Randomised phase II trial of neoadjuvant chemotherapy +/- concurrent aromatase inhibitor endocrine therapy to down-stage large oestrogen receptor positive breast cancer (ANZ 1401 ELIMINATE)

Breast Cancer Trials (BCT)

Dataset description

* Dataset of 134 women with ER-positive, HER2-negative grade 2/3 invasive breast cancer greater than 20mm. *Randomised 2:1 to receive either standard neoadjuvant chemotherapy concurrently with aromatase inhibitor (89 patients) or standard neoadjuvant chemotherapy only (45 patients) for 18-24 weeks. * Rate of downstaging to pathologic stage 0 or 1A, pCR at time of surgery data. * Median breast tumour volume percentage decrease, rate of breast conserving surgery, SAE rates data.
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Chemotherapy |

Source Study


Government body,National Health and Medical Research Council

Scientific enquiries

Dr Nicholas Murray

Brief Summary

This study aims to add hormone treatment (aromatase inhibitor (letrozole)) to standard neoadjuvant chemotherapy and find out if this treatment is more effective in reducing the size of large breast cancers before surgery. More effective down-staging of large breast cancers before surgery increases the likelihood of achieving a complete surgical resection and can increase the rate of breast conserving surgery. Who is it for? You may be eligible for this study if you have ER-positive, HER2-negativ ....
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Key Inclusion Criteria

* Female >= 18 years. * Intact histologically confirmed grade 2 or 3 invasive breast cancer on core biopsy. * ER positive (>= 10% cells) on core biopsy. * HER2 negative (IHC 0 or 1+ or ISH negative breast cancer on core biopsy). Negative ISH test is required if HER2 testing shows IHC 2+. * The primary breast tumour measures > 20 mm by ultrasound and/or mammogram (clinical stage cT2-4). In the case of a multifical tumour (defined as the presence of two or more foci of cancer within the same breas ....
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Key Exclusion Criteria

* Prior incisional biopsy or excision of primary breast tumour. * Patients with an occult breast primary tumour or primary breast tumour that is not radiologically measurable. * Sentinel lymph node biopsy or axillary node removal prior to neoadjuvant therapy. Ultrasound-guided FNA cytology and/or core biopsy of suspicious axillary nodes is recommended at baseline. * Patients with grade 1 tumours. * Patients with bilateral breast cancer. * Multicentric breast cancer (the presence of more than one ....
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Can healthy volunteers participate?




Sample Size    134

Min. age    18 Years

Max. age    0 No limit

Sex    Females

Condition category    Grade 2/3 ER-positive, HER2-negative Invasive Breast Cancer > 20 mm

Condition code    Cancer


Intervention code Treatment: Drugs

Standard neoadjuvant chemotherapy plus aromatase inhibitor endocrine therapy (letrozole). Pre- and perimenopausal women will also receive goserelin. Participants randomised to the experimental chemo-endocrine arm will receive neoadjuvant endocrine therapy as follows: * Postmenopausal participants randomised to experimental arm: - Administration of oral letrozole 2.5 mg daily will commence as soon as feasible following randomisation, prior to initiation of chemotherapy and continue after completi ....
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Control group Active

Standard neoadjuvant chemotherapy: This will be an anthracycline and taxane containing regimen of 18-24 weeks duration. For sequential regimens, order of the taxane and anthracycline is at the sites’ discretion. Examples include: AC (or FEC) x 4 - weekly paclitaxel x 8-12 (or reverse sequence) AC (or FEC) x 4 - docetaxel x 4 (or reverse sequence) FEC X 3 - docetaxel x 3 (or reverse sequence)


Outcome: Rate of downstaging of invasive cancer to pathologic stage 0 or 1A (ypT0-1 ypN0 i.e. tumour <=20 mm and node negative). The ypT is measured as the largest single focus of invasive tumour
Timepoint: At the time of surgery

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

Anonymised Individual Patient Data (IPD) collected during the trial. The specific IPD to be shared (e.g. all data, published data, data of primary outcomes) will be as per the submitted research proposal and as assessed as appropriate by BCT.

When will data be available?

Data will be made available for request after publication of the main/final study results; no end date. Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines.

Available to whom?

Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Refer to the BCT Data Sharing Guidelines

Available for what types of analyses?

To achieve the aims in the approved proposal.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see