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This study looked at giving Letrozole together with Megestrol Acetate (a progesterone-receptor agonist) compared with Letrozole alone, in the short pre-operative window, in post-menopausal women with estrogen-receptor-positive (ER-positive) breast cancer. It enrolled post-menopausal women with histologically confirmed, ER-positive, HER2-negative breast cancer. The trial was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Histologically confirmed breast adenocarcinoma * Postmenopausal women * Core biopsy confirmation of invasive carcinoma on core biopsy, ≥T1c, either clinical NX or N0-N3 * ER positive (Allred≥3) and HER2 negative * 2 groups of patients are potentially eligible: * Cohort A: Patients whose cancers have been deemed to be operable by the Multi-Disciplinary Team (MDT), with surgery planned for the next 2-6 weeks * Cohort B: Patients with early or locoregionally advanced breast cancer planned for primary endocrine therapy, either in lieu of surgery or as neoadjuvant therapy prior to surgery- such patients must begin PIONEER trial therapy prior to starting any other endocrine therapy. * ECOG performance status of 0, 1 or 2 * Adequate Liver, Renal and Bone marrow function, defined as: * Adequate liver function where bilirubin is ≤1.5 x ULN * Adequate renal function with serum creatinine ≤ 1.5 x ULN * Adequate bone marrow function with ANC ≥1.0 x 10\*9/L and Platelet count ≥100 x 10\*9/L * Written informed consent to participate in the trial and to donation of tissue Exclusion Criteria: * History of hormone replacement therapy in the last 6 months * Previous treatment with Tamoxifen or an aromatase inhibitor in the last six months * Known hypersensitivity or contraindications to aromatase inhibitors or Megestrol acetate * Known allergy to lactose * Known to have a progestogen-containing intrauterine system in situ, unless removed prior to randomisation * Known metastatic disease on presentation * Recurrent breast cancer (patients with a new primary invasive breast cancer will be eligible to participate) * Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the trial, at the discretion of the investigator * Treatment with an investigational drug within 4 weeks before randomisation * Inability to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the trial medication * Inability to give informed consent