Breast CancerCLEAR-BNCT05870813
CLEAR-B: Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer
An observational study of Breast Cancer and HER2-negative Breast Cancer, run by Institut fuer Frauengesundheit at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 10 Mar 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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
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- 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
Who cannot join
- Patients with a low recurrence risk (see inclusion criteria for definition)
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Gynecology and Obstetrics, Erlangen University Hospital
Erlangen, 91054
Peter A. Fasching, MD, +49 9131 8543470, peter.fasching.studien@uk-erlangen.de
About this study
Official title: Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer (CLEAR-B)
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.
Read the detailed description
The treatment landscape concerning the adjuvant endocrine therapy in premenopausal patients with early-stage hormone receptor positive (HRpos) breast cancer is quite heterogeneous and therapy recommendations can vary. Tamoxifen (TAM) is a common treatment option that does not require OFS, but research suggests that adding OFS to tamoxifen may improve outcomes. Aromatase inhibitors (AI) are another option, but they can only be used with OFS for premenopausal patients. Studies have shown that AI + OFS improves disease-free survival compared to TAM + OFS, but it may lead to additional side effects such as osteopenia and bone fractures.
The CLEAR-B study aims to provide a detailed description of the therapy landscape in this therapeutic setting, including recurrence rates and overall survival with AI compared to TAM, as well as a comparison of the chosen therapies within prognostic subgroups.
CLEAR-B is a retrospective cohort study, collecting data of premenopausal patients who were diagnosed with early-stage breast cancer between January 2016 and June 2019 in a certified breast cancer center. These patients had an intermediate or high risk of cancer recurrence, as defined by (neo)adjuvant chemotherapy, and/or pT≥2cm at the timepoint of definitive surgery and/or at least one positive lymph node at the time of definite surgery (pN+).
The primary objective is to compare the invasive disease-free survival (iDFS) of patients who were treated with AI + OFS vs. those who were treated with TAM ± OFS. Additionally, the study will compare distant disease-free survival (DDFS) and overall survival (OS) between the two groups and perform subgroup analyses according to risk stratification (stage II and III). This study will be conducted at around 75 certified breast cancer centers and will enroll up to 3000 patients.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AI+OFS | adjuvant treatment with aromatase inhibitor + OFS (ovarian function suppression) | |
| TAM | Patients started the adjuvant treatment with Tamoxifen ± OFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Secondary outcomes (14)
Comparison of DDFS
To analyze the non-inferiority of the Cohort AI+OFS compared with the Cohort TAM with regard to distant disease-free survival (DDFS). DDFS will be assessed as time to event. Events for DDFS include distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause.
Measured: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of OS
To analyze the non-inferiority of the Cohort AI+OFS compared with the Cohort TAM with regard to overall survival (OS). In case non-inferiority is confirmed, the superiority of Cohort AI+OFS over Cohort TAM will be tested with regard to OS.
OS is defined as time from first start of adjuvant endocrine therapy until date of death due to any cause.
Measured: First start of adjuvant endocrine therapy until date of death up to 5 years
Comparison of iDFS in Cohort TAM
To compare patients within the Cohort TAM who were treated with OFS and those who were not treated with OFS. 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)
Measured: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of DDFS in Cohort TAM
To compare patients within the Cohort TAM who were treated with OFS and those who were not treated with OFS. DDFS will be assessed as time to event. Events for DDFS include distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause.
Measured: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of OS in Cohort TAM
To compare patients within the Cohort TAM who were treated with OFS and those who were not treated with OFS. OS is defined as time from first start of adjuvant endocrine therapy until date of death due to any cause.
Measured: First start of adjuvant endocrine therapy until date of death up to 5 years
Comparison of iDFS (TAM+OFS and AI+OFS)
To compare patients of Cohort AI+OFS with patients in Cohort TAM, who were treated with OFS 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)
Measured: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of DDFS (TAM+OFS and AI+OFS)
To compare patients of Cohort AI+OFS with patients in Cohort TAM, who were treated with OFS with regard to DDFS. DDFS will be assessed as time to event. Events for DDFS include distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause.
Measured: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of OS (TAM+OFS and AI+OFS)
To compare patients of Cohort AI+OFS with patients in Cohort TAM who were treated with OFS.
OS is defined as time from first start of adjuvant endocrine therapy until date of death due to any cause.
Measured: First start of adjuvant endocrine therapy until date of death up to 5 years
Comparison of iDFS (TAM-OFS and AI+OFS)
To compare patients of Cohort AI+OFS with patients in Cohort TAM, who were not treated with OFS 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)
Measured: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of DDFS (TAM-OFS and AI+OFS)
To compare patients of Cohort AI+OFS with patients in Cohort TAM, who were not treated with OFS with regard to DDFS.
DDFS will be assessed as time to event. Events for DDFS include distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause.
Measured: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of OS (TAM-OFS and AI+OFS)
To compare patients of Cohort AI+OFS with patients in Cohort TAM who were not treated with OFS.
OS is defined as time from first start of adjuvant endocrine therapy until date of death due to any cause.
Measured: First start of adjuvant endocrine therapy until date of death up to 5 years
Influence of disease stage
To conduct multivariate analyses to estimate the influence of disease stage on prognosis.
Measured: Baseline until onset of disease progression or death up to 5 years
Risk Factors
To conduct subgroup analyses for the survival outcomes (iDFS, DDFS, OS) according to risk stratification (stage II and stage III)
Measured: Baseline until onset of disease progression or death up to 5 years
NATALEE Comparison
To compare patients who are matching the inclusion and exclusion criteria of the pivotal study NATALEE and who were treated in Cohort AI+OFS with patients matching the NATALEE population and who were treated in Cohort TAM.
Measured: Baseline until onset of disease progression or death up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start10 Mar 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Collaborators
- AGO Breast Study Group e.V., Novartis Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870813
- Sponsor's protocol ID
- IFG-02-2022
- Other IDs
- AGOB-059
- Acronym
- CLEAR-B
- Status last verified
- May 2023
- First submitted
- 14 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Landscape - Early Adjuvant Retrospective Registry - Breast Cancer (CLEAR-B)
- ClinicalTrials.gov ID
- NCT05870813
- Acronym / sponsor ID
- CLEAR-B / IFG-02-2022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Institut fuer FrauengesundheitUniversity, hospital or other
- Collaborators
- AGO Breast Study Group e.V., Novartis Pharmaceuticals
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The treatment landscape concerning the adjuvant endocrine therapy in premenopausal patients with early-stage hormone receptor positive (HRpos) breast cancer is quite heterogeneous and therapy recommendations can vary. Tamoxifen (TAM) is a common treatment option that does not require OFS, but research suggests that adding OFS to tamoxifen may improve outcomes. Aromatase inhibitors (AI) are another option, but they can only be used with OFS for premenopausal patients. Studies have shown that AI + OFS improves disease-free survival compared to TAM + OFS, but it may lead to additional side effects such as osteopenia and bone fractures.
The CLEAR-B study aims to provide a detailed description of the therapy landscape in this therapeutic setting, including recurrence rates and overall survival with AI compared to TAM, as well as a comparison of the chosen therapies within prognostic subgroups.
CLEAR-B is a retrospective cohort study, collecting data of premenopausal patients who were diagnosed with early-stage breast cancer between January 2016 and June 2019 in a certified breast cancer center. These patients had an intermediate or high risk of cancer recurrence, as defined by (neo)adjuvant chemotherapy, and/or pT≥2cm at the timepoint of definitive surgery and/or at least one positive lymph node at the time of definite surgery (pN+).
The primary objective is to compare the invasive disease-free survival (iDFS) of patients who were treated with AI + OFS vs. those who were treated with TAM ± OFS. Additionally, the study will compare distant disease-free survival (DDFS) and overall survival (OS) between the two groups and perform subgroup analyses according to risk stratification (stage II and III). This study will be conducted at around 75 certified breast cancer centers and will enroll up to 3000 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI+OFS | – | –adjuvant treatment with aromatase inhibitor + OFS (ovarian function suppression) |
| TAM | – | –Patients started the adjuvant treatment with Tamoxifen ± OFS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (12 listed)
- 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
- Patients with an intermediate or high-risk early-stage breast cancer defined as: At least one of the following must be fulfilled
- 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
Key exclusion criteria (8 listed)
- Patients with a low recurrence risk (see inclusion criteria for definition)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
iDFS
Time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
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)
Comparison of iDFS
Time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
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)
14 secondary outcomes
Comparison of DDFS
Time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of OS
Time frame: First start of adjuvant endocrine therapy until date of death up to 5 years
Comparison of iDFS in Cohort TAM
Time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of DDFS in Cohort TAM
Time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of OS in Cohort TAM
Time frame: First start of adjuvant endocrine therapy until date of death up to 5 years
Comparison of iDFS (TAM+OFS and AI+OFS)
Time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of DDFS (TAM+OFS and AI+OFS)
Time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of OS (TAM+OFS and AI+OFS)
Time frame: First start of adjuvant endocrine therapy until date of death up to 5 years
Comparison of iDFS (TAM-OFS and AI+OFS)
Time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of DDFS (TAM-OFS and AI+OFS)
Time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years
Comparison of OS (TAM-OFS and AI+OFS)
Time frame: First start of adjuvant endocrine therapy until date of death up to 5 years
Influence of disease stage
Time frame: Baseline until onset of disease progression or death up to 5 years
Risk Factors
Time frame: Baseline until onset of disease progression or death up to 5 years
NATALEE Comparison
Time frame: Baseline until onset of disease progression or death up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and HER2-negative Breast Cancer, run by Institut fuer Frauengesundheit at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CLEAR Study Manager (+49 9131 91 88 0613, clear@ifg-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iDFS (time frame: First start of adjuvant endocrine therapy until date of the above mentioned events up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.