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Closed (no longer recruiting)Last updated: 20 December 2023

PRE-TREAT: This study is trying to determine the effects of having short term endocrine therapy (tamoxifen or letrozole) in the treatment of newly diagnosed oestrogen receptor positive breast cancerA 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

Clinical summary

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.

Conditions

This trial is treating patients with oestrogen receptor positive breast cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

Not applicable

Trial Acronym

PRE-TREAT

More information

Trial Identifiers

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Trial sponsor

Royal Melbourne Hospital

Scientific Title

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

Eligibility

Inclusion

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

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

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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