E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
oligometastatic breast cancer |
|
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 |
Phase I: To determine the maximum tolerated dose of local 3D conformal radiotherapy (3DCRT) to the metastatic sites for combined modality treatment with systemic paclitaxel weekly chemotherapy (80mg/m2), followed by systemic chemotherapy with paclitaxel weekly until a total of 8 weeks, in patients with oligometastatic breast cancer Phase II: To determine the effect of systemic paclitaxel weekly chemotherapy - with or without local 3DCRT to metastatic sites - on progression-free survival, as measured by the one-year progression-free survival rate in patients with oligometastatic brast cancer |
|
E.2.2 | Secondary objectives of the trial |
Phase I: To determine: - progression-free survival, as measured by the 9-month progression-free survival rate To describe: - objective tumor response rate (ORR), ccording to RECIST-Criteria - time to progression, as measured by the 1-, 2-, and 3-year progression-free-survival rates - toxicity - overall survival
Phase II: To determine: - progression-free survival, as measured by the 9-month progression-free survival rate To describe -time-to-progression, as measured by the 2- and 3-year progression-free-survival rates -toxicity -overall survival of combined systemic paclitaxel weekly chemotherapy, with or without local 3DCRT, followed by systemic paclitaxel weekly chemotherapy, in patients with oligometastatic breast cancer |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- women with histologically or cytologically confirmed, oligometastatic breast cancer (stage IV), defined as either </= 3 metastatic lesions, or primary tumor and </= 2 metastatic lesions if surgery is not considered as the treatment of choice - ER- and progesterone receptor (PgR)-negative status, hormone-refractory or rapid progressive disease. HER-2 positive patients are allowed only in the phase II-part of the study - failure of prior anthracycline therapy (unless contra-indicated) - adequate hematological, renal and liver function - age 18-75 years, ECOG performance status 0-1 - effective contraception |
|
E.4 | Principal exclusion criteria |
- patients with cerebral metastases, as well as metastases in anatomic proximity to peripheral nerves procluding the delivery of the planned radiochemotherapy - malignant ascites, pericardial or pleural effusions - uncontrolled concommitant malignancy - pregnant or lactating women - prior radiation to the metastatic sites - prior treatment with taxanes - known hypersensitivity to taxanes or Cremophor EL - patients with a history of grade III/IV peripheral neuropathy of any etiology - patients with diabetes mellitus and a peripheral neuropathy > grade I |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Phase I: Maximum tolerated dose of local 3DCRT to metastatic sites in the proposed combined medality treatment
Phase II: Progression-free-survival in both study arms, as measured by the one-year progression-free survival rate |
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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 | 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 | Information not present in EudraCT |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
First application of weekly paclitaxel in combination with local 3DCRT to metastatic sites |
|
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | Yes |
E.8.2.3.1 | Comparator description |
Weekly paclitaxel without local 3DCRT to metastatic sites |
|
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 | 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 | 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
|
3 years after randomisation (see protocol) |
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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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |