PreOperative Endocrine Therapy for Individualised Care With Abemaciclib (POETIC-A)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2028
  • participants needed
    2500
  • sponsor
    Institute of Cancer Research, United Kingdom
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Updated on 17 October 2022
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Summary

POETIC-A is a phase 3 trial which targets post-menopausal primary breast cancer patients with a high 5-year risk of relapse as determined by a high Ki67 after 2 weeks aromatase inhibitor therapy pre-surgery. Eligible patients will be randomised to standard adjuvant endocrine therapy alone or standard adjuvant endocrine therapy with a CDK4/6 inhibitor called abemaciclib.

Description

In women with hormone sensitive early breast cancer, taking a hormone therapy (also known as endocrine therapy) for at least five years after surgery is very effective at reducing the risk of the cancer returning. However, for some women their cancer may eventually become resistant to these drugs. POETIC-A Registration part will identify those who have a higher risk of developing resistance to standard endocrine therapy (ET). 5000 - 6000 women diagnosed with early stage breast cancer and have not yet had surgery to remove the cancer will enter the Registration stage from 80 centres. Study doctors will use aromatase inhibitors (AIs), a type of ET, to treat the cancer for 2 weeks before surgery. A sample will be taken from the cancer during surgery and the study laboratory will measure a biological marker called Ki67. If the level of Ki67 does not drop after 2 weeks of AI treatment, the patient is likely to be less sensitive to endocrine therapy, and the study doctor will explore additional treatments after surgery in the POETIC-A Treatment part. Everyone who agrees to join the Treatment stage (2500 patients) will be randomly put into one of the 2 treatment groups; Group1: ET only; or Group2: ET plus a new drug called abemaciclib. The first aim of the Treatment stage is to confirm whether abemaciclib given in combination with ET is more effective than giving ET alone in preventing the cancer coming back. The study laboratory will perform a second test on the cancer sample, called an AIR-CIS test. This test aims to find out if particular groups of patients based on their tumour biology are more suitable for treatment with abemaciclib. Patients in Group 2 will receive ET plus abemaciclib for 2 years. Patients in both groups will have regular study visits during this period.

Details
Condition Breast Cancer Female
Treatment Abemaciclib, Endocrine Therapy
Clinical Study IdentifierNCT04584853
SponsorInstitute of Cancer Research, United Kingdom
Last Modified on17 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patient previously consented and registered for screening component of POETIC A
Centrally confirmed Ki67 >/=8% following 2 weeks of AI
Aromatase Inhibitor Resistant-CDK4/6 Inhibitor Sensitive (AIR-CIS) signature has been
derived in the central laboratory and confirmed to ICR-CTSU
Patient must have undergone definitive surgery for the primary breast tumour with
clear radial margins as judged by the multidisciplinary team
Surgical staging of the axilla must have been undertaken by sentinel node biopsy
axillary sampling or dissection
The patient is able to swallow oral medications
Adjuvant chemotherapy, if prescribed, must have been completed prior to randomisation
and patients must have recovered (Common Terminology Criteria for Adverse Events
The patient intends to take adjuvant endocrine therapy for at least 5 years
version 5 [CTCAEv5] Grade </=1) from the acute effects of chemotherapy except for
residual alopecia or Grade 2 peripheral neuropathy prior to randomisation. A washout
period of a minimum of 28 days from day 1 of last cycle of treatment is required
Adjuvant radiotherapy, if prescribed, must have been completed prior to randomisation
and patients must have recovered (Grade </=1) from the acute effects of radiotherapy
A washout period of at least 14 days is required between end of radiotherapy and
randomisation
The patient should be randomised within 6 months of commencement of adjuvant endocrine
therapy
The patient has adequate organ function for all of the following criteria defined as
ANC >/= 1.5 × 109/L (G-CSF cannot be administered to meet this ANC eligibility
criterion) Platelets >/= 100 × 109/L Haemoglobin >/= 8g/dL (Blood transfusions cannot
be administered to meet this haemoglobin eligibility criterion) Total bilirubin </=
5 × ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and
direct bilirubin within normal limits are permitted.) ALT and AST </= 3 × ULN
The patient has given written informed consent prior to any study-specific procedures
(for the randomised intervention stage), willing to donate tissue from diagnostic
biopsy, and is willing and able to make herself available for the duration of the
study and to follow study schedule during treatment and follow-up and for the use of
routinely collected electronic health and related records

Exclusion Criteria

Patient has received prior CDK4/6 inhibitor
Any patient with a history of VTE (for example, DVT of the leg or arm and/or PE) will
be excluded. Patients with a history of venous catheter occlusion by thrombus that did
NOT surround the catheter, and the lumen could be made patent by appropriate measures
(for example, saline or thrombolytic agent), are not excluded
The patient has a serious/or uncontrolled pre-existing medical condition(s) that, in
the judgment of the investigator, would preclude participation in this study (such as
severe renal impairment, [for example, estimated creatinine clearance <30 mL/min]
interstitial lung disease, severe dyspnoea at rest or requiring oxygen therapy
history of major surgical resection involving the stomach or small bowel, or
pre-existing Crohn's disease or ulcerative colitis or a pre-existing chronic condition
resulting in baseline Grade 2 diarrhoea)
The patient has a personal history of any of the following conditions: syncope of
cardiovascular aetiology, ventricular arrhythmia of pathological origin (including
but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden
cardiac arrest. Exception: patients with controlled atrial fibrillation diagnosed more
than 30 days prior to randomisation are eligible
The patient has active systemic bacterial infections (requiring IV antibiotics at time
of initiating study treatment), systemic fungal infection or detectable viral
infection (such as known HIV positivity or with known active hepatitis B or C (e.g
hepatitis B surface antigen positive). Screening is not required for enrolment
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