CancerREALNESSNCT06676436

Observational Study on the Treatment of Patients With Metastatic Breast Cancer

An observational study of Cancer, run by AstraZeneca at 4 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a descriptive, retrospective, observational study to generate Real-World Evidence (RWE). This study will evaluate the treatment patterns and outcomes with metastatic or unresectable hormone receptor-positive breast cancer in Brazil. No hypotheses will be tested. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cancer
How many people: 204 participants
Where: 4 sitesBrazil
Study dates: 30 Nov 2024to 31 Dec 2025
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: This study will consist of a convenience cohort; it will include 200 patients. Adult patients who had received treatment in the participant Brazilian centers, with mBC ER-positive (i.e. ER ≥ 1%) and HER2-negative (i.e. HER2 IHC 0, 1 or 2+ with negative ISH), and who had received any CDK4/6i as first-line treatment with any outcome (death, progressive disease, or drug interruption due to any cause) since January 2018 will be enrolled.

Who may be able to join

Patient or next of kin/legal representative willing and able to provide written informed consent according to the local regulations unless a waiver is granted by the local IRB/IEC/EC;
Adult female or male patients ≥18 years old;
Unresectable or metastatic breast cancer; Estrogen Receptor ≥ 1% at the moment first-line treatment was initiated, either in a biopsy immediately before starting treatment for metastatic disease or in the biopsy of initial breast cancer diagnosis if a new biopsy was not performed;
HER2-negative (IHC 0, 1+ or 2+/ISH negative) at the moment first-line treatment was initiated, either in a biopsy immediately before starting treatment for metastatic disease or in the biopsy of initial breast cancer diagnosis if a new biopsy was not performed;
Have received treatment with a CDK4/6i in the first-line treatment for unresectable or metastatic breast cancer;
Have discontinued permanently the treatment with CDK4/6 for any reason: progressed disease on first-line treatment, died during first-line treatment due to any cause, or interrupted treatment for any reason;
Patients with recurrent disease are not mandated to have a new biopsy at the time of recurrence

Who cannot join

Patients with recurrent disease with a primary tumor showing a different pattern of receptors (i.e. initial BC other than ER ≥ 1% and HER2 negative (IHC 0, 1+ or 2+/ISH negative);
Patients with a concomitant cancer at the time of the diagnosis of MBC HR-positive HER2-negative except for the non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HR-positive HER2-negative BC diagnosis;
Patients who at time of data collection for this study are participating or have participated in an interventional study that remains blinded.

Trial locations and contacts

4 sites in 1 country.

Brazil4 sites

Research Site
Fortaleza
Research Site
Porto Alegre
Research Site
Salvador
Research Site
São Paulo

Other trials in Brazil

About this study

Official title: Real World Outcomes and Treatment Patterns in Brazilian Patients With Hormone Receptor Positive / HER2-negative Unresectable or Metastatic Breast Cancer

Read the detailed description

This project aims to understand treatment patterns and outcomes in individuals with hormone receptor-positive [HR-positive will be defined as Estrogen Receptor (ER) ≥ 1%] and HER2-negative (HER2-Negative will be defined as IHC 0, 1+ and 2+/ISH-) unresectable or metastatic breast cancer (mBC) in Brazil.

Ten Brazilian centers will participate. This study will consist of a convenience cohort; will be included 200 patients. Adult patients who had received treatment in the participant Brazilian centers, with mBC ER-positive (i.e. ER ≥ 1%) and HER2-negative (i.e. HER2 IHC 0, 1 or 2+ with negative ISH), and who had received any CDK4/6i as first-line treatment with any outcome (death, progressive disease, or drug interruption due to any cause) since January 2018 will be enrolled. Data will be extracted from digital charts of Brazilian participating institutions. Patients who were treated with a CDK4/6i since January 2018 will be enrolled.

Conditions: Cancer
Keywords: Cancer, Breast
Medical subject headings: Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients by drug class and treatment line
The proportion of HR-positive/HER2-negative patients receiving each drug class in each line of treatment
Measured: through study completion, an average of 1 year"

Secondary outcomes (2)

Indicate demographic of these patients
Demographic profile: age, gender, ethnicity, family history of BC
Measured: through study completion, an average of 1 year"
Indicate pathological characteristics of these patients
Clinic-pathological profile: ECOG, staging, histological type, sites of metastasis, genetic alterations, early breast cancer treatments, comorbidities, menopausal status, description of HER2 testing
Measured: through study completion, an average of 1 year"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202431 Dec 2025

First posted6 Nov 2024
Study start30 Nov 2024
Primary completion31 Dec 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Retrospective
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06676436
Sponsor's protocol ID: D9673R00053
Acronym: REALNESS
Status last verified: Jun 2026
First submitted: 16 Oct 2024
Last updated: 23 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real World Outcomes and Treatment Patterns in Brazilian Patients With Hormone Receptor Positive / HER2-negative Unresectable or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06676436
Acronym / sponsor ID: REALNESS / D9673R00053
Conditions: Cancer
Keywords: Cancer, Breast
Study type: Observational
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 30 Nov 2024 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 6 Nov 2024 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study will consist of a convenience cohort; it will include 200 patients. Adult patients who had received treatment in the participant Brazilian centers, with mBC ER-positive (i.e. ER ≥ 1%) and HER2-negative (i.e. HER2 IHC 0, 1 or 2+ with negative ISH), and who had received any CDK4/6i as first-line treatment with any outcome (death, progressive disease, or drug interruption due to any cause) since January 2018 will be enrolled.

Key inclusion criteria (7 listed)

Patient or next of kin/legal representative willing and able to provide written informed consent according to the local regulations unless a waiver is granted by the local IRB/IEC/EC;

Key exclusion criteria (3 listed)

Patients with recurrent disease with a primary tumor showing a different pattern of receptors (i.e. initial BC other than ER ≥ 1% and HER2 negative (IHC 0, 1+ or 2+/ISH negative);
Patients with a concomitant cancer at the time of the diagnosis of MBC HR-positive HER2-negative except for the non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HR-positive HER2-negative BC diagnosis;
Patients who at time of data collection for this study are participating or have participated in an interventional study that remains blinded.

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

Number of patients by drug class and treatment line
Time frame: through study completion, an average of 1 year"
The proportion of HR-positive/HER2-negative patients receiving each drug class in each line of treatment

2 secondary outcomes

Indicate demographic of these patients
Time frame: through study completion, an average of 1 year"
Indicate pathological characteristics of these patients
Time frame: through study completion, an average of 1 year"

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Redacted CRS SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Related trials for Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

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.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by AstraZeneca at 4 sites in Brazil.

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 7 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Brazil. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of patients by drug class and treatment line (time frame: through study completion, an average of 1 year"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06676436.

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 Jun 2026.