Breast CancerPhase 2NCT00841828
Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients
A Phase 2 study testing Epirubicin, Cyclophosphamide and Docetaxel in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 26 sites in Spain.
Trial summary
Phase II randomized multicenter trial to compare Epirubicin and Cyclophosphamide plus Docetaxel and Trastuzumab with Epirubicin and Cyclophosphamide plus Docetaxel and Lapatinib for patients with positive HER2 and resectable or locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Epirubicin, Cyclophosphamide and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 26 sitesSpain
- Study dates
- Feb 2009to Dec 2013
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of the written informed consent.
- Histological documentation of breast cancer.
- Stage I (T1, N0M0), IIA (T2N0M0); IIB (T2N1M0, T3N0M0), IIIA (TXN2M0) and IIIB (T3N1M0, T4NXM0) primary resectable breast cancer or locally advanced breast cancer.
- HER2-positive breast cancer, defined as immunohistochemistry (IHQ) 3+ or positive FISH. When IHQ 2+ HER2 status must be assessed by FISH.
- The patient granted her consent for taking a biopsy before treatment
- The patient granted her consent for sending two tumor samples to central laboratory for molecular sub study.
Show all 17Show fewer
- Two weeks prior randomization pregnancy test negative for women of childbearing potential.
- Women of childbearing potential must use adequate contraceptive measures during participation into study. Oral, injectable or implant hormonal contraceptives measure are not permitted.
- A World Health Organization (WHO) performance status of 0 or 1 (Karnofsky ≥ 80)
- Age > 18 years.
- Absence of metastases disease
- Baseline Electrocardiography (EKG) 12 weeks prior to randomization. Baseline left ventricular ejection fraction (LVEF) value within limit of normal value for the institution or > 50% of basal value
- Normal laboratory test 2 weeks prior to randomization:
- Haematology values: Neutrophil count ≥ 1,5 x109/l; Platelets ≥ 100 x 109/l; Haemoglobin ≥ 10mg/dl Biochemistry values: serum total bilirubin ≤ 1 x Upper Limit of Normal (ULN); Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGPT) ≤ 2,5 x ULN; alkaline phosphatase ≤ 5 x ULN. Patients which AST and/or ALT value are > 1,5 x ULN along with alkaline phosphatase value > 2,5 x ULN will be not included into the study.
- Renal function: serum creatinine ≤ 175 µmol/l (2 mg/dl). If the value is borderline, clearance creatinine must be ≥ 60 ml/min
- 12 weeks prior to randomization the following assessments and procedures must be fulfilled: Bilateral mammography; Magnetic resonance imaging (MRI) Breast and axillary; Chest X-Ray (posterioanterior and lateral); Abdominal ultrasound; Chest CT-Scan; Abdominal CT-Scan. Bone Scan (if applicable)
- Patients must be accessible for treatment and follow up
Who cannot join
- Patients with lumpectomy, partial mastectomy, modified radical mastectomy are not allowed to include into study.
- Prior Immunotherapy, hormonal therapy and chemotherapy for breast cancer is not allowed.
- Prior therapy with anthracycline and taxanes (paclitaxel and docetaxel) is not permitted for any neoplasia.
- Prior radiotherapy for breast cancer.
- Bilateral invasive breast carcinoma
- Pregnant or nursing patients. Negative pregnant test (serum or urine) 14 days prior to randomization.
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- HER 2 negative breast cancer
- Patients of childbearing potential must be use adequate contraceptive measures during study treatment. No hormonal contraceptive measure is permitted.
- Any M1 breast cancer
- Any motor or sensorial neurotoxicity grade ≥ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
- Serious cardiac illness or medical conditions: Congestive heart failure, angina pectoris requiring specific treatment, myocardial infarction 1 year prior to enroll in the study; poorly controlled hypertension or high-risk uncontrolled arrhythmias.
- History of significative neurological or psychiatric disease (psychotic, dementia or attack) what is unable to patient to grant her informed consent.
- Uncontrolled severe Infection Uncontrolled diabetes mellitus, active peptic ulcer
- Current malignancy or previous malignancy other that breast cancer. Exception cell carcinoma of the skin no melanoma, carcinoma in situ of the cervix or any other cancer in the past 10 years.
