Observational Study on the Treatment of Patients With Metastatic Breast Cancer

NCT06676436 | Completed

• 1 other identifier: D9673R00053
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cancer

Keywords

Cancer; Breast

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 1 year"

Secondary Outcomes (2)

• Indicate demographic of these patients

  through study completion, an average of 1 year"

• Indicate pathological characteristics of these patients

  through study completion, an average of 1 year"

Other Outcomes (1)

• To describe the real-world Time to Next Treatment (rwTTNT) for each line of treatment

  through study completion, an average of 1 year"

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Fortaleza, Brazil

Location

Research Site

Porto Alegre, Brazil

Location

Research Site

Salvador, Brazil

Location

Research Site

São Paulo, Brazil

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: November 6, 2024
• Study Start: November 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

BR (4)