Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
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 people with oestrogen receptor 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 (localised).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
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
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information