Hormone Receptor Positive HER-2 Negative Breast Cancer Clinical Trial
Official title:
Impact of Preoperative Endocrine Therapy, Menstrual Cycle, PAM50 Assessment and Ki67 Dynamics on Adjuvant Treatment Decisions in Hormone Receptor-positive and HER2-negative Patients With Early Breast Cancer
NCT number | NCT05878314 |
Other study ID # | BZ_PEAK |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 25, 2023 |
Est. completion date | April 2035 |
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.
Status | Recruiting |
Enrollment | 504 |
Est. completion date | April 2035 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Women's Health | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | University Hospital Freiburg, University Hospital Ulm |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 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) |
duration of therapy and follow-up data (10 years) |
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