REGISTEM: A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)

Sponsor

Spanish Breast Cancer Research Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT02819882

Collaborator

Hoffmann-La Roche (Industry), Novartis (Industry), AstraZeneca (Industry), Pfizer (Industry), Celgene (Industry)

1,400

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Other: No intervention

Detailed Description

The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time.

The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)

Actual Study Start Date :

Aug 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Luminal A-like subtype Patients that express Estrogen receptor (ER), express Progesterone Receptor (PgR)+ (≥ 20%), don't express HER2 and have Ki-67 'low' (< 14%).	Other: No intervention
Luminal B-like (HER2 negative) subtype: Patients that express ER and are either PgR- or low (< 20%) and/or Ki67 'high' (≥ 14%).	Other: No intervention
Luminal B-like (HER2 positive) subtype: Patients that express ER and HER2 irrespective of PgR or Ki67 status.	Other: No intervention
HER2-enriched subtype Patients that express HER2 and don't express ER or PgR.	Other: No intervention
Triple Negative (TN) subtype Patients who are negative for the expression of ER, PgR and HER2.	Other: No intervention

Outcome Measures

Primary Outcome Measures

Number of patients with the different breast cancer subtypes and real distribution of them. [8 years]
Number of patients with the different breast cancer subtypes (Luminal A-like, Luminal B-like [HER2 negative], Luminal B-like [HER2 positive], HER2-enriched and Triple Negative) of the unresectable locally advanced or metastatic disease

Secondary Outcome Measures

Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk. [8 years]
It will be performed a table with patient and tumor characteristics including only those patients with heredofamiliar risk.
Differences in the development disease in the group of male vs female patients. [8 years]
It will be performed an analysis separately for each subtype and by male and female and it will analyse if there are any significative difference between them.
Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis [8 years]
Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis
Number of participants with specific biomarkers on tumor and blood samples. [8 years]
to improve the understanding of metastatic breast cancer by performing analysis on tumor and blood samples.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients (males or females) diagnosed with unresectable locally advanced or MBC (either after a recurrence or as first diagnosis) from January 2016.
Able and willing to provide written informed consent.
Age ≥ 18 years.
Availability to medical records access and all data related to the disease management.

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General de Elche	Elche	Alicante	Spain	03203
2	Althaia-Xarxa Assistencial de Manresa	Manresa	Barcelona	Spain	08243
3	Consorci Sanitari de Terrassa	Terrassa	Barcelona	Spain	08227
4	Hospital Universitario Donostia	San Sebastián	Donostia	Spain	20014
5	Hospital Dr. Negrín	Las Palmas de Gran Canaria	Gran Canaria	Spain	35010
6	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid	Spain	28922
7	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid	Spain	28942
8	Hospital Universitario Severo Ochoa	Leganés	Madrid	Spain	28911
9	Hospital Infanta Sofía	San Sebastián de los Reyes	Madrid	Spain	28702
10	Hospital Son Llatzer	Palma de Mallorca	Mallorca	Spain	07198
11	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain	31008
12	Hospital Universitario de Canarias	Santa Cruz de Tenerife	Tenerife	Spain	38320
13	Hospital de Sagunto	Sagunto	Valencia	Spain	46520
14	Hospital Universitario de Basurto	Bilbao	Vizcaya	Spain	48013
15	Complejo Hospitalario Universitario A Coruña	A Coruña		Spain	15006
16	Complejo Hospitalario Universitario de Albacete	Albacete		Spain	02006
17	Hospital San Juan de Alicante	Alicante		Spain	03550
18	Hospital del Mar	Barcelona		Spain	08003
19	Hospital Clinic de Barcelona	Barcelona		Spain	08036
20	Hospital Santa Creu i Sant Pau	Barcelona		Spain	08041
21	ICO L´Hospitalet	Barcelona		Spain	08908
22	Hospital Universitario Germans Trias i Pujol	Barcelona		Spain	08916
23	Hospital Moisés Broggi_institut Catalá D´Oncologia	Barcelona		Spain	08970
24	Hospital Universitario Reina Sofía	Córdoba		Spain	14004
25	Hospital de León	León		Spain	24071
26	Hospital Lucus Augusti	Lugo		Spain	27003
27	Hospital Universitario La Princesa	Madrid		Spain	28006
28	Hospital General Universitario Gregorio Marañón	Madrid		Spain	28007
29	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia		Spain	30120
30	Hospital Universitario de Málaga	Málaga		Spain	29010
31	Hospital Clínico Universitario de Salamanca	Salamanca		Spain	37007
32	Hospital Universitario Virgen del Rocío	Sevilla		Spain	41013
33	Hospital Virgen de la Salud	Toledo		Spain	45004
34	IVO-Instituto Valenciano de Oncología	Valencia		Spain	46009
35	Hospital Clínico Universitario de Valencia	Valencia		Spain	46010
36	Hosital General de Valencia	Valencia		Spain	46014
37	Hospital Universitario Dr. Peset	Valencia		Spain	46017
38	Hospital Clínico Lozano Blesa	Zaragoza		Spain	50009
39	Hospital Miguel Servet	Zaragoza		Spain	50009
40	Hospital Nuestra Señora de Sonsoles	Ávila		Spain	05004

Sponsors and Collaborators

Spanish Breast Cancer Research Group
Hoffmann-La Roche
Novartis
AstraZeneca
Pfizer
Celgene

Investigators

Study Director: Study Director, Hospital Universitario Fundación Alcorcón, Madrid
Study Director: Study Director, Hospital de Donostia, San Sebastián
Study Director: Study Director, Hospital Universitario Gregorio Marañón, Madrid
Study Director: Study Director, Hospital Universitario Reina Sofía,Córdoba