JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme

Rekrutierend

NCT-Nummer:
NCT05878314

Studienbeginn:
April 2023

Letztes Update:
05.06.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
University Hospital Ulm, University Hospital Freiburg,

Studienleiter

Dominik Dannehl, Dr.
Principal Investigator
University Hospital Tuebingen

Kontakt

Dominik Dannehl, Dr.
Kontakt:
Phone: 07071 29 82211
E-Mail: Dominik.Dannehl@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Women's Health
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Dominik Dannehl, Dr.
Phone: 07071 29 82211
E-Mail: Dominik.Dannehl@med.uni-tuebingen.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Background of the study Chemotherapy and anti-hormonal therapies improve the chances of cure

for patients with early-stage hormone receptor (HR)-positive/HER2-negative breast cancer.

However, only a few patients benefit from chemotherapy, as classical tumor characteristics

such as grading, tumor size, and lymph node involvement in the armpit have a prognostic value

but do not allow predictions about the effectiveness of chemotherapy. New treatment concepts,

such as gene expression tests and preoperative endocrine therapy, aim to identify patients

with a high risk of recurrence and provide them with optimized treatment. Additionally,

initial study results indicate that a woman's menstrual cycle could influence the tumor's

growth rate. These hints need to be investigated in larger studies to understand how the

growth rate of a tumor in different phases of the menstrual cycle can be interpreted.

Purpose of the study The main objective of the PEAK study is to investigate to what extent

the menstrual cycle phase influences the tumor growth rate (biomarker Ki67). To make a

scientifically sound statement, the growth rate of the tumor in postmenopausal patients must

also be examined. In addition, the impact of preoperative anti-hormonal therapy, the dynamics

of the growth marker Ki67, and the individual genetic risk (PAM50 gene test) on

recommendations for adjuvant therapy in clinical routine should be evaluated. Furthermore,

the influence of the aforementioned markers on established clinical-pathological risk factors

and the spread of tumor cells should be assessed.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

Exclusion Criteria:

- ER-negative and PR-negative

- HER2-positive

- bilateral breast cancer

- preexisting cancer disease within the last 10 years

- preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or

contralateral breast cancer is not regarded as an exclusion criteria)

- any systemic breast cancer therapy before inclusion into the trial

- 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)

- hormonal contraception within 6 months before inclusion

Studien-Rationale

Primary outcome:

1. Influence of the menstrual cycle on initial Ki67 in premenopausal women (Time Frame - duration of therapy and follow-up data (10 years)):
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).

Secondary outcome:

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. (Time Frame - duration of therapy and follow-up data (10 years)):
breast biopsy, menstrual cycle assessment (questionnaire) and blood test for sexual hormones (follicle-stimulating hormone FSH, luteinizing hormone LH, Estrogen, Progesterone, Anti-Mullerian Hormone) PAM50 assessment from initial core biopsy (prognostic gene signature assay) determination of initial Ki67 (evaluation of positive cell nuclei by pathologist) 2 weeks of endocrine treatment or not (depending on group) preoperative menstrual cycle assessment (questionnaire) and blood test for sexual hormones (FSH, LH, Estrogen, Progesterone) in premenopausal patients surgery and determination of posttherapeutic Ki67 (evaluation of positive cell nuclei by pathologist) collection of clinical and pathological data assessment of therapy recommendation without knowledge of the PAM50 (Questionnaire for the investigator) assessment of therapy recommendation with knowledge of the PAM50 (Questionnaire for the investigator)

Studien-Arme

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

Quelle: ClinicalTrials.gov

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