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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 : January 14, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2008
Estimated Primary Completion Date : April 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Other Names:
  • Anastrazole
  • Letrozole


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Time to local recurrence [ Time Frame: 5 years post-randomisation ]
  3. Time to distant recurrence [ Time Frame: 5 years post-randomisation ]
  4. Overall Survival [ Time Frame: 5 years post-randomisation ]
  5. Breast cancer free survival [ Time Frame: 5 years post-randomisation ]
  6. 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.

  7. Gene expression profile [ Time Frame: At time of surgery (around 2 weeks post-randomisation) ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Post menopausal women with core biopsy-proven hormone receptor positive invasive breast cancer. Postmenopausal is defined as a woman aged ≥50 years fulfilling any one of the following criteria:

    i) with amenorrhoea >12 months and an intact uterus; ii) has undergone a bilateral oophorectomy; iii) in women who have undergone a hysterectomy, then FSH levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged <55 years; or iv) in women who have been on HRT within the last 12 months and therefore not amenorrhoeic, FSH levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged <55 years.

  2. No evidence of metastatic spread by standard assessment according to local guidelines
  3. Standard adjuvant endocrine therapy indicated
  4. A palpable tumour of any size , or a tumour with an ultrasound size of at least 1.5cm
  5. WHO performance status of 0 or 1
  6. Written informed consent to participate in the trial and to donation of tissue (fresh tissue and surplus tissue from diagnostic procedures) and blood samples.

Exclusion Criteria:

  1. Locally advanced/inoperable breast cancer
  2. Evidence of metastatic disease
  3. Previous invasive breast cancer (surgically treated DCIS or LCIS allowed)
  4. Current bilateral breast cancer
  5. Multiple unilateral tumours with different ER/PgR/HER2 status, grade or type (e.g. ductal vs lobular) i.e. anything that suggests two or more different cancers. Multifocal disease with homogenous ER/PgR/HER2 status, grade and type is allowed if at least one lesion is palpable or at least 1.5cm on ultrasound; the largest lesion should be used for sample collection and CRF completion.
  6. Concurrent use (defined as use within 4 weeks prior to diagnostic tissue sample being taken) of HRT or any other oestrogen-containing medication (including vaginal oestrogens)
  7. Previous use of oestrogen implants at ANY time
  8. Prior endocrine therapy or chemotherapy for breast cancer
  9. Any invasive malignancy diagnosed within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
  10. Any severe co-incident medical disease, inability to give informed consent or unavailability for follow-up
  11. Treatment with an unlicensed or investigational drug within 4 weeks before randomisation
  12. Current, continuous, long term systemic steroid usage
Contacts and Locations

Information from the National Library of Medicine

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


  Show 128 Study Locations
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Principal Investigator: Ian Smith, Professor Royal Marsden NHS Foundation Trust
More Information

Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02338310     History of Changes
Other Study ID Numbers: ICR-CTSU/2007/10015
2007-003877-21 ( EudraCT Number )
CRUK/07/015 ( Other Grant/Funding Number: Cancer Research UK )
08/H1102/37 ( Other Identifier: Main Research Ethics Committee Number )
63882543 ( Registry Identifier: ISRCTN )
CCR 2973 ( Other Identifier: Sponsor )
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Letrozole
Aromatase Inhibitors
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs