Eligibility & exclusion criteria
Allred, bone-only disease, toxicity, ER-positive disease, visceral disease, post-menopausal state,
DISEASE, INTERSTITIAL LUNG DISEASE, METASTATIC DISEASE
Eligible participants were women with advanced breast cancer suitable for 1st or 2nd line of hormonal treatment. Main eligibility criteria included post-menopausal state, ER-positive disease (Allred score ≥ 3), incurable metastatic disease with at least one measurable lesion, performance status 0–2, life expectancy of > 3 months, HER2 negative (by IHC and/or FISH) or HER2 positive but not a candidate for anti-HER2 therapy, biopsy-confirmed ER-positive disease if bone-only disease and satisfactory haematology/biochemistry results.Patients also had to meet inclusion criteria for one of the two strata of either “AI-sensitive/naïve” or “prior-AI”. In the “AI-sensitive/naïve” group, patients either had never had an AI (but were permitted to have had prior tamoxifen without rapid progression, defined as having had ≥ 24 months of treatment in the adjuvant setting or ≥ 6 months treatment in the metastatic setting), or had received AI in the adjuvant/neoadjuvant setting (with no progression for at least 12 months whilst not being an on AI). In the “prior-AI” group, they had previously been treated with a non-steroidal AI without rapid progression (that is, for at least 24 months in neoadjuvant/adjuvant setting or 6 months for advanced disease). Patients who had two prior lines of AI therapy were ineligible, unless they switched from one AI to another only due to toxicity in the neoadjuvant/adjuvant setting in the absence of any progression/relapse. Prior chemotherapy in the metastatic setting was allowed and a history of palliative radiotherapy within 4 weeks of trial entry was allowed (provided ≤ 20% of bone marrow was irradiated and there was at least one other progressive measurable bone lesion).Exclusion criteria included significant co-morbidity, interstitial lung disease, rapidly progressive visceral disease, QTc prolongation, CYP3A4 interactions, contraindication to AZD0530 or AI, and pregnancy/lactation. Concomitant chemotherapy and anti-HER2 therapy were not allowed. However, patients receiving bisphosphonates were eligible, provided these were commenced before, or at, trial entry.