 points on the scale over baseline value was classified as the minimum clinically meaningful change in both questionnaires.

    Measured: Up to 24 months

  4. Quality of Life Questionnaire: Number of Participants With Hair Loss Recovery

    Hair Loss Recovery was assessed by a specific Hair Toxicity Questionnaire were patients answered if the hair was less abundant than before, weaker than before or other.

    The questionnaire was evaluated up to two years after the end of chemotherapy.

    Measured: Up to 30 months

  5. Quality of Life Questionnaire: Time to Taking Off the Wig

    Time to taking off the wig was assessed by a specific Hair Toxicity Questionnaire were patients answered when they stop to use the wig.

    The questionnaire was evaluated up to two years after the end of chemotherapy.

    Measured: Up to 30 months

Timeline

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

  1. First posted12 Aug 2005 (estimated)
  2. Study startFeb 2004
  3. Primary completionJun 2013
  4. Study completion4 Apr 2019

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
1,384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129935
Sponsor's protocol ID
GEICAM 2003-10
Status last verified
Mar 2023
First submitted
11 Aug 2005
Last updated
31 Mar 2023
Data monitoring committee
No

Publications

  • Martin M, Ruiz Simon A, Ruiz Borrego M, Ribelles N, Rodriguez-Lescure A, Munoz-Mateu M, Gonzalez S, Margeli Vila M, Barnadas A, Ramos M, Del Barco Berron S, Jara C, Calvo L, Martinez-Janez N, Mendiola Fernandez C, Rodriguez CA, Martinez de Duenas E, Andres R, Plazaola A, de la Haba-Rodriguez J, Lopez-Vega JM, Adrover E, Ballesteros AI, Santaballa A, Sanchez-Rovira P, Baena-Canada JM, Casas M, del Carmen Camara M, Carrasco EM, Lluch A. Epirubicin Plus Cyclophosphamide Followed by Docetaxel Versus Epirubicin Plus Docetaxel Followed by Capecitabine As Adjuvant Therapy for Node-Positive Early Breast Cancer: Results From the GEICAM/2003-10 Study. J Clin Oncol. 2015 Nov 10;33(32):3788-95. doi: 10.1200/JCO.2015.61.9510. Epub 2015 Sep 28.

    PubMed 26416999

  • van Mackelenbergh MT, Seither F, Mobus V, O'Shaughnessy J, Martin M, Joensuu H, Untch M, Nitz U, Steger GG, Miralles JJ, Barrios CH, Toi M, Bear HD, Muss H, Reimer T, Nekljudova V, Loibl S. Effects of capecitabine as part of neo-/adjuvant chemotherapy - A meta-analysis of individual breast cancer patient data from 13 randomised trials including 15,993 patients. Eur J Cancer. 2022 May;166:185-201. doi: 10.1016/j.ejca.2022.02.003. Epub 2022 Mar 16.

    PubMed 35305453

  • Garcia-Saenz JA, Spera G, Pollan M, Bermejo B, Ruiz-Borrego M, Chan A, Martin M, Guerrero-Zotano A, Calvo L, Rodriguez-Lescure A, Marin M, Chap L, Crown J, Pienkowski T, Bee V, Casas M, Polonio O, Bezares S, Slamon D. Body mass index as a predictive factor for efficacy of adjuvant taxane-based chemotherapy in early-stage breast cancer patients: A pooled analysis from adjuvant GEICAM Spanish Breast Cancer Group and TRIO Translational Research in Oncology Group studies. Int J Cancer. 2025 Aug 15;157(4):709-721. doi: 10.1002/ijc.35432. Epub 2025 Apr 10.

    PubMed 40207789

  • Martin M, Carrasco E, Rodriguez-Lescure A, Andres R, Servitja S, Anton A, Ruiz-Borrego M, Bermejo B, Guerrero A, Ramos M, Santaballa A, Munoz M, Cruz J, Lopez-Tarruella S, Chacon JI, Alvarez I, Martinez P, Miralles JJ, Polonio O, Jara C, Aguiar-Bujanda D. Long-term outcomes of high-risk HR-positive and HER2-negative early breast cancer patients from GEICAM adjuvant studies and El Alamo IV registry. Breast Cancer Res Treat. 2023 Sep;201(2):151-159. doi: 10.1007/s10549-023-07002-1. Epub 2023 Jun 20.

    PubMed 37338729

  • Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

    PubMed 34037241

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Capecitabine and Epirubicin in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 58 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 17 inclusion and 20 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 58 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?

Number of Participants With Disease-free Survival (DFS) Event (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 NCT00129935, which also lists 5 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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