E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients will be ER and/or PR-positive, axillary node negative, HER2 negative breast cancer patients. |
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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 | PT |
E.1.2 | Classification code | 10057654 |
E.1.2 | Term | Breast cancer female |
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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 |
The TAILORx study aims to determine whether adjuvant hormone therapy is not inferior to adjuvant chemohormonal therapy in women whose tumours meet established clinical guidelines for adjuvant chemotherapy and fall in the Oncotype DX Recurrance Score 11-25. The primary endpoint is disease free survival and patients will be followed for 20 years. |
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E.2.2 | Secondary objectives of the trial |
- to determine whether adjuvant hormone therapy is sufficient treatment for women whose tumours meet established clinical guidelines for adjuvant chemotherapy who fall into the “low risk” category, Oncotype DX Recurrance Score <11.
- to compare the outcomes at ten years by Adjuvant with those made by the Genomic Health Obcotype DX test.
- to establish failure rates as a function of Recurrance Score separately in the chemotherapy and no chemotherapy groups.
- to determine the prognostic significance of the Oncotype DX recurrence score and the individual Recurrance Score gener groups.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with operable histrologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment. - Patients will be ER and/or PR-positive. - Patients will be axillary node negative. - The patients tumor size will be 1.1-5.0cm or 5mm-1cm plus unfavourable histological features. - The tumour must be HER2 negative. - A tissue specimen from the primary breast cancer must be available for sending to Genomic Health for analysis. - Patients must be aged 18-75 years. - Patients must have adequate organ functioning.
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E.4 | Principal exclusion criteria |
- invasive malignancies in the last 5 years with the exception of curatively treated basel cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. - greater than 84 days from the final surgical procedure required to treat the primary tumour. - less than 1mm tumour-free margin of resection. - prior chemotherapy for this malignancy - prior radiation therapy for this malignancy - patients who develop breast cancer while receiving a selective estrogen-receptor modulator (SERM) or an aromatase inhibitor for breast cancer prevention or a SERM for other indications. However patients may have received 8 weeks of a SERM or aromatase inhibitor for this malignancy and still be eligible for this study. - patients with an anticipated life expectancy of less than 10 years - patients with chronic obstructive pulmonary disease requiring treatment - patients with chronic liver disease - patients with previous history of cerebrovascular accident. - patients with a history of congestive heart failure or other cardiac disease that would represent a contraindication to the use of an anthracycline - patients with a chronic psychotic condition or other condition that would impair compliance with the treatment regimen. - pregnant or nursing women. - patients who have had previous Oncotype DX assay performed, with the exception of patients who have had the assay performed and have a Recurrence Score of 11-25.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | Yes |
E.6.12 | Pharmacoeconomic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
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 | 13 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 |
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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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The trial will end when all patients have been followed up for 20 years post the time of their randomisation into the study. |
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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 | 25 |
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 | 25 |
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 |