A pre-surgery trial looking at the effect of combining megestrol acetate with letrozole or letrozole alone for postmenopausal patients with early, oestrogen receptor positive breast cancer

Phase 2

• Conditions: ER-positive breast cancer in post-menopausal patients; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN15621797
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-26
• Last Update Posted: 16 February 2021
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 189

Inclusion Criteria

1. Histologically confirmed breast adenocarcinoma
2. Postmenopausal women, defined as having experienced:
2.1. 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. =50 years, history of vasomotor symptoms) or
2.2. Six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL or
2.3. Surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.
3. Core biopsy confirmation of ER positive (Allred=3) and HER2 negative invasive carcinoma on core biopsy, >=T1c, either cN0 or N+
4. Patients whose cancers have been deemed to be operable by the MDT
5. Surgery planned within the next 2-6 weeks
6. ECOG performance status of 0, 1 or 2
7. Adequate Liver, Renal and Bone marrow function, defined as:
7.1. Adequate liver function where bilirubin is =1.5 x ULN
7.2. Adequate renal function with estimated creatinine clearance of =60 ml/min
7.3. Adequate bone marrow function with ANC =1.0 x 10(9)/L and Platelet count =100 x 10(9)/L
8. Written informed consent to participate in the trial and to donation of tissue

Exclusion Criteria

1. History of hormone replacement therapy in the last 6 months
2. Previous treatment with tamoxifen or an aromatase inhibitor in the last 6 months
3. Known hypersensitivity or contraindications to aromatase inhibitors or megestrol acetate
4. Known allergy to lactose
5. Known to have a progestogen-containing intrauterine system in situ, unless removed prior to randomisation
6. Known metastatic disease on presentation
7. Recurrent breast cancer (patients with a new primary invasive breast cancer will be eligible to participate)
8. 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
9. Treatment with an investigational drug within 4 weeks before randomization
10. Inability to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the trial medication
11. Inability to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in tumour proliferation is measured using Ki67 immuno-histochemical (IHC) assessment between pre-treatment (baseline) and post-treatment tumour samples (Day 15).