- Long term treatment with corticoids except 6 months prior to inclusion in the study and low doses (≤ 20 mg methylprednisolone or equivalent)
- Corticoid use contraindication
- Concomitant hormonal replacement therapy. Previous treatment should be interrupted before inclusion into study.
- Cardiopathy what stops patient taking Docetaxel and Trastuzumab: myocardial infarction recorded; angina pectoris requiring specific treatment; any congestive heart failure recorded; arrhythmia grade 3 or 4 according to NCI CTCAE version 3; any relevant valvular disease; chest X ray which shows cardiomegaly or EKG which shows ventricular hypertrophy unless LVEF value has been ≥ lower normal limit in the last 3 months.
- Poorly controlled hypertension (systolic > 180 mm Hg or diastolic > 100 mm Hg). The patients with controlled hypertension under treatment can be included into study
- Patients under treatment of arrhythmia, angina or congestive heart failure with drug which modifies cardiac conduction (after digital, beta blocker or inhibitors calcium channel) are excluded. However if these drugs are took for arterial tension the patient can be included into study.
- The patient must interrupt concomitant treatment with hormonal therapy ej. raloxifene, tamoxifen and selective estrogen receptor modulators (SERM) prior to randomization.
- Concomitant use of inhibitors and inductors of enzyme CYP3A4 complex (ketoconazole, itraconazole or grape juice; rifampicin, carbamazepin or fenitoin) are not permitted. Also, drug are substrate of enzyme CYP2C8 complex is not permitted along with lapatinib treatment.
- Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial within 30 days prior to randomization into study.
- Concomitant treatment with other anticancer therapy
- Hypersensitivity reaction to drugs trastuzumab, lapatinib or their excipients.
- Male
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Spain26 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Centro Oncológico de Galicia
A Coruña, 15009
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Clinic i Provincial
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital General Yagüe
Burgos, 09005
Complejo Hospitalario San Pedro de Alcántara
Cáceres, 10003
Complejo Hospitalario Universitario Reina Sofía
Córdoba, 14004
Onkologikoa
Donostia / San Sebastian, Guipuzcoa, 20012
Hospital General de Granollers
Granollers, Barcelona, 08400
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital Universitario de la Princesa
Madrid, 28006
Hospital Clínico Universitario Virgen de la Victoria
Málaga, 29010
Xarxa Asistencial de Manresa
Manresa, Barcelona, 08243
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006
Corporación Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital del Espíritu Santo
Santa Coloma de Gramenet, Barcelona, 08923
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08221
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221
Hospital Virgen de la Salud
Toledo, 45004
Hospital Universitario La Fe
Valencia, 46009
Hospital Clinico Universitario de Valencia
Valencia, 46010
Hospital Xeral Cíes
Vigo, Pontevedra, 36204
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: A Multicentre, Randomised Phase II to Compare Epirubicin (E) & Cyclophosphamide (C) Treatment Plus Docetaxel (D) & Trastuzumab vs. E & C Treatment Plus D & Lapatinib in Women With Primary Resectable or Locally Advanced HER2+ Breast Cancer
Phase II randomized multicenter trial to compare Epirubicin and Cyclophosphamide plus Docetaxel and Trastuzumab with Epirubicin and Cyclophosphamide plus Docetaxel and Lapatinib for patients with positive HER2 and resectable or locally advanced breast cancer.
Read the detailed description
This is a multicenter, open label, randomized phase II trial. Women with primary cancer and overexpression of Human Epidermal Growth Factor Receptor 2 (HER2) who have not received prior treatment for invasive breast cancer will be included. The study will analyze the efficacy and tolerance of Lapatinib and Docetaxel and the Trastuzumab and Docetaxel after 4 cycles of Epirubicin and Cyclophosphamide in patients with breast cancer HER2 positive.
