neoadjuvant hormone-receptor positive HER2-negative breast cancer
Conditions
Interventions
Product Name: BYL719
Product Code: BYL719
Pharmaceutical Form: Tablet
INN or Proposed INN: Not available
CAS Number: 1217486-61-7
Current Sponsor code: BYL719
Other descriptive name: BYL719
Concentrat
Sponsors
Novartis Farmacéutica , S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient has T2-T3, any N, M0, operable breast cancer. - Patients must have measurable tumor. - Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level. - Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing. Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing. - Patient has known PIK3CA mutation status (mutated or wild-type) as defined by a Novartis designated laboