E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Early Stage Breast Cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057654 |
E.1.2 | Term | Breast cancer female |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to determine whether adjuvant therapy with lapatinib will improve disease-free survival in women with early-stage ErbB2-overexpressing breast cancer. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate and compare between treatment arms the following overall survival; recurrence-free intervals local, regional, distant, and central nervous system CNS ; the rate of CNS recurrence; toxicities; and quality of life, as physical and mental health status. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Have histologically or cytologically confirmed ErbB2-overexpressing invasive carcinoma Tx or T1-4 of the breast at the time of the initial diagnosis and have undergone adequate excision of tumor; 2.ad tumors that overexpress ErbB2 - 3. Using the American Joint Committee on Cancer 6th edition staging criteria for breast cancer Greene, 2002 refer to Section 14.3, Appendix 3 , a woman must have Stage I through Stage IIIb disease - 4. Women with synchronous bilateral invasive breast cancer or synchronous DCIS of either the contralateral or ipsilateral breast at the time of the initial diagnosis are also eligible- 5. Have completed all primary adjuvant chemotherapy regimens prior to study enrollment. However, adjuvant endocrine therapy and radiotherapy may continue as described in Inclusion Criteria 11 and 13- 7. Have clinical and radiologic assessments that are negative for local or regional recurrence of disease or metastatic disease at the time of study entry - 9. Have undergone either total mastectomy OR lumpectomy - 16.Have a cardiac ejection fraction within institutional range of normal as measured by either echocardiogram or multigated acquisition MUGA scans. - |
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E.4 | Principal exclusion criteria |
1. Have clinical and radiologic evidence of local or regional recurrence of disease or metastatic disease at the time of study entry; 2. Had metachronous invasive breast cancer breast cancers diagnosed at different times ; 3. Have a prior history of other breast cancer malignancies, including DCIS; 4. Are unable to provide archived tumor tissue samples for assay; 5. Had prior therapy with an ErbB1 and/or ErbB2 inhibitor; 7. Have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment; 8. Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded; 12. Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF; |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint for analysis is disease-free survival DFS which includes the following events local recurrence following mastectomy,local recurrence in ipsilateral breast following lumpectomy,regional recurrence,distant recurrence,contralateral breast cancer, including ductal carcinoma in situ DCIS ,other second primary cancer excluding squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or lobular carcinoma in situ of the breast ;death from any cause without prior event recurrence of breast cancer or second primary cancer |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |