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

PRE-TREAT - A window study to determine short-term effects of Pre-operative Treatment with tamoxifen or letrozole on the expression of pro-survival genes in oestrogen receptor (ER) positive breast cancer

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000695606

Acronym

Pre-Treat

Enrollment

Registered

2014-07-02

Start date

2014-12-23

Completion date

2019-08-19

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine the effects of short-term treatment with endocrine therapy (tamoxifen or letrozole) when given to women with newly diagnosed oestrogen receptor positive (ER+) breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above, have been recently diagnosed with oestrogen-receptor positive breast cancer. Eligible candidates must have already provided consent to be part of the Breast Biomarker Project at Royal Melbourne Hospital. Study details All participants in this study will receive endocrine therapy for 5-7 days prior to surgery. Pre- or peri- menopausal women will receive 20mg oral tablet of tamoxifen per day whilst post-menopausal women will receive 2.5mg oral tablet of letrozole per day. Blood and tumour samples taken at the time of diagnosis will be compared to those taken at the time of surgery to determine changes in the tumour cells. The findings from this study will provide valuable information on the changes in breast cancer cells and their "signatures" following short-term exposure to endocrine therapy, and help with development of future breast cancer treatment.

Interventions

Tamoxifen for pre- or peri-menopausal women 20mg oral once daily for 5-7 days before surgery Letrozole for post-menopausal women 2.5mg oral once daily for 5-7 days before surgery All unadministered tablets will be returned. Patients will also be asked about compliance to treatment.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results