Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer

ConditionHormone Receptor Positive HER-2 Negative Breast Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorUniversity Hospital Tuebingen

About this trial

PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors ± gonadotropin-releasing hormone (GnRH)-Analogues or nothing or no preoperative endocrine treatment as part of the clinical routine. The investigators moreover address the question whether PAM50 assessment in addition to Ki67 dynamics still impacts treatment recommendations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

women ≥ 18 years of age

histologically proven unilateral primary non-metastatic invasive breast cancer

Estrogen receptor (ER)-/ or Progesterone receptor (PR)- positive and HER2-negative

Ki67 from core biopsy is available

Disqualifiers

ER-negative and PR-negative

HER2-positive

bilateral breast cancer

preexisting cancer disease within the last 10 years

Trial population

252 premenopausal + 252 postmenopausal patients with early HR+/HER2 neg breast cancer receiving either * Tamoxifen (group A) * Aromatase inhibitor (+ GnRH if premenopausal) (group B) * nothing (group C) treatment during a window of opportunity of 2-3 weeks prior to surgery. Treatment will be assessed by investigators' choice and the three groups will be limited to 84 premenopausal/postmenopausal patients in each group)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

504 Participants

are grouped into 3 trial groups

Group A: Group A: Tamoxifen

Group B: Group B: Aromatase Inhibitor (+GnRH if premenopausal)

Group C: Group C: Control group

Trial outcomes

Primary outcomes

Influence of the menstrual cycle on initial Ki67 in premenopausal women

The number of Ki67 positive cell nuclei will be estimated for the entire core biopsy in a semiquantitative evaluation in steps of 10% by a board certified pathologist as part of the clinical routine workup. Ki67 assessment will be conducted on breast core biopsy (I) and surgical specimen (II).

Time frame

duration of therapy and follow-up data (10 years)

Secondary outcomes

Influence of preoperative anti-hormonal therapy, dynamics of the growth marker Ki67 (evaluation of positive cell nuclei by pathologist), and individual genetic risk (PAM50 gene test) on recommendations for adjuvant therapy.

1. breast biopsy, menstrual cycle assessment (questionnaire) and blood test for sexual hormones (follicle-stimulating hormone FSH, luteinizing hormone LH, Estrogen, Progesterone, Anti-Mullerian Hormone) 2. PAM50 assessment from initial core biopsy (prognostic gene signature assay) 3. determination of initial Ki67 (evaluation of positive cell nuclei by pathologist) 4. 2 weeks of endocrine treatment or not (depending on group) 5. preoperative menstrual cycle assessment (questionnaire) and blood test for sexual hormones (FSH, LH, Estrogen, Progesterone) in premenopausal patients 6. surgery and determination of posttherapeutic Ki67 (evaluation of positive cell nuclei by pathologist) 7. collection of clinical and pathological data 8. assessment of therapy recommendation without knowledge of the PAM50 (Questionnaire for the investigator) 9. assessment of therapy recommendation with knowledge of the PAM50 (Questionnaire for the investigator)

Time frame

duration of therapy and follow-up data (10 years)

Sponsors and contacts

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University Hospital Tuebingen

Lead sponsor

University Hospital Ulm

Collaborator

University Hospital Freiburg