E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with primary breast cancer and new primary or recurrent breast cancer |
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MedDRA Classification |
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 |
Evaluation of tumour response to treatment with Lapatinib |
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E.2.2 | Secondary objectives of the trial |
-Assessment of intra-tumoural biomarkers before and at the end of Lapatinib treatment. - Safety. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PET imaging sub-study to detect early response to Lapatinib in patients with primary breast cancer. |
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E.3 | Principal inclusion criteria |
-Patients must have histologically or cytologically confirmed primary breast cancer, or new primary, or recurrent.
-The carcinoma can be ER positive or ER negative and must be EGFR positive as defined by positive immuno-staining with antibodies agains EGFR.
- 2 cohorts of patients will be enrolled. Patients in the control arm will be ER+, EGFR+ and patients in the experimental arm will be ER-ve, EGFR+ve. All patients will be erbB2 negative.
-Patients must have measurable breast cancer, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10mm with ultrasound.
-No prior chemotherapy for breast cancer if given less than two years ago.
- Age > or = to 18 years.
- Life expectancy of greater than 12 weeks
--ECOG performance status 2
- Patients must have normal organ and marrow function as defined in the protocol.
- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram.
- Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of Lapatinib will be determined following review of their use by the Principal Investigator.
- Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Able to give written informed consent.
- Able to swallow and retain oral medication.
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E.4 | Principal exclusion criteria |
- Patients who have had any chemotherapy within the last 2 years.
- Patients who have had prior treatment with EGFR targeting therapies.
- Patients with metastatic disease.
- Patients with erbB2+++
- Patients who have rapidly progressive local disease, or local disease that, in the opinion of the investigator, is not amenable to surgical resection.
- Pregnant women |
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E.5 End points |
E.5.1 | Primary end point(s) |
RECIST response by ultrasound measurement. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |