CLEAR-B: Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer

NCT05870813 | Unknown

• 2 other identifiers: IFG-02-2022AGOB-059
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-interventional retrospective cohort study of premenopausal patients with HR+/HER2- breast cancer who are treated in the adjuvant setting with either Tamoxifen, Tamoxifen + Ovarial Function Suppression or Aromatase inhibitor + Ovarial Function Suppression.

Conditions

Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• iDFS

  The primary study aim is to show that aromatase inhibitor (AI) based treatments (AI arm) are not inferior to treatments based on tamoxifen (tamoxifen arm) in terms of invasive diseasefree survival (iDFS). iDFS will be assessed as time to event. Events for iDFS include: Invasive Ipsilateral Breast Tumor Recurrence (IBTR), Local/Regional Invasive Recurrence, Distant Recurrence, Death from BC, Death from Non-BC Cause, Death From unknown cause, Invasive Contralateral BC, Second Primary Invasive Cancer (non-breast)

  First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years

• Comparison of iDFS

  In case non-inferiority is confirmed, the superiority of Cohort AI+OFS over Cohort TAM will be tested with regard to iDFS. iDFS will be assessed as time to event. Events for iDFS include: Invasive Ipsilateral Breast Tumor Recurrence (IBTR), Local/Regional Invasive Recurrence, Distant Recurrence, Death from BC, Death from Non-BC Cause, Death From unknown cause, Invasive Contralateral BC, Second Primary Invasive Cancer (non-breast)

  First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years

Secondary Outcomes (14)

• Comparison of DDFS

  First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years

• Comparison of OS

  First start of adjuvant endocrine therapy until date of death up to 5 years

• Comparison of iDFS in Cohort TAM

  First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years

• Comparison of DDFS in Cohort TAM

  First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years

• Comparison of OS in Cohort TAM

  First start of adjuvant endocrine therapy until date of death up to 5 years

Other Outcomes (2)

• Therapy frequencies

  Baseline

• Adherence

  End of Treatment/ Treatment termination up to 5 years

Study Arms (2)

AI+OFS

adjuvant treatment with aromatase inhibitor + OFS (ovarian function suppression)

TAM

Patients started the adjuvant treatment with Tamoxifen ± OFS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal patients with early-stage breast cancer who have been diagnosed from January 2016 to June 2019 with an intermediate or high recurrence risk in a certified breast cancer center (DKG/DGS).

You may qualify if:

• Female patients with a first primary diagnosis of hormone receptor-positive, HER2- negative unilateral early breast cancer for whom an endocrine treatment is indicated
• Patients must be at least 18 years of age but not older than 60
• Premenopausal defined as all statements must be true
• No oophorectomy before the diagnosis of breast cancer
• Women with uterus: Regular, physiological menses at the timepoint of therapy decision for anti-endocrine treatment in the absence of contraceptives and hormonal treatment
• Women without uterus and remaining ovaries: premenopausal hormone levels must be documented at the time of therapy decision for anti-endocrine treatment
• Patients with an intermediate or high-risk early-stage breast cancer defined as: At least one of the following must be fulfilled
• (Neo)adjuvant chemotherapy
• pT≥2cm at the timepoint of definitive surgery
• at least one positive lymph node at the time of definite surgery (pN+)
• Patient must be previously registered in and must have been documented as part of the certification process for a certified breast cancer center according to the Deutsche Krebsgesellschaft/Deutsche Gesellschaft für Senologie
• Breast Cancer must have been diagnosed between Jan 2016 and Jun 2019

You may not qualify if:

• Locally advanced breast cancer or distant metastases at diagnosis
• Male biological sex
• Patients not treated in a certified breast cancer center
• Treatment with CDK4/6Previous diagnosis of invasive breast cancer or in situ breast cancer
• Concurrent invasive malignancy
• Bilateral breast cancer at the timepoint of diagnosis
• Previous diagnosis of invasive breast cancer or in situ breast cancer is not allowed

Sponsors & Collaborators

• Institut fuer Frauengesundheit: lead
• AGO Breast Study Group e.V.: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Department of Gynecology and Obstetrics, Erlangen University Hospital

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

CLEAR Study Manager

CONTACT

+49 9131 91 88 0613; clear@ifg-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 23, 2023
• Study Start: March 10, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

DE (1)