E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Breast carcinoma classified as cT1b,c, T2, T3, or cT4 a-c, cN0-2, N3, M0 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10006289 |
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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 |
In this study we will investigate the hypothesis that a reduction of 18F-FLT uptake in the tumor after the first cycle of neoadjuvant chemotherapy, compared to the baseline, may predict the response to the treatment. |
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E.2.2 | Secondary objectives of the trial |
- To compare proliferation index (Ki 67) with the uptake value of 18F-FLT. - To compare the changes in 18F-FLT uptake with those detected by pathologist in the tru-cut sample obtained after the first course of treatment (when performed). - To compare 18F-FLT uptake and 18-FDG uptake at the baseline. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Premenopausal or postmenopausal patients with histologically proven primary breast cancer aged < 75 years • Tumor classified as cT1b,c, T2, T3, or cT4 a-c, cN0-2, N3, M0 • Patients must have had a TRU-CUT biopsy. • c-erbB-2 expression must be known by immunohistochemistry • Patients must be suitable for preoperative therapy according to EIO guidelines or protocols • Patients must be informed of, and agree to, data and material transfer and handling, in accordance with national data protection guidelines • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion. • Patients must be accessible for follow-up. |
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E.4 | Principal exclusion criteria |
• Patients with distant metastases. • Patients with previous or concomitant malignancy except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, or contra- or ipsilateral in situ breast carcinoma. • Patients who have received prior therapy for breast cancer including prior irradiation, neoadjuvant chemotherapy or other preventative therapies. • Patients with non-malignant systemic diseases that would prevent them from undergoing any of the treatment options, or would prevent prolonged follow-up. • Patients who either have been pregnant or who have lactated within 6 months of diagnosis. • Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary aim of the study is to determine the association between tumor FLT uptake reduction after 3 weeks of treatment and the response to primary therapy, expressed in terms of pathological Complete Response (pCR) and partial response (PR) |
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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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
braccio unico controllo pre e post chemioterapia |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |