This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally advanced and/or metastatic breast carcinoma.
Currently available standard therapies for HER2 overexpressed metastatic breast cancers (MBC) include treatments with chemotherapy or hormonal therapy, alone or in combination with medications that target HER2 gene, such as Trastuzumab or Pertuzumab. This study will examine the effect of treating HER2 overexpressed MBC with the combination of Trastuzumab plus Pertuzumab, without hormonal or chemotherapy, as a first line treatment. If patients progress on this treatment, they will receive hormonal or chemotherapy in addition to the Trastuzumab plus Pertuzumab treatment. The objective is to see how the overall response rate for this treatment compares to other first line treatments in the same patient population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
University of Maryland Marlene & Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States
Overall Response Rate (ORR) in Patients
Defined as the total of complete response (CR) defined as a disappearance of all target lesions, partial response (PR) defined as \>= 30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) \>= 27 weeks among the total number of participants as defined by the Response Evaluation in Solid Tumors (RECIST) 1.1 response criteria.
Time frame: Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 months
Progression-free Survival (PFS)
Progression Free Survival in treatment cohorts 1 and 2 as well as arms A and B from the time on study until progression of disease or death
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
Overall Survival (OS)
Overall survival (OS) in treatment cohorts 1 and 2 as well as arms A and B from the time on study until death
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion, an average of 2 years.
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
the safety and tolerability of Trastuzumab and Pertuzumab alone and in combination with hormonal therapy or single agent chemotherapy. in HER2+ MBC patients
Time frame: Participants were followed during the study and for 30 days after completion of the study treatment, up to 12 months
Quality of Life Via Patient-reported Outcomes
quality of life and treatment side effects via patient-reported and investigator reported outcomes
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Time frame: Duration of study, participants were followed every cycle up to 11 months.