Survival Endpoints in Women Treated for Metastatic Breast Cancer: Contribution of Real-life Databases

Institut Bergonié

Status: Completed

Conditions: Metastatic Breast Cancer

Treatments: Drug: Combination of endocrine therapy and targeted treatment; Drug: Combination of chemotherapy, endocrine therapy and targeted treatment; Drug: Chemotherapy (exclusive); Drug: Endocrine therapy (exclusive); Drug: Chemotherapy and targeted treatment; Drug: Combination of endocrine therapy and chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03676257

IB-2017DATECAN-ESME

Details and patient eligibility

About

Overall survival (OS) is considered the most reliable cancer endpoint and used by the Health Rregulatory authorities (HRA). OS presents multiple advantages in cancer randomized controlled trials (RCT): it is universally accepted as a measure of clinical benefit for the patient; it is objectively defined, both in terms of events and date of incidence; it is easily and precisely measured and thus reproducible; it can be exhaustively collected. As such, OS has been validated by HRAs. On the other hand, OS presents some limitations. Observing a benefit on OS may require a large number of patients and/or considerable time for patient follow-up. Costs for trials may be increased, and there might be delays in the introduction of possible beneficial treatments for patients. The development of alternative endpoints that could capture treatment benefit appropriately and be measurable earlier, is central for the evolution of clinical research in oncology.

Real world data (RWD) are defined as other sources than clinical trials such as: electronic medical records, registries, insurance claims, pharmacy records, death certificates and other patient-generated data.

This research is aimed at (i) describing the existing endpoints of survival in real-life setting, (ii) comparing the correlation at individual level with data to clinical trials for related to anti-HER2 targeted therapies and endocrine therapies in MBC. We will investigate the individual correlation between candidate surrogate endpoints and overall survival in a population-based record-computerized database centralizing data on about 20,000 patients from 2008 to 2017 in France.

This work should lead to the estimation of various time-to event endpoints (e.g. OS, PFS, etc), in the real-life setting, for mBC patients. In addition, we will estimate their individual correlation with OS, which should help us highlight potential surrogate endpoints in this setting. We will focuss on three distinct population, accounting for a large population of mBS patients: : patients treated with anti-HER2 targeted agents, patients treated with endocrine therapies and elderly population.

Enrollment: 20,033 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

ELIGIBILITY

• female patients older than 18 years
• diagnosis of metastatic breast cancer (de novo disease or first metastatic recurrence) between January 1, 2008, and December 31, 2017
• received a fist-line systemic treatment such as chemotherapy, endocrine therapy or targeted therapy, whatever the sequence (monotherapy or combination of therapies using distinct mechanisms of actions, i.e., polytherapy).

Trial design

20,033 participants in 4 patient groups

Women with a diagnosis of HR+ /HER2- metastatic breast cancer (mBC)

Description:

Women with a diagnosis of HR+ /HER2- metastatic breast cancer (mBC)

Treatment:

Drug: Combination of endocrine therapy and chemotherapy

Drug: Chemotherapy and targeted treatment

Drug: Endocrine therapy (exclusive)

Drug: Chemotherapy (exclusive)

Drug: Combination of chemotherapy, endocrine therapy and targeted treatment

Drug: Combination of endocrine therapy and targeted treatment

Women with a diagnosis of HR- /HER2- metastatic breast cancer (mBC)

Description:

Women with a diagnosis of HR- /HER2- metastatic breast cancer (mBC)

Treatment:

Drug: Chemotherapy and targeted treatment

Drug: Chemotherapy (exclusive)

Women with a diagnosis of HR+ /HER2+ metastatic breast cancer (mBC)

Description:

Women with a diagnosis of HR+ /HER2+ metastatic breast cancer (mBC)

Treatment:

Drug: Combination of endocrine therapy and chemotherapy

Drug: Chemotherapy and targeted treatment

Drug: Endocrine therapy (exclusive)

Drug: Chemotherapy (exclusive)

Drug: Combination of chemotherapy, endocrine therapy and targeted treatment

Drug: Combination of endocrine therapy and targeted treatment

Women with a diagnosis of HR- /HER2+ metastatic breast cancer (mBC)

Description:

Women with a diagnosis of HR- /HER2+ metastatic breast cancer (mBC)

Treatment:

Drug: Chemotherapy and targeted treatment

Drug: Chemotherapy (exclusive)