Pre-surgical aromatase inhibitor combined with non-steroidal anti inflammatory drug treatment in breast cancer

Randomised phase 2 trial of pre-surgical aromatase inhibitor, combined with non-steroidal anti inflammatory drug treatment or no additional treatment, in post-menopausal women with early stage operable breast cancer, to determine anti-proliferative response to aromatase inhibitor and effect of both agents on immune cell composition.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000507684

Acronym

SAND

Enrollment

Registered

2014-05-13

Start date

2014-12-04

Completion date

2016-12-04

Last updated

2025-09-08

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

Conditions

None listed

Brief summary

Previous work suggests that the presence of inflammation in post-menopausal breast cancer is associated with a poor response to aromatase inhibitor treatment. Here, an anti inflammatory drug aspirin is given with the aromatase inhibitor, and the breast cancer will be sampled before and after the treatment, given in the window of time between diagnosis and definitive surgery

Interventions

in window of time between diagnosis and surgery, post-menopausal women with ER positive breast cancer will be treated with an aromatase inhibitor alone, letrozole 2.5mg daily oral tablet, or with aspirin 200mg twice daily, oral tablet, in an anti inflammatory dose. Adherence will be monitored by twice weekly nurse review, and blood estradiol levels.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

ER positive, stage 1-2 breast cancer, post-menopausal, no prior therapy

Exclusion criteria

not post-menopausal, prior breast cancer, other illnesses,

Outcome results