Breast cancer
Conditions
Brief summary
The primary objective of this trial is to prospectively evaluate the predictive and prognostic value of pre-treatment assessment of a panel of 300 known potential driver mutations in breast cancer by next generation sequencing of tumor DNA.
Detailed description
To assess how genetic/epigenetic disturbances in tumor tissue change during therapy, The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison., Tumor Ki67 reduction after 2 and 5 weeks of treatment in Arm A., To estimate recurrence-free and overall survival when patients are treated with the optimal personalized treatment available as of 2016, using historical data for comparison., To evaluate the percentage of patients completing neoadjuvant treatment as outlined in Figure 1 and completing surgery., Breast conserving surgery rate (potential to avoid mastectomy)., To assess the safety and tolerability of the study treatment given.
Interventions
DRUGLynparza 150 mg film-coated tablets
DRUGPerjeta 420 mg concentrate for solution for infusion
Sponsors
Helse Bergen HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial is to prospectively evaluate the predictive and prognostic value of pre-treatment assessment of a panel of 300 known potential driver mutations in breast cancer by next generation sequencing of tumor DNA. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess how genetic/epigenetic disturbances in tumor tissue change during therapy, The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison., Tumor Ki67 reduction after 2 and 5 weeks of treatment in Arm A., To estimate recurrence-free and overall survival when patients are treated with the optimal personalized treatment available as of 2016, using historical data for comparison., To evaluate the percentage of patients completing neoadjuvant treatment as outlined in Figure 1 and completing surgery., Breast conserving surgery rate (potential to avoid mastectomy)., To assess the safety and tolerability of the study treatment given. | — |
Countries
Norway
Outcome results
None listed