Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting

Real-world study on breast cancer recurrence after CDK4/6 inhibitor treatment

NCT: NCT07180693 · Status: RECRUITING · Phase: N/A · Sponsor: European Institute of Oncology · Started: 2025-09-29 · Est. Completion: 2030-08-01

Plain English Summary

Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: is a Not Applicable clinical trial sponsored by European Institute of Oncology studying Adjuvant Therapy, CDK4/6 Inhibitor. This study looks at how well breast cancer patients do after taking specific drugs (ribociclib or abemaciclib) along with hormone therapy to prevent cancer from coming back. It's for patients with early-stage, hormone-receptor-positive, HER2-negative breast cancer who are at high risk of their cancer returning. Participation involves providing medical information and potentially having your treatment data collected over time. There are no direct alternatives being tested in this study; it observes real-world treatment outcomes. The trial aims to enroll 750 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are male or female, 18 or older, and have early-stage breast cancer that is HR+ and HER2-. You must be starting or have recently started treatment with ribociclib or abemaciclib combined with hormone therapy since January 1, 2021. You cannot join if you are currently in another breast cancer drug trial or have received CDK4/6 inhibitors as part of a trial. Individuals with a history of other cancers (except certain types) or breast cancer more than 5 years ago may be excluded. This trial is studying Adjuvant Therapy, CDK4/6 Inhibitor, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how long patients live without their cancer returning or spreading, which means it tracks how long the treatment is successful in keeping the cancer at bay. The specific primary outcome measures are: Invasive-disease free survival (IDFS) (3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it will provide real-world data on how effective and safe certain breast cancer treatments are when used to prevent recurrence, filling a gap in understanding beyond co This research targets Adjuvant Therapy, CDK4/6 Inhibitor, where improved treatment options are needed.

Investor Insight

This observational study signals a strong interest in understanding the real-world effectiveness of CDK4/6 inhibitors in the adjuvant setting, a growing market for breast cancer prevention, with a hig The large enrollment target of 750 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if this study is a good fit for you and what specific data will be collected. Your day-to-day involvement will likely be minimal, focusing on your regular medical appointments and treatment as prescribed. Be prepared to share your medical history and treatment details for the study's analysis. This trial is currently recruiting participants. The trial is being conducted at 18 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Frequently Asked Questions

What is clinical trial NCT07180693?

NCT07180693 is a Not Applicable OBSERVATIONAL study titled "Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:." It is currently recruiting and is sponsored by European Institute of Oncology. The trial targets enrollment of 750 participants.

What conditions does NCT07180693 study?

This trial investigates treatments for Adjuvant Therapy, CDK4/6 Inhibitor. The primary condition under study is Adjuvant Therapy.

What does Not Applicable mean for NCT07180693?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07180693?

This trial is currently "Recruiting." It started on 2025-09-29. The estimated completion date is 2030-08-01.

Who is sponsoring NCT07180693?

NCT07180693 is sponsored by European Institute of Oncology. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07180693?

The trial aims to enroll 750 participants. The trial is currently recruiting and accepting new participants.

How is NCT07180693 designed?

This is a observational study.

What are the primary outcomes being measured in NCT07180693?

The primary outcome measures are: Invasive-disease free survival (IDFS) (3 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07180693 being conducted?

This trial is being conducted at 18 sites, including Bergamo, Italy; Brescia, Italy; Brindisi, Italy; Crema, Italy and 14 more sites (Italy).

Where can I find official information about NCT07180693?

The official record for NCT07180693 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07180693. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07180693 testing in simple terms?

This study looks at how well breast cancer patients do after taking specific drugs (ribociclib or abemaciclib) along with hormone therapy to prevent cancer from coming back. It's for patients with early-stage, hormone-receptor-positive, HER2-negative breast cancer who are at high risk of their cancer returning.

Why is this trial significant?

This trial is important because it will provide real-world data on how effective and safe certain breast cancer treatments are when used to prevent recurrence, filling a gap in understanding beyond co

What are the potential risks of participating in NCT07180693?

The main risks are related to the known side effects of CDK4/6 inhibitors and hormone therapy, which can include low blood counts, fatigue, nausea, and diarrhea. There's a risk that the cancer could still return despite treatment, as this study is observing real-world outcomes. Data privacy and security are important considerations when participating in any study. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07180693?

Ask your doctor if this study is a good fit for you and what specific data will be collected. Your day-to-day involvement will likely be minimal, focusing on your regular medical appointments and treatment as prescribed. Be prepared to share your medical history and treatment details for the study's analysis. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07180693 signal from an investment perspective?

This observational study signals a strong interest in understanding the real-world effectiveness of CDK4/6 inhibitors in the adjuvant setting, a growing market for breast cancer prevention, with a hig This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves providing medical information and potentially having your treatment data collected over time. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.