PRE-TREAT: A window study evaluating short term treatment with tamoxifen or letrozole in oestrogen receptive positive breast cancer

Not Applicable

Completed

• Conditions: Cancer - Breast; Breast cancer

• Registration Number: ACTRN12614000695606
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-02
• Study Completion: 2020-03-31
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

1. Female
2. Histologically confirmed invasive ductal or lobular carcinoma of the breast
3. Consented to Breast Biomarker Project (TransBCR MH HREC No:2013.025)
4. Oestrogen-positive breast cancer, defined as ++ to +++, i.e. moderate to strong tumour immunostaining in >20% of the tumour cells
5. Intention to treat with surgery
6. ECOG 0-1

Exclusion Criteria

1. Known metastatic breast cancer
2. Previous invasive carcinoma of the breast
3. Pregnancy or lactation
4. Subjects deemed to require any neoadjuvant therapy prior to definitive surgery
5. Concurrent therapy with a Selective Oestrogen Receptor Modulator (SERM), aromatase inhibitor or pure ER antagonist e.g. fulvestrant
6. Prior endocrine therapy or chemotherapy
7. Contraindication to tamoxifen use for tamoxifen arm (past or strong family history of venous thromboembolic events, BMI>35, planned surgery >4 hours)
8. Current anti-coagulation therapy for thromboembolic event
9. History of severe osteoporosis defined by osteoporosis-related fractures or limiting activities of daily living in post-menopausal women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global changes in mRNA expression, including BCL-2 family members, following short-term treatment with tamoxifen or letrozole in ER-positive breast cancer. This will be assessed by gene expression profiling and RT-PCR on paired tumour samples obtained at diagnosis and at the time of surgery.[At baseline (diagnosis) and after 5-7 days of treatment (at surgery)]

Secondary Outcome Measures

Name	Time	Method
Changes in BCL-2 protein by gene expression profiling and RT-PCR on paired tumour samples.[At baseline and at surgery (after 5-7 days of treatment)];Changes in ER and PR expression using immunohistochemistry[At baseline and at surgery (after 5-7 days of treatment)];Changes in Ki67 expression using immunohistochemistry[At baseline and at surgery (after 5-7 days of treatment)]