Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib (TRASTYVERE)

• ClinicalTrials.gov Identifier: NCT02056080
• Recruitment Status: Completed
• First Posted: February 5, 2014
• Last Update Posted: September 9, 2019
• Sponsor: MedSIR
• Information provided by (Responsible Party): MedSIR

Study Description

Brief Summary:

A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011

Condition or disease
Breast Neoplasm

Study Design

• Study Type: Observational
• Actual Enrollment: 111 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Observational, Retrospective and Multicenter Study to Evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib
• Actual Study Start Date: January 2013
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Clinical response rate assessed by RECIST criteria [ Time Frame: Up to 24 weeks from the first clinical response rate assessment ]

   clinical benefit rate (CBR): defined as the percentage of patients who achieved an objective response (CR or PR) or tumor stabilization for at least 24 weeks or more during the period of treatment with the combination TL.

   This variable will be assessed by RECIST v 1.1

Secondary Outcome Measures :

1. To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib [ Time Frame: Up to one year from the last dose of TL ]
   The progression will be evaluated by RECIST v 1.1.
2. To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines. [ Time Frame: Up to 24 weeks from the last dose of TL ]
   clinical benefit: defined as reaching a (complete or partial) objective response or stabilization of tumor for more than 24 weeks
3. To compare the time to progression of different subpopulations according to the biological characteristics of the tumor. [ Time Frame: Up to one year from the last dose of TL ]
   The progression will be evaluated by RECIST v 1.1.
4. To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit [ Time Frame: Up to one year from the last dose of TL ]
   Adverse reactions observed during treatment of the combination TL, measured with scale CTCAE v.4

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with HER2 positive metastatic breast cancer who progressed to antiHER2 therapy with trastuzumab and / or lapatinib for the metastasic disease and that between January 2005 and December 2011, began treatment with the combination of trastuzumab and lapatinib (TL).

Criteria

Inclusion Criteria:

• Confirmed diagnosis of metastatic breast cancer HER2-positive phenotype (confirmed by IHC 3 + or FISH positive)
• Older than 18 years
• Progressed to at least one prior treatment line for MBC with trastuzumab and / or lapatinib, either as monotherapy or in combination with chemotherapy or hormonal therapy schemes
• Having the patient's complete medical history that contains all lines antiHER2 therapy treatment
• Being a patient who initiated the combination of trastuzumab and lapatinib between January 2005 and December 2011
• Inform the patient and get the signature of the informed consent

Exclusion Criteria:

• Not having phenotypic classification of the tumor by IHC or FISH test for HER2
• Being a patient with HER2-negative phenotype(FISH negative or IHC in range [0-2 +] without FISH)
• Being a patient who received the trastuzumab and/or lapatinib treatment (TL) in combination with chemotherapy
• Being a patient who, since January 2012, began TL therapy for metastatic disease.

Contacts and Locations

Locations

Spain

Barcelona, Spain

Córdoba, Spain

Girona, Spain

Jaen, Spain

Madrid, Spain

Pamplona, Spain

Salamanca, Spain

Santiago de Compostela, Spain

Sevilla, Spain

Valencia, Spain

Zaragoza, Spain

Sponsors and Collaborators

MedSIR

Investigators

• Principal Investigator: Joaquin Gávila, MD; Valencia

More Information

• Responsible Party: MedSIR
• ClinicalTrials.gov Identifier: NCT02056080
• Other Study ID Numbers: MED-DBL-2012-01
• First Posted: February 5, 2014
• Last Update Posted: September 9, 2019
• Last Verified: September 2019

Keywords provided by MedSIR:

Breast Neoplasm; Receptor,HER2; Antineoplastic agent; Antibodies, monoclonal; Trastuzumab, Lapatinib; Protein kinase inhibitors; quinazolines

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases