PIONEER- A pre-surgical window study of letrozole plus megestrol acetate versus letrozole alone in post-menopausal patients with ER-positive breast cancer

Phase 1

• Conditions: ER-positive, HER2-negative, invasive primary breast cancer of at least 1 cm size; MedDRA version: 21.1 Level: PT Classification code 10070577 Term: Oestrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003752-79-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-03
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 189

Inclusion Criteria

Inclusion Criteria
To be included in the trial the patient must:

•Histologically confirmed breast adenocarcinoma
•Postmenopausal women, defined as having experienced:
-12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. =50 years, history of vasomotor symptoms) or
-six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL or
-surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.
•Core biopsy confirmation of ER positive (Allred=3) and HER2 negative invasive carcinoma on core biopsy, >=T1c, either cN0 or N+
•Patients whose cancers have been deemed to be operable by the MDT
•Surgery planned within the next 2-6 weeks
•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 estimated creatinine clearance of =60 ml/min
-Adequate bone marrow function with ANC =1.0 x 109/L and Platelet count =100 x 109/L
•Written informed consent to participate in the trial and to donation of tissue

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 114

Exclusion Criteria

Exclusion Criteria
The presence of any of the following will preclude patient inclusion:

•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 study, at the discretion of the investigator
•Treatment with an investigational drug within 4 weeks before randomization
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified