Advanced Breast Cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
The patients will be allocated to a treatment using a minimisation algorithm. Stratification factors will be:
1. AI sensitivity strata
2. Disease site (bone metastases
Sponsors
The Common Services Agency (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females who are clearly post menopausal with Estrogen Receptor (ER) positive (Allred score = 3) advanced breast cancer with at least one lesion which is measurable. They may also have additional evaluable but non-measurable lesions. 2. Patients must be performance status 0 ? 2 3. Suitable for treatment with an aromatase inhibitor 4. Life expectancy > 3 months 5. Cancer must be HER2- (by FISH and/or IHC as appropriate), OR if the cancer is HER2+ the patient must not be a candidate for ant-HER2 therapy 6. All patients will need to also meet inclusion criteria for one of the two main strata: 6.1. ?AI-sensitive/naive? group ? either never previously treated with an aromatase inhibitor, but if treated with tamoxifen must not have rapid progression on tamoxifen (i.e. treated for at least 24 months adjuvant or = 6 months in metastatic setting); or, if previously treated with an AI, only in the adjuvant or neo-adjuvant setting AND have remained free of progression for at least 12 months whilst not being treated with an AI 6.2. ?Prior AI? group ? patients NOT meeting the criteria in 6.1 (above), but previously treated with a non-steroidal AI without progression for at least 24 months in the (neo-) adjuvant setting or for at least 6 months for advanced disease 7. Patients who have had two lines of prior AI therapy will not be eligible UNLESS they were switched from one AI to another ONLY for reasons of toxicity, and ONLY during (neo-) adjuvant therapy AND in the absence of any evidence of progression/relapse 8. Single site of bone disease must be histologically confirmed and known not to be ER negative 9. Palliative radiotherapy can be given to bone lesions within 4 weeks of trial entry provided not more than 20% of the bone marrow is irradiated, AND there is at least one other measurable bone lesion which has clearly progressed since any prior irradiation 10. Haematology ? commensurate with a phase II hormonal therapy study: Neutrophils > 1.5 * 109/l, Hb> 10.0 g/dl and Platelets > 100 * 109/l 11. Biochemistry ? similar: albumin normal, ALT/AST 50ml/min 12. Normal urea & electrolytes 13. Patients receiving bisphosphonates are eligible, provided they are commenced before, or at, trial entry 14. Patients will be stratified by use of, or stated intention to give, bisphosphonate at randomisation 15. Patients ideally should have been on therapy for at least 1 week before starting trial therapy, but must start within 1 week after starting trial therapy
Exclusion criteria
Exclusion criteria: 1. Patients with short life expectancy or significant other co-morbidity including pulmonary fibrosis 2. Rapidly progressive visceral disease (lymphangitis, diffuse liver disease, uncontrolled CNS disease) 3. Resting ECG with a measureable QTc >480 msec 4. Any evidence of severe or uncontrolled systemic conditions (e.g. interstitial lung disease [bilateral, diffuse, parenchymal change]) 5. Life expectancy < 3 months 6. Contra-indication to either AZD0530 (or excipients) or aromatase inhibition 7. Concomitant chemotherapy or anti-HER2 therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 02/04/2019: Progression free survival will be measured using time to progression through standard, regular, clinical assessment. Previous primary outcome measure: 1. Progression free survival 2. Time to progression will be measured through standard, regular, clinical assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity 2. Change in tumour size analysed using a Waterfall plot in the two strata separately 3. Overall survival | — |
Countries
Scotland, United Kingdom
Outcome results
None listed