102 patients will be stratified according to tumor size and estrogen receptor status (positive or negative) to be randomized to receive one of the following treatment arms:
- Experimental arm: Epirubicin 90mg/m2 in combination with cyclophosphamide 600mg/m2 intravenous (IV) every 21 days for 4 cycles, followed by oral Lapatinib 1250mg once a day plus docetaxel 100mg/m2 IV every 21 days for 4 cycles with the administration of granulocyte-colony stimulating factor (G-CSF) between days 2 and 7 or on day +1 according to the G-CSF used by the site.
- Control arm: Epirubicin 90mg/m2 in combination with cyclophosphamide 600mg/m2 IV every 21 days for 4 cycles, followed by a loading dose of Trastuzumab 8mg/kg IV followed by Trastuzumab 6mg/kg IV every 3 weeks plus docetaxel 100mg/m2 IV every 21 days for 4 cycles with the administration of G-CSF between days 2 and 7 or on day +1 according to the G-CSF used by the site.
Treatment duration: The patients will be in treatment for an average of 6 months for both arms.
Study population: Patients with operable or locally advanced breast cancer, HER2 positive who are candidates to receive neoadjuvant treatment and who have not received pre-treatment for invasive breast cancer.
Population in study and number total of patients:
The aim is to determine if neoadjuvant treatment with selective therapy can increase the complete pathological response (pCR) in breast cancer by the determination of molecular markers in the tumoral sample before treatment. Then, and between 3 and 4 weeks after the last administration of Docetaxel, and 24 hours after the administration of Lapatinib, surgery will be performed and in the surgical sample will be determined the molecular markers analyzed before of the treatment in the tumor sample.
Patients with HER2 positive, defined as immunohistochemistry 3+ or positive fluorescence in situ hybridization (FISH), will be included. If immunohistochemistry 2+ it will be necessary to confirm the HER2 positive status by FISH. All results will be reevaluated later in the central laboratory.
Statistical consideration: The sample size has been calculated using the 2-stage Simon method and with pathological complete response (pCR) as the primary study end point. Sample size has been based on the null hypothesis of a pCR of 40% and an alternative hypothesis of a pCR of 60%. Assuming an alpha error of 0.05 and a test power of 80%, 92 evaluable patients will be required to be recruited and retained in the study. Sixteen patients per arm will be included in the first stage, for at least eight pCR per arm to be seen, and 30 additional patients per arm will be included in the second stage for a total of 46 evaluable patients in each arm. Assuming a 10% drop-out rate, 102 patients will be recruited.
The objective of the random distribution to treatment arms is to select the most active arm for a subsequent development. It is based on a standard of pCR of 40%, in order to detect an increase in the pCR rate of 60% in both arms, it would be necessary to include 46 patients in each arm (Simon's method in 2 stages (Optimal design)). It has been considered an error a = 0.05 and a power 80% statistics. Therefore, in the first stage it would be necessary to include 16 patients in each arm if we found more than 7 patients with pCR in each arm we will continue including until reaching the 46 in each arm. The results will be significant if we find at least 23 patients with pCR in each arm. Assuming that 10% of patients are not evaluable, the number The total number of patients to be included is 102 patients (51 patients per arm of treatment).
- Conditions
- Breast Cancer
- Being tested
- Epirubicin, Cyclophosphamide, Docetaxel, Lapatinib, Trastuzumab
- Keywords
- HER2-positive breast cancer, Lapatinib, Neoadjuvant, Trastuzumab, Biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
Also called Ellence, Pharmorubicin
CyclophosphamideDrug
Also called Cytoxan, Neosar, Endoxan
DocetaxelDrug
Also called Taxotere
LapatinibDrug
Also called Tykerb
TrastuzumabDrug
Also called Herceptin
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Epirubicin + Cyclophosphamide -> Docetaxel + Lapatinib Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Lapatinib |
| Control | Active comparator | Epirubicin + Cyclophosphamide -> Docetaxel + Trastuzumab Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).
Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller\&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.
Measured: Up to 16 weeks
Secondary outcomes (1)
Overall Clinical Response Rate (ORR)
Overall clinical response was evaluated according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria (Therasse et al, 2000). Is defined as the sum of Complete responses plus Partial responses.
