This trial is active, not recruiting.

Condition breast cancer
Treatment epirubicin, cyclophosphamide, taxotere, herceptín, lapatinib
Phase phase 2/phase 3
Sponsor Spanish Breast Cancer Research Group
Collaborator GlaxoSmithKline
Start date February 2009
End date December 2011
Trial size 102 participants
Trial identifier NCT00841828, GEICAM/2006-14, Nº EudraCT 2007-007031-13


Phase II randomized multicenter Trial to compare Epirubicine and Cyclophosphamide plus Docetaxel and Trastuzumab with Epirubicine and Cyclophosphamide plus Docetaxel and Lapatinib for patients with positive HER2 neu and resectable breast cancer or locally advanced breast cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
EC -> T + Lapatinib Drugs plus Biological
epirubicin, cyclophosphamide, taxotere, herceptín, lapatinib
- EC (each 21 days for 4 cycles) -> T + lapatinib (each 21 days for 4 cycles) vs EC (each 21 days for 4 cycles) -> T + herceptin (each 21 days for 4 cycles)
(Active Comparator)
EC -> T + Trastuzumab Drug plus Biological
epirubicin, cyclophosphamide, taxotere, herceptín, lapatinib
- EC (each 21 days for 4 cycles) -> T + lapatinib (each 21 days for 4 cycles) vs EC (each 21 days for 4 cycles) -> T + herceptin (each 21 days for 4 cycles)

Primary Outcomes

Complete pathological response Rate
time frame: Within 3-4 weeks after last docetaxel dose, surgery will be performed to evaluate pathological response

Secondary Outcomes

Toxicity assessment
time frame: After each treatment cycle

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Signature of the written informed consent. 2. Histological documentation of breast cancer. 3. Stage I (T1, N0M0), IIA (T2N0M0); IIB (T2N1M0, T3N0M0), IIIA (TXN2M0) and IIIB (T3N1M0, T4NXM0) primary resectable breast cancer or locally advanced breast cancer. 4. HER2-positive breast cancer, defined as IHC 3+ or positive FISH. When IHC 2+ HER2 status must be assessed by FISH. 5. The patient granted her consent for taking a biopsy before treatment 6. The patient granted her consent for sending two tumor samples to central laboratory for molecular sub study. 7. Two weeks prior randomization pregnancy test negative for women of childbearing potential. 8. Women of childbearing potential must use adequate contraceptive measures during participation into study. Oral, injectable or implant hormonal contraceptives measure are not permitted. 9. A WHO performance status of 0 or 1 ( Karnofsky ³ 80) 10. Age > 18 years. 11. Absence of metastases disease 12. Baseline EKG 12 weeks prior to randomization. Baseline LVEF value within limit of normal value for the institution or > 50% of basal value 13. Normal laboratory test 2 weeks prior to randomization Haematology values: Neutrophil count ≥ 1,5 x109/l; Platelets ≥ 100 x 109/l; Haemoglobine ≥ 10mg/dl Biochemistry values: serum total bilirubin £ 1 ULN; ASAT (SGOT) y ALAT (SGPT) £ 2,5 ULN; alkaline phosphatase £ 5 ULN. The patients which ASAT and/or ALAT value are > 1,5 ULN along with alkaline phosphatase value > 2,5 ULN will be not included into the study. Renal function: serum creatinine £ 175 µmol/l (2 mg/dl). If the value are borderline, clearance creatinine must be ≥ 60 ml/min 14. 12 weeks prior to randomization the following assessments and procedures must be fulfilled: Bilateral mammography; MRI Breast and axillary; Chest X-Ray (PA and lateral); Abdominal ultrasound; Chest CT-Scan; Abdominal CT-Scan. Bone Scan (if applicable) 15. Patients must be accessible for treatment and follow up Exclusion Criteria: 1. Patients with lumpectomy, partial mastectomy, modified radical mastectomy are not allowed to include into study. 2. Prior Immunotherapy, hormonal therapy and chemotherapy for breast cancer is not allowed. 3. Prior therapy with anthracycline and taxanes ( paclitaxel and docetaxel) is not permitted for any neoplasia. 4. Prior radiotherapy for breast cancer. 5. Bilateral invasive breast carcinoma 6. Pregnant or nursing patients. Negative pregnant test ( serum or urine) 14 days prior to randomization. 7. HER 2 negative breast cancer 8. Patients of childbearing potential must be use adequate contraceptive measures during study treatment. No hormonal contraceptive measure is permitted. 9. Any M1 breast cancer 10. Any motor or sensorial neurotoxicity grade ≥ 2 according to CTC criteria version 3. 11. 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 12. 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. 13. Long term treatment with corticoids except 6 months prior to inclusion in the study and low doses ( £ 20 mg metilprednisolone or equivalent ) 14. Corticoid use contraindication 15. Concomitant hormonal replacement therapy. Previous treatment should be interrupted before inclusion into study. 16. Cardiopathy what stops patient taking Docetaxel and Herceptin: myocardial infarction recorded; angina pectoris requiring specific treatment; any congestive heart failure recorded; arrhythmia grade 3 or 4 according to CTC ver.3; any relevant valvular disease; chest X ray which shows cardiomegaly or EKG which shows ventricular hypertrophy unless FEVI value has been upper URL in the last 3 months. 17. Poorly controlled hypertension ( systolic > 180 mm Hg or diastolic > 100 mm Hg). The patients with controlled hypertension under treatment can be included into study 18. 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. 19. The patient must interrupt concomitant treatment with hormonal therapy ej. raloxifen, tamoxifen and selective estrogen receptor modulators (SERM) prior to randomization. 20. Concomitant use of inhibitors and inductors of enzyme CYP3A4 complex ( ketoconazol, itraconazol 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. 21. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial within 30 days prior to randomization into study. 22. Concomitant treatment with other anticancer therapy 23. Hypersensitivity reaction to drugs herceptin, lapatinib or their excipients. 24. Male

Additional Information

Official title A Phase II Randomised, Multicentre Compare Epirubicine and Cyclophosphamide Treatment Plus Docetaxel and Trastuzumab Versus Epirubicine and Cyclophosphamide Treatment Plus Docetaxel and Lapatinib in Women With Primary Resectable Breast Cancer or Locally Advanced Breast Cancer Positive Her 2.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Spanish Breast Cancer Research Group.