NCT05878314

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P75+ for all trials

Timeline
108mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Apr 2023Apr 2035

Study Start

First participant enrolled

April 25, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2035

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

May 4, 2023

Last Update Submit

February 9, 2026

Conditions

Hormone Receptor Positive HER-2 Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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).

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

Secondary Outcomes (1)

  • 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.

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

Study Arms (3)

Group A: Tamoxifen

Patients with early HR+/HER2- Breast cancer receiving Tamoxifen

Group B: Aromatase Inhibitor (+GnRH if premenopausal)

Patients with early HR+/HER2- Breast cancer receiving Aromatase Inhibitor (+GnRH if premenopausal)

Group C: Control group

no preoperative endocrine treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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)

You may qualify if:

  • 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
  • no lymph-node involvement by clinical evaluation and ultrasound (cN0)
  • not amendable to neoadjuvant chemotherapy
  • surgery or planned surgery at the Department for Women's Health, Tuebingen or Freiburg
  • planned preoperative endocrine treatment with Tamoxifen, Aromatase inhibitors, Goserelin or nothing for 2 - 4 weeks
  • written informed consent

You may not qualify if:

  • ER-negative and PR-negative
  • HER2-positive
  • bilateral breast cancer
  • preexisting cancer disease within the last 10 years
  • indication for neoadjuvant chemotherapy
  • any systemic therapy except Tamoxifen, Aromatase inhibitors, Goserelin before surgery
  • locally advanced, inoperable or metastatic breast cancer
  • pregnant or lactating patients
  • inadequate general condition (not fit for chemotherapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Women's Health

Tübingen, 72076, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

breast biopsy and blood test for sexual hormones (FSH, LH, Estrogen, Progesterone, Anti-Mullerian Hormone)

Study Officials

  • Dominik Dannehl, Dr.

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Dannehl, Dr.

CONTACT

07071 29 82211Dominik.Dannehl@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 26, 2023

Study Start

April 25, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2035

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)