Study design and patients
Tumors, ovarian suppression
BONE LESION, DISEASE PROGRESSION, RECURRENCE, METASTASIS, DISEASE, TUMORS, MAY, ONCOLOGY, METASTATIC BREAST CANCER
This was a double-blind, randomised, placebo-controlled, Phase II trial, with potential seamless expansion to a confirmatory Phase III trial. Enrolment occurred between 15 May 2019 and 16 April 2021. Eligible patients were adult females diagnosed with histologically and centrally confirmed HR-positive/HER2-negative advanced or metastatic breast cancer not deemed amenable to curative surgery or radiation therapy. Patients were premenopausal receiving ovarian suppression or postmenopausal and must have experienced disease recurrence ≤ 12 months after completion of adjuvant endocrine therapy or had disease progression ≤ 1 month after the end of prior endocrine therapy for advanced breast cancer. Patients had to have at least one measurable non-visceral lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in either lymph nodes, soft tissue, skin and/or at least one measurable non-visceral bone lesion and/or at least one non-measurable bone lesion. In addition, patients should have Eastern Cooperative Oncology Group performance status of 0 or 1, fasting glucose < 8.9 mmol/L and HbA1c < 8.0%, and adequate organ function.Key exclusion criteria were: evidence of visceral metastasis at screening; prior treatment with agents targeting the IGF, AKT or mTOR pathways or prior exemestane (prior treatment with a PI3K inhibitor, however, was not an exclusion criterion [