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Trial record 74 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00841828
Recruitment Status : Completed
First Posted : February 11, 2009
Results First Posted : November 2, 2018
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Lapatinib Drug: Trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Experimental
Epirubicin + Cyclophosphamide -> Docetaxel + Lapatinib
Drug: Epirubicin
Other Names:
  • Ellence
  • Pharmorubicin

Drug: Cyclophosphamide
Other Names:
  • Cytoxan
  • Neosar
  • Endoxan

Drug: Docetaxel
Other Name: Taxotere

Drug: Lapatinib
Other Name: Tykerb

Active Comparator: Control
Epirubicin + Cyclophosphamide -> Docetaxel + Trastuzumab
Drug: Epirubicin
Other Names:
  • Ellence
  • Pharmorubicin

Drug: Cyclophosphamide
Other Names:
  • Cytoxan
  • Neosar
  • Endoxan

Drug: Docetaxel
Other Name: Taxotere

Drug: Trastuzumab
Other Name: Herceptin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Overall Clinical Response Rate (ORR) [ Time Frame: Up to 12 weeks ]

    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 immunohistochemistry (IHQ) 3+ or positive FISH. When IHQ 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 World Health Organization (WHO) performance status of 0 or 1 (Karnofsky ≥ 80)
  10. Age > 18 years.
  11. Absence of metastases disease
  12. 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
  13. 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

  14. 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)
  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 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 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 methylprednisolone 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 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.
  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. raloxifene, tamoxifen and selective estrogen receptor modulators (SERM) prior to randomization.
  20. 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.
  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 trastuzumab, lapatinib or their excipients.
  24. Male

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00841828

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Hospital Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital General de Granollers
Granollers, Barcelona, Spain, 08400
Xarxa Asistencial de Manresa
Manresa, Barcelona, Spain, 08243
Corporación Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital del Espíritu Santo
Santa Coloma De Gramenet, Barcelona, Spain, 08923
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Donostia-San Sebastián, Guipuzcoa, Spain, 20012
Hospital Xeral Cíes
Vigo, Pontevedra, Spain, 36204
Hospital Universitario de Canarias
La Laguna, Santa Cruz De Tenerife, Spain, 38320
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Centro Oncológico de Galicia
A Coruña, Spain, 15009
Hospital del Mar
Barcelona, Spain, 08003
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital General Yagüe
Burgos, Spain, 09005
Complejo Hospitalario San Pedro de Alcántara
Cáceres, Spain, 10003
Complejo Hospitalario Universitario Reina Sofía
Córdoba, Spain, 14004
Complejo Hospitalario de Jaén
Jaén, Spain, 23007
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain, 29010
Hospital Virgen de la Salud
Toledo, Spain, 45004
Hospital Universitario La Fe
Valencia, Spain, 46009
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Spanish Breast Cancer Research Group
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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

Additional Information:
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Responsible Party: Spanish Breast Cancer Research Group Identifier: NCT00841828     History of Changes
Other Study ID Numbers: GEICAM/2006-14
2007-007031-13 ( EudraCT Number )
First Posted: February 11, 2009    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: January 9, 2019
Last Verified: January 2019

Keywords provided by Spanish Breast Cancer Research Group:
HER2-positive breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors