Early Breast CancerGIM 23- POSTERNCT05730647
Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
An observational study of Early Breast Cancer, run by Consorzio Oncotech at 40 sites in Italy.
Trial summary
This will be a prospective, multicenter, observational study. The primary objective is to record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen, tamoxifen + LhRh, aromatase inhibitors + LhRh) in premenopausal patients with estrogen-receptor positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Breast Cancer
- What is being tested?
- None intervention (observational study)
- How many people
- 600 participants
- Where
- 40 sitesItaly
- Study dates
- 24 Oct 2019to 31 Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery.
Who may be able to join
- - Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery
- - Age >18 years
- - No previous hormonal treatment
- - Written informed consent
Who cannot join
- 1- Patient's inability to provide written informed consent 2 - Stage IV disease
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Italy40 sites
Centro di Riferimento Oncologico- IRCCS
Aviano
A.O. Consorziale Policlinico di Bari
Bari
IRCCS Istituto Oncologico di Bari
Bari
Osp. Papa Giovanni XXIII
Bergamo
Presidio Ospedaliero "Antonio Perrino" ASL Brindisi
Brindisi
Università degli Studi "G.d'Annunzio" Chieti-Pescara
Chieti
ASST Lariana - Ospedale S. Anna
Como
Azienda Ospedaliera S. Croce e Carle
Cuneo
Azienda Ospedaliera Universitaria Careggi
Florence
I.R.C.C.S. A.O.U San Martino - IST
Genova
Ospedale Civile di Guastalla
Guastalla
Ospedale F.Renzetti di Lanciano
Lanciano
Ospedale S.M. Goretti
Latina
P.O. Vito Fazzi
Lecce
A.O. Ospedale Civile di Legnano
Legnano
AUSL Toscana Nord Ovest- Osp. Versilia
Lido di Camaiore
A.O.Papardo
Messina
A.O.U Policlinico di Modena
Modena
A.O.R.N. "A. Cardarelli"
Naples
AOU Federico II
Naples
Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi
Naples
Istituto Nazionale dei Tumori - Fondazione G. Pascale
Naples
Istituto Oncologico Veneto IRCCS
Padova
A. O. U. Pisana - Ospedale S. Chiara
Pisa
A.O.R. San Carlo
Potenza
Ospedale di Prato
Prato
Ospedale di Macerata
Province of Macerata
AUSL della Romagna- P.O. di Ravenna, Lugo e Faenza
Ravenna
IRCCS Arcispedale S.Maria Nuova
Reggio Emilia
Fondazione Policlinico Gemelli
Roma
Istituto Nazionale Tumori Regina Elena
Roma
Ospedale San Camillo Forlanini
Roma
Policlinico Universitario Campus Biomedico
Roma
Istituto Clinico Humanitas Irccs
Rozzano
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo
Ospedale San Vincenzo
Taormina
Presidio Ospedaliero Martini - ASL TO1
Torino
Ospedale Santa Chiara
Trento
Azienda Ospedaliera Universitaria SM Misericordia
Udine
Ospedale San Pio da Pietrelcina
Vasto
About this study
This will be a prospective, multicenter, observational study. The primary objective is to record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen, tamoxifen + LhRh, aromatase inhibitors + LhRh) in premenopausal patients with estrogen-receptor positive breast cancer.
The secondary objective is to correlate adjuvant hormone therapy choices with biological characteristics of the tumor (T size, lymph node status, grade, receptor level, Ki67, HER2 status) and patient characteristics (age, prior chemotherapy treatment).
- Conditions
- Early Breast Cancer
- Being tested
- None intervention (observational study)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None intervention (observational study)Other
None intervention (observational study)
What is being measured
The primary outcome is the main question the study is designed to answer.
To record the choice, in clinical practice, of adjuvant hormone therapy.
Patients will be divided in groups according to type of adjuvant hormone therapy received:
- tamoxifen
- tamoxifen + LhRh
- aromatase inhibitor + LhRh Differences between groups will be evaluated with Chi-square test and Mann-Whitney test.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start24 Oct 2019
- Primary completion1 Aug 2022
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorzio Oncotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730647
- Sponsor's protocol ID
- GIM23-POSTER
- Acronym
- GIM 23- POSTER
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Adjuvant Hormone Treatment in Estrogen-receptor Positive Premenopausal Early Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05730647
- Acronym / sponsor ID
- GIM 23- POSTER / GIM23-POSTER
- Conditions
- Early Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Consorzio OncotechUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 16 Feb 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 will be a prospective, multicenter, observational study. The primary objective is to record the choice, in clinical practice, of adjuvant hormone therapy (tamoxifen, tamoxifen + LhRh, aromatase inhibitors + LhRh) in premenopausal patients with estrogen-receptor positive breast cancer.
The secondary objective is to correlate adjuvant hormone therapy choices with biological characteristics of the tumor (T size, lymph node status, grade, receptor level, Ki67, HER2 status) and patient characteristics (age, prior chemotherapy treatment).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery.
Key inclusion criteria (4 listed)
- - Premenopausal patients candidate to start adjuvant hormone therapy after breast cancer surgery
- - Age >18 years
- - No previous hormonal treatment
- - Written informed consent
Key exclusion criteria (1 listed)
- 1- Patient's inability to provide written informed consent 2 - Stage IV disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None intervention (observational study)None intervention (observational study) | Other | – |
Primary outcome
To record the choice, in clinical practice, of adjuvant hormone therapy.
Time frame: 21 months
Patients will be divided in groups according to type of adjuvant hormone therapy received: 1. tamoxifen 2. tamoxifen + LhRh 3. aromatase inhibitor + LhRh Differences between groups will be evaluated with Chi-square test and Mann-Whitney test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Breast Cancer, run by Consorzio Oncotech at 40 sites in Italy.
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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To record the choice, in clinical practice, of adjuvant hormone therapy. (time frame: 21 months). 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 16 Feb 2023.