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Trial record 1 of 1 for:    NCT02819882
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A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC) (REGISTEM)

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ClinicalTrials.gov Identifier: NCT02819882
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : December 3, 2020
Sponsor:
Collaborators:
Hoffmann-La Roche
Novartis
AstraZeneca
Pfizer
Celgene
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Tracking Information
First Submitted Date June 20, 2016
First Posted Date June 30, 2016
Last Update Posted Date December 3, 2020
Actual Study Start Date August 2016
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2016)
Number of patients with the different breast cancer subtypes and real distribution of them. [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 29, 2019)
  • Breast cancer and heredofamiliar risk according with the patient and tumor characteristics. [ Time Frame: 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. [ Time Frame: 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.
  • Overall trends in outcomes by breast cancer subtypes. [ Time Frame: 8 years ]
    Progression Free Survival (PFS), Overall Survival (OS) and Death will be evaluated between the different cancer subtypes. We will evaluate the prognostic relevance of the intrinsic subtypes.
  • Influence of primary tumor surgery in patient outcomes [ Time Frame: 8 years ]
    Progression Free Survival (PFS), Overall Survival (OS) and Death will be evaluated considering the type of surgery of the primary tumor.
  • Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis [ Time Frame: 8 years ]
    Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis
  • Influence of local therapy (surgery, radiotherapy and radiofrequency) in the outcome of patients with oligometastatic disease [ Time Frame: 8 years ]
    PFS, OS and Death will be evaluated in with oligometastatic disease and with or without local therapy.
  • Prevalence (at entry) and incidence (during the observation period) of pregnancies, abortions and pregnancy outcomes. [ Time Frame: 8 years ]
    Number of patients pregnant, number of patients pregnant with abortions, and pregnancy outcomes.
  • Number of participants with specific biomarkers on tumor and blood samples. [ Time Frame: 8 years ]
    to improve the understanding of metastatic breast cancer by performing analysis on tumor and blood samples.
  • IHC/ISH discrepancies between the primary tumor and the metastasis in patients with biopsy of the metastatic lesions. [ Time Frame: 8 years ]
    It will be performed a comparison between the Immunohistochemistry (IHC)/ In Situ Hybridization (ISH) characteristics of the primary tumor and the metastatic lesion(s).
Original Secondary Outcome Measures
 (submitted: June 27, 2016)
  • Breast cancer and heredofamiliar risk acoording with the patient and tumor characteristics. [ Time Frame: 8 years ]
  • Differences in the development disease in the group of male vs female patients. [ Time Frame: 8 years ]
  • Evolution of number of patients by molecular subtypes of breast cancer. [ Time Frame: 8 years ]
  • Influence of primary tumor surgery in patient outcomes [ Time Frame: 8 years ]
  • Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis [ Time Frame: 8 years ]
  • Influence of local therapy (surgery, radiotherapy and radiofrequency) in the outcome of patients with oligometasta [ Time Frame: 8 years ]
  • Prevalence (at entry) and incidence (during the observation period) of pregnancies, abortions and pregnancy outcomes. [ Time Frame: 8 years ]
  • Number of participants with specific biomarkers on tumor and blood samples. [ Time Frame: 8 years ]
    to improve the understanding of metastatic breast cancer by performing analysis on tumor and blood samples.
  • IHC/ISH discrepancies between the primary tumor and the metastasis in patients with biopsy of the metastatic lesions. [ Time Frame: 8 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
Official Title A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
Brief Summary This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Blood samples Primary and metastatic lesion tissue samples
Sampling Method Non-Probability Sample
Study Population 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).
Condition Breast Neoplasms
Intervention Other: No intervention
Study Groups/Cohorts
  • 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%).
    Intervention: 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%).
    Intervention: Other: No intervention
  • Luminal B-like (HER2 positive) subtype:
    Patients that express ER and HER2 irrespective of PgR or Ki67 status.
    Intervention: Other: No intervention
  • HER2-enriched subtype
    Patients that express HER2 and don't express ER or PgR.
    Intervention: Other: No intervention
  • Triple Negative (TN) subtype
    Patients who are negative for the expression of ER, PgR and HER2.
    Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 27, 2016)
1400
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: MS Study Project Manager +34 916892870 inicio_ensayos@geicam.org
Contact: Start-Up Unit Manager +34 916892870 inicio_ensayos@geicam.org
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02819882
Other Study ID Numbers GEICAM 2014-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Spanish Breast Cancer Research Group
Study Sponsor Spanish Breast Cancer Research Group
Collaborators
  • 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
PRS Account Spanish Breast Cancer Research Group
Verification Date December 2020