It was evaluated after the fourth EC cycle and before surgery using ultrasound, mammography, or MRI.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Hospital Clínico Universitario de ValenciaStudy Director, Study director, Hospital Clínico Universitario Virgen de la VictoriaStudy Director, Study director, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841828
- Sponsor's protocol ID
- GEICAM/2006-14
- Other IDs
- 2007-007031-13
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2009
- Last updated
- 31 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Alba E, Albanell J, de la Haba J, Barnadas A, Calvo L, Sanchez-Rovira P, Ramos M, Rojo F, Burgues O, Carrasco E, Caballero R, Porras I, Tibau A, Camara MC, Lluch A. Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial. Br J Cancer. 2014 Mar 4;110(5):1139-47. doi: 10.1038/bjc.2013.831. Epub 2014 Jan 23.
PubMed 24457911
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised Phase II to Compare Epirubicin (E) & Cyclophosphamide (C) Treatment Plus Docetaxel (D) & Trastuzumab vs. E & C Treatment Plus D & Lapatinib in Women With Primary Resectable or Locally Advanced HER2+ Breast Cancer
- ClinicalTrials.gov ID
- NCT00841828
- Acronym / sponsor ID
- GEICAM/2006-14
- Conditions
- Breast Cancer
- Keywords
- HER2-positive breast cancer, Lapatinib, Neoadjuvant, Trastuzumab, Biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2009 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II randomized multicenter trial to compare Epirubicin and Cyclophosphamide plus Docetaxel and Trastuzumab with Epirubicin and Cyclophosphamide plus Docetaxel and Lapatinib for patients with positive HER2 and resectable or locally advanced breast cancer.
Detailed description
This is a multicenter, open label, randomized phase II trial. Women with primary cancer and overexpression of Human Epidermal Growth Factor Receptor 2 (HER2) who have not received prior treatment for invasive breast cancer will be included. The study will analyze the efficacy and tolerance of Lapatinib and Docetaxel and the Trastuzumab and Docetaxel after 4 cycles of Epirubicin and Cyclophosphamide in patients with breast cancer HER2 positive.
102 patients will be stratified according to tumor size and estrogen receptor status (positive or negative) to be randomized to receive one of the following treatment arms:
- Experimental arm: Epirubicin 90mg/m2 in combination with cyclophosphamide 600mg/m2 intravenous (IV) every 21 days for 4 cycles, followed by oral Lapatinib 1250mg once a day plus docetaxel 100mg/m2 IV every 21 days for 4 cycles with the administration of granulocyte-colony stimulating factor (G-CSF) between days 2 and 7 or on day +1 according to the G-CSF used by the site.
- Control arm: Epirubicin 90mg/m2 in combination with cyclophosphamide 600mg/m2 IV every 21 days for 4 cycles, followed by a loading dose of Trastuzumab 8mg/kg IV followed by Trastuzumab 6mg/kg IV every 3 weeks plus docetaxel 100mg/m2 IV every 21 days for 4 cycles with the administration of G-CSF between days 2 and 7 or on day +1 according to the G-CSF used by the site.
Treatment duration: The patients will be in treatment for an average of 6 months for both arms.
Study population: Patients with operable or locally advanced breast cancer, HER2 positive who are candidates to receive neoadjuvant treatment and who have not received pre-treatment for invasive breast cancer.
Population in study and number total of patients:
The aim is to determine if neoadjuvant treatment with selective therapy can increase the complete pathological response (pCR) in breast cancer by the determination of molecular markers in the tumoral sample before treatment. Then, and between 3 and 4 weeks after the last administration of Docetaxel, and 24 hours after the administration of Lapatinib, surgery will be performed and in the surgical sample will be determined the molecular markers analyzed before of the treatment in the tumor sample.
Patients with HER2 positive, defined as immunohistochemistry 3+ or positive fluorescence in situ hybridization (FISH), will be included. If immunohistochemistry 2+ it will be necessary to confirm the HER2 positive status by FISH. All results will be reevaluated later in the central laboratory.
