Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients
This trial is active, not recruiting.
|Treatment||epirubicin, cyclophosphamide, taxotere, herceptín, lapatinib|
|Phase||phase 2/phase 3|
|Sponsor||Spanish Breast Cancer Research Group|
|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|
|Badalona, Spain||Hospital Germans Trias i Pujol||no longer recruiting|
|Granollers, Spain||Hospital General de Granollers||no longer recruiting|
|Manresa, Spain||Xarxa Asistencial de Manresa||no longer recruiting|
|Sabadell, Spain||Corporación Sanitaria Parc Taulí||no longer recruiting|
|Santa Coloma de Gramanet, Spain||Hospital del Espíritu Santo||no longer recruiting|
|Tarrasa, Spain||Hospital Mutua de Terrasa||no longer recruiting|
|Tarrasa, Spain||Consorci Sanitari de Terrasa||no longer recruiting|
|Vigo, Spain||Hospital Xeral Cíes||no longer recruiting|
|La Laguna, Spain||Hospital Universitario de Canarias||no longer recruiting|
|A Coruña, Spain||Complejo Hospitalario Universitario A Coruña||no longer recruiting|
|A Coruña, Spain||Centro Oncológico de Galicia||no longer recruiting|
|Barcelona, Spain||Hospital Clinic i Provincial||no longer recruiting|
|Barcelona, Spain||Hospital de la Santa Creu i Sant Pau||no longer recruiting|
|Barcelona, Spain||Hospital del Mar||no longer recruiting|
|Burgos, Spain||Hospital General Yagüe||no longer recruiting|
|Cáceres, Spain||Complejo Hospitalario San Pedro de Alcántara||no longer recruiting|
|Córdoba, Spain||Hospital Provincial de Córdoba||no longer recruiting|
|Jaén, Spain||Complejo Hospitalario de Jaén||no longer recruiting|
|Madrid, Spain||Hospital de la Princesa||no longer recruiting|
|Málaga, Spain||Hospital Universitario Virgen de la Victoria||no longer recruiting|
|Oviedo, Spain||Hospital Central de Asturias||no longer recruiting|
|San Sebastián, Spain||Instituto Oncológico de Guipúzcoa||no longer recruiting|
|Toledo, Spain||Hospital Virgen de la Salud||no longer recruiting|
|Valencia, Spain||Hospital Universitario La Fe||no longer recruiting|
|Valencia, Spain||Hospital Clinico de Valencia||no longer recruiting|
|Valencia, Spain||Instituto Valenciano de Oncología||no longer recruiting|
|Zaragoza, Spain||Hospital Miguel Servet||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Complete pathological response Rate
time frame: Within 3-4 weeks after last docetaxel dose, surgery will be performed to evaluate pathological response
time frame: After each treatment cycle
Female participants at least 18 years old.
- 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 IHC 3+ or positive FISH. When IHC 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.
- 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 WHO performance status of 0 or 1 ( Karnofsky ³ 80)
- Age > 18 years.
- Absence of metastases disease
- Baseline EKG 12 weeks prior to randomization. Baseline 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; 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
- 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)
- Patients must be accessible for treatment and follow up
- 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.
- 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 CTC criteria 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 metilprednisolone 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 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.
- 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. raloxifen, tamoxifen and selective estrogen receptor modulators (SERM) prior to randomization.
- 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.
- 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 herceptin, lapatinib or their excipients.
|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.|
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