An observational study in Breast Neoplasms, sponsored by BELEN RUIZ-ANTORAN. Completed at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-05.
Sponsored by BELEN RUIZ-ANTORAN · Observational
The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program
This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.
The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 220 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with BELEN RUIZ-ANTORAN as lead sponsor.
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This study will include a cohort of approximately 700 adult patients from the Spain with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab under compassionate use or early access program. The decision to initiate use of Trastuzumab emtansine (T-DM1) and Pertuzumab is made independently by the participant and their health care provider and is not mandated by the study design or protocol.
Exclusion Criteria:
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Pertuzumab under Spanish compassionate use or early access program
Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) under Spanish compassionate use or early access program
Overall survival.
The time between the date of start of treatment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
Time frame: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
Progression free survival.
The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features).
Time frame: Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
Best overall response rate
Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record
Time frame: Through study completion, an average of 4 year
Duration of response (DOR)
The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first. At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete.
Time frame: Through study completion, an average of 4 year
Time to treatment failure
Time frame: Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
Time to Objective Response
The time from start of treatment to the date of the first confirmed response (evaluated for responders only)
Time frame: Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
Time to change treatment
Time frame: Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
Time to next treatment
Time frame: Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
All suspected Grade 3/4/5 adverse reactions
Time frame: Through study completion, an average of 4 year
Adverse events of special interest to anti HER2 Mab (AESI)
* AESIs regarding treatment with T-DM1: Hepatic disorder (specific analytical alteration) * AESIs regarding treatment with Pertuzumab: Interstitial Lung Disease
Time frame: Through study completion, an average of 4 year
AEs of scientific interest
* An asymptomatic decline in LVEF requiring treatment or leading to discontinuation of study treatment (regarding treatment with T-DM1 and Pertuzumab) * Other AEs leading to treatment discontinuation
Time frame: Through study completion, an average of 4 year
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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