Status:
COMPLETED
A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Anticancer Fund, Belgium
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Around 75% of breast cancers are defined and driven by Oestrogen receptor alpha (ERα) transcriptional activity. Standard treatment is endocrine therapy however clinical outcomes vary considerably, and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT03306472
Start Date
July 20 2017
End Date
October 31 2023
Last Update
January 30 2024
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