Trial of Perioperative Endocrine Therapy - Individualising Care (POETIC)
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|ClinicalTrials.gov Identifier: NCT02338310|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2015
Last Update Posted : February 17, 2020
To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI) followed by standard adjuvant therapy improves outcome compared with standard adjuvant therapy alone in postmenopausal women with hormone receptor positive breast cancer.
To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC) in the excised cancer around 2 weeks after starting AI therapy will predict for time to recurrence (TTR) in the individual patient more effectively than the pre-treatment Ki67 value.
To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts for long-term outcome in postmenopausal women with hormone receptor positive breast cancer better than at diagnosis.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Aromatase Inhibitors||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4486 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2034|
No Intervention: No Aromatase Inhibitor
No aromatase inhibitor given around the time of surgery
Experimental: Aromatase Inhibitor
Aromatase Inhibitor given perioperatively for 4 weeks (two weeks before and two weeks after surgery) Choice of AI is according to centre policy and may be either anastrozole (1mg/day) or letrozole (2.5mg/day)
Drug: Aromatase Inhibitors
Choice of AI is according to centre policy; any brand can be used
- Time to recurrence [ Time Frame: 5 years post-randomisation ]Time to recurrence (TTR) is defined as time from randomisation to local, regional, or distant tumour recurrence or death from breast cancer without prior notification of relapse. Second primary cancers and intercurrent deaths will be treated as censoring events. Patients who are alive and disease free will be censored at the date last seen alive.
- Relapse free survival [ Time Frame: 5 years post-randomisation ]Second primary cancers and deaths from non-breast cancer causes in the absence of breast cancer relapse will be treated as censoring events.
- Time to local recurrence [ Time Frame: 5 years post-randomisation ]
- Time to distant recurrence [ Time Frame: 5 years post-randomisation ]
- Overall Survival [ Time Frame: 5 years post-randomisation ]
- Breast cancer free survival [ Time Frame: 5 years post-randomisation ]
- Proliferation rate (Ki67) [ Time Frame: At time of surgery (around 2 weeks post-randomisation) ]Comparison of the predictive value of Ki67 at surgery in the perioperative therapy and non perioperative therapy groups will be undertaken using Cox regression, comparing the estimates of the hazard ratios obtained in each treatment group.
- Gene expression profile [ Time Frame: At time of surgery (around 2 weeks post-randomisation) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338310
|Principal Investigator:||Ian Smith, Professor||Royal Marsden NHS Foundation Trust|