E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer |
Soggetti con carcinoma mammario HER2+ AR+ metastatico o localmente avanzato |
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E.1.1.1 | Medical condition in easily understood language |
Female subjects with metastatic or locally advanced breast cancer |
Donne con carcinoma mammario metastatico o localmente avanzato |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065430 |
E.1.2 | Term | HER-2 positive breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027475 |
E.1.2 | Term | Metastatic breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072740 |
E.1.2 | Term | Locally advanced breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
To evaluate the efficacy of enzalutamide with trastuzumab in evaluable subjects with human epidermal growth factor receptor 2 positive (HER2+), androgen receptor positive (AR+) and estrogen receptor negative (ER-)/progesterone receptor negative (PgR-), metastatic or locally advanced breast cancer |
Valutare l’efficacia di enzalutamide con trastuzumab in soggetti valutabili con carcinoma mammario metastatico o localmente avanzato e recettore del fattore di crescita epiteliale umano 2 positivo (HER2+), recettore degli androgeni positivo (AR+), recettore di estrogeni/progesterone negativi (ER-)/(PgR-). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the following efficacy measures:
o Best Overall Response Rate (BORR)
o Overall Response Rate (ORR) at 24 weeks
o Progression Free Survival (PFS)
o Time to Progression (TTP)
o Duration of Response (DOR)
o Time to Response (TTR)
o To evaluate safety and tolerability. |
Valutare i seguenti parametri di efficacia:
- Migliore tasso di risposta globale (BORR, Best Overall Response Rate)
- Tasso di risposta globale (ORR, Overall Response Rate) a 24 settimane
- Sopravvivenza libera da progressione (PFS, Progression Free Survival)
- Tempo alla progressione (TTP, Time to Progression)
- Durata della risposta (DOR, Duration of Response)
- Tempo alla risposta (TTR, Time to Response)
- Valutare sicurezza e tollerabilità
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Please refer to protocol for principal inclusion criteria |
Fare riferimento al protocollo per i principali criteri di inclusione |
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E.4 | Principal exclusion criteria |
Please refer to protocol for principal exlusion criteria |
Fare riferimento al protocollo per i principali criteri di esclusione |
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E.5 End points |
E.5.1 | Primary end point(s) |
CBR defined as the proportion of subjects with best objective response of CR, PR or SD at ≥ 24 weeks according to RECIST 1.1 criteria. |
Tasso di Beneficio Clinico (CBC, Clinical Benefit Rate) definito dalla proporzione di soggetti con migliore risposta obiettiva di RC, RP o MS a ≥24 settimane in base al criterio 1.1 dei RECIST. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
up to 2 years |
Fino a 2 anni |
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E.5.2 | Secondary end point(s) |
Overall response rate (CR+PR) according to RECIST 1.1 criteria
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Tasso di risposta globale (ORR, Overall Response Rate) (RC+RP) in base al criterio 1.1 dei RECIST. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
up to 2 years |
Fino a 2 anni |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 24 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 | No |
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 |
Belgium |
Canada |
Ireland |
Italy |
Russian Federation |
Spain |
United Kingdom |
United States |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |