E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Estrogen Receptor-positive metastatic breast cancer patients that will be treated with fulvestrant |
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E.1.1.1 | Medical condition in easily understood language |
hormone responsive metastasized breast cancer patients |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] |
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 |
- To visualize and quantify FES uptake in tumor lesions before and during fulvestrant 500 mg every 28 days
- To evaluate the proportion of patients with an incomplete down-regulation/ occupancy of ERs
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E.2.2 | Secondary objectives of the trial |
- The feasibility to quantify FES uptake in liver metastases
- To correlate FES-PET results to tumor response on fulvestrant therapy
- To correlate total tumor burden, pre-treatment ER-expression, plasma fulvestrant levels and plasma estradiol levels with tracer uptake.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with a history of histological proven ER-positive primary breast cancer and, whenever available, histological proven ER-positive recurrence.
2. Post-menopausal status (age ≥ 45 years with amenorrhea for > 12 months [with or without concomitant use of LHRH-/GNRH-agonists] or prior bilateral ovariectomy
3. Documentation of a negative pregnancy test must be available for women less than 2 years after menopause
4. Progressive disease after 2 lines of hormonal therapy
5. No previous fulvestrant treatment
6. ER-antagonists should be discontinued for 5 weeks prior to FES-PET to prevent false negative FES_PET results. Use of aromatase inhibitors is allowed
7. At least one measurable lesion according to RECIST v1.1 that is localized outside of the liver
8. ECOG performance status 0, 1 or 2
9. Life expectancy > 3 months
10. Creatinine clearance ≥ 30 ml/min
11. Age ≥ 18 years
12. Signed written informed consent
13. Able to comply with the protocol |
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E.4 | Principal exclusion criteria |
1. Evidence of central nervous system metastases
2. Presence of life-threatening visceral metastases
3. > 3 lines of endocrine therapy for metastatic disease
4. > 2 lines of chemotherapy in metastatic disease
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E.5 End points |
E.5.1 | Primary end point(s) |
This is a feasibility/ pilot study
- to quantify the absolute and relative differences in FES tracer uptake during fulvestrant therapy, compared to the tracer uptake prior to the start of fulvestrant.
- to determine the proportion of patients with a sub-optimal blockage/ downregulation of the ER. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
FES uptake will be calculated at baseline (prior to F therapy), after 1 month and after 3 months. |
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E.5.2 | Secondary end point(s) |
- The feasibility to quantify FES uptake in liver metastases
- To correlate FES-PET results to tumor response on fulvestrant therapy
- To correlate total tumor burden, pre-treatment ER-expression, plasma fulvestrant levels and plasma estradiol levels with tracer uptake. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |