Adjuvant TherapyBREAKERNCT07180693
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
An observational study of Adjuvant Therapy and CDK4/6 Inhibitor, run by European Institute of Oncology at 18 sites in Italy.
Trial summary
This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+/HER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adjuvant Therapy, CDK4/6 Inhibitor
- How many people
- 750 participants
- Where
- 18 sitesItaly
- Study dates
- 29 Sep 2025to 1 Aug 2030
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with HR+/HER2- breast cancer who have received medical treatment in the neoadjuvant or adjuvant setting (chemotherapy, radiotherapy and hormonotherapy) and who have received or are scheduled to initiate adjuvant treatment with CDK4/6 inhibitors (abemaciclib or ribociclib) in combination with ET in the adjuvant setting.
Who may be able to join
- Female (regardless of menopausal status) or male ≥18 years of age;
- The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4/6 inhibitors (abemaciclib or ribociclib);
- ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO/CAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO/CAP recommendations;
- Patients who are initiating or have initiated adjuvant treatment with a CDK4/6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1, 2021.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- Consent to data treatment according to the local regulation.
Who cannot join
- Current participation in any other HR+/HER2- EBC study with any investigational products;
- Patients who have already received adjuvant treatment with a CDK4/6 inhibitor as part of a clinical trial;
- Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study;
- Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago;
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
Italy18 sites, 18 recruiting
- Not yet recruiting
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
Rita De Sanctis, MD, +39 035 267111, rdesanctis@asst-pg23.it
Rita De Sanctis, MD
- Recruiting
ASST Spedali Civili di Brescia
Brescia, Italy, 25123
Marta Laganà, MD, +39 030 3995410, marta.lagana@unibs.it
Marta Laganà, MD
- Not yet recruiting
P.O. Antonio Perrino - ASL Brindisi
Brindisi, Italy, 72100
Laura Orlando, MD, +39 0831 537111, laura.orlando68@gmail.com
Laura Orlando, MD
- Recruiting
ASST Ospedale Maggiore di Crema
Crema, Italy, 26013
Gianluca Tomasello, MD, +39 0373280730, Gianluca.tomasello@asst-crema.it
Gianluca Tomasello, MD
- Not yet recruiting
ASST Lecco - PO Alessandro Manzoni
Lecco, Italy, 23900
Alessandra Crippa, MD, +39 03 41253000, a.crippa@asst-lecco.it
Alessandra Crippa, MD
- Not yet recruiting
Asst Ovest Milanese
Legnano, Italy, 20025
Concetta Arcanà, MD, +39 02 26433169, concetta.arcana@asst-ovestmi.it
Concetta Arcanà, MD
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Luca Licata, MD, +39 02 26433169, licata.luca@hsr.it
Luca Licata, MD
- Not yet recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy, 20133
Francesca Ligorio, MD, +39 0223903808, francesca.ligorio@istitutotumori.mi.it
Francesca Ligorio, MD
- Recruiting
European Institute of Oncology
Milan, Italy, 20141
Nadia Bianco, MD, +39 02 94371977, nadia.bianco@ieo.it
Nadia Bianco, MD
- Recruiting
PO Luigi Sacco - ASST Fatebenefratelli Sacco
Milan, Italy, 20157
Maria Silvia Cona, MD, +39 02 39042493, silvia.cona@asst-fbf-sacco.it
Maria Silvia Cona, MD
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy, 41125
Angela Toss, MD, +39 059 4222230, angelatoss@unimore.it
Angela Toss, MD
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Francesca Riva, MD, +39 039 2339575, francesca.riva@irccs-sangerardo.it
Francesca Riva, MD
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy, 80131
Vincenzo Di Lauro, MD, +39 081 5903111, vincenzo.dilauro@istitutotumori.na.it
Vincenzo Di Lauro, MD
- Recruiting
ICS Maugeri IRCCS
Pavia, Italy, 27100
Barbara Tagliaferri, MD, +39 03825921, barbara.tagliaferri@icsmaugeri.it
Barbara Tagliaferri, MD
- Recruiting
Policlinico San Matteo
Pavia, Italy, 27100
Gianpiero Rizzo, MD, +39 0382502094, g.rizzo@smatteo.pv.it
Gianpiero Rizzo, MD
- Recruiting
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy, 42122
Laura Cortesi, MD, +39 0522335111, cortesilaura67@gmail.com
Laura Cortesi, MD
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Luisa Carbognin, MD, +39 06 30154953, luisa.carbognin@policlinicogemelli.it
Luisa Carbognin, MD
- Recruiting
Ospedale Isola Tiberina - Gemelli Isola
Roma, Italy, 00186
Anna Cardillo, MD, +39 066837697, anna.cardillo@fbf-isola.it
Anna Cardillo, MD
About this study
Official title: Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting
This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+/HER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.
Read the detailed description
The study will also evaluate clinico-pathologic characteristics, patterns of recurrence, therapeutic choices and outcomes of the subgroup of patients relapsed during or within 12 months after adjuvant therapy with CDK4/6 inhibitors in combination with ET.
- Conditions
- Adjuvant Therapy, CDK4/6 Inhibitor
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 |
|---|---|---|
| Group 1 | Patients undergoing treatment with CDK4/6 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive-disease free survival (IDFS)
Invasive disease-free survival (IDFS) will be defined as the time from surgery to invasive loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death from any cause, whichever occurs first.
Measured: 3 years
Secondary outcomes (3)
Distant relapse-free survival (DRFS)
DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first.
Measured: 5 years
progression-free survival (PFS)
PFS will be defined as the time from the disease recurrence to the date of documented disease progression or death from any cause, whichever occurs first.
Measured: 5 years
Overall survival (OS)
OS will be defined as the time from surgery to death from any cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start29 Sep 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjuvant TherapyStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Bianco, MD, Study chair, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180693
- Sponsor's protocol ID
- UID 4879
- Acronym
- BREAKER
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2025
- Last updated
- 29 May 2026
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting
- ClinicalTrials.gov ID
- NCT07180693
- Acronym / sponsor ID
- BREAKER / UID 4879
- Conditions
- Adjuvant Therapy, CDK4/6 Inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 18 Sep 2025 (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 multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+/HER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.
Detailed description
The study will also evaluate clinico-pathologic characteristics, patterns of recurrence, therapeutic choices and outcomes of the subgroup of patients relapsed during or within 12 months after adjuvant therapy with CDK4/6 inhibitors in combination with ET.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients undergoing treatment with CDK4/6 inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with HR+/HER2- breast cancer who have received medical treatment in the neoadjuvant or adjuvant setting (chemotherapy, radiotherapy and hormonotherapy) and who have received or are scheduled to initiate adjuvant treatment with CDK4/6 inhibitors (abemaciclib or ribociclib) in combination with ET in the adjuvant setting.
Key inclusion criteria (6 listed)
- Female (regardless of menopausal status) or male ≥18 years of age;
- The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4/6 inhibitors (abemaciclib or ribociclib);
- ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO/CAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO/CAP recommendations;
- Patients who are initiating or have initiated adjuvant treatment with a CDK4/6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1, 2021.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
Key exclusion criteria (5 listed)
- Current participation in any other HR+/HER2- EBC study with any investigational products;
- Patients who have already received adjuvant treatment with a CDK4/6 inhibitor as part of a clinical trial;
- Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study;
- Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago;
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.
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
Invasive-disease free survival (IDFS)
Time frame: 3 years
Invasive disease-free survival (IDFS) will be defined as the time from surgery to invasive loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death from any cause, whichever occurs first.
3 secondary outcomes
Distant relapse-free survival (DRFS)
Time frame: 5 years
progression-free survival (PFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
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 29 May 2026.
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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.
Nadia Bianco, MD study chair
European Institute of Oncology
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adjuvant Therapy and CDK4/6 Inhibitor, run by European Institute of Oncology at 18 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Contact Nadia Bianco, MD (+39 02 94371977, nadia.bianco@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive-disease free survival (IDFS) (time frame: 3 years). 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 29 May 2026.