Statistical consideration: The sample size has been calculated using the 2-stage Simon method and with pathological complete response (pCR) as the primary study end point. Sample size has been based on the null hypothesis of a pCR of 40% and an alternative hypothesis of a pCR of 60%. Assuming an alpha error of 0.05 and a test power of 80%, 92 evaluable patients will be required to be recruited and retained in the study. Sixteen patients per arm will be included in the first stage, for at least eight pCR per arm to be seen, and 30 additional patients per arm will be included in the second stage for a total of 46 evaluable patients in each arm. Assuming a 10% drop-out rate, 102 patients will be recruited.
The objective of the random distribution to treatment arms is to select the most active arm for a subsequent development. It is based on a standard of pCR of 40%, in order to detect an increase in the pCR rate of 60% in both arms, it would be necessary to include 46 patients in each arm (Simon's method in 2 stages (Optimal design)). It has been considered an error a = 0.05 and a power 80% statistics. Therefore, in the first stage it would be necessary to include 16 patients in each arm if we found more than 7 patients with pCR in each arm we will continue including until reaching the 46 in each arm. The results will be significant if we find at least 23 patients with pCR in each arm. Assuming that 10% of patients are not evaluable, the number The total number of patients to be included is 102 patients (51 patients per arm of treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Docetaxel, Drug: LapatinibEpirubicin + Cyclophosphamide -> Docetaxel + Lapatinib |
| Control | Active comparator | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Docetaxel, Drug: TrastuzumabEpirubicin + Cyclophosphamide -> Docetaxel + Trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Signature of the written informed consent.
- Histological documentation of breast cancer.
- Stage I (T1, N0M0), IIA (T2N0M0); IIB (T2N1M0, T3N0M0), IIIA (TXN2M0) and IIIB (T3N1M0, T4NXM0) primary resectable breast cancer or locally advanced breast cancer.
- HER2-positive breast cancer, defined as immunohistochemistry (IHQ) 3+ or positive FISH. When IHQ 2+ HER2 status must be assessed by FISH.
- The patient granted her consent for taking a biopsy before treatment
Key exclusion criteria (26 listed)
- Patients with lumpectomy, partial mastectomy, modified radical mastectomy are not allowed to include into study.
- Prior Immunotherapy, hormonal therapy and chemotherapy for breast cancer is not allowed.
- Prior therapy with anthracycline and taxanes (paclitaxel and docetaxel) is not permitted for any neoplasia.
- Prior radiotherapy for breast cancer.
- Bilateral invasive breast carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpirubicinAlso: Ellence, Pharmorubicin | Drug | Control, Experimental |
| CyclophosphamideAlso: Cytoxan, Neosar, Endoxan | Drug | Control, Experimental |
| DocetaxelAlso: Taxotere | Drug | Control, Experimental |
| LapatinibAlso: Tykerb | Drug | Experimental |
| TrastuzumabAlso: Herceptin | Drug | Control |
Primary outcome
Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D).
Time frame: Up to 16 weeks
Within 3-4 weeks after last docetaxel dose the surgery was performed to evaluate pathological response. According to the Miller\&Payne Criteria, pCR in node-negative patients is a grade 5-A and in node-positive patients is a grade 5-D.
1 secondary outcome
Overall Clinical Response Rate (ORR)
Time frame: Up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24457911Alba E, Albanell J, de la Haba J, Barnadas A, Calvo L, Sanchez-Rovira P, Ramos M, Rojo F, Burgues O, Carrasco E, Caballero R, Porras I, Tibau A, Camara MC, Lluch A. Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial. Br J Cancer. 2014 Mar 4;110(5):1139-47. doi: 10.1038/bjc.2013.831. Epub 2014 Jan 23.
- Sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Hospital Clínico Universitario de Valencia
Study Director study director
Hospital Clínico Universitario Virgen de la Victoria
Study Director study director
Hospital del Mar
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epirubicin, Cyclophosphamide and Docetaxel in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 26 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 26 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 26 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Nov 2018). 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?
Complete Pathological Response (pCR) Rate in Breast and Axilla According to the Miller&Payne Criteria (G5-A and G5-D). (time frame: Up to 16 weeks). 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 NCT00841828, which also lists 1 linked publication.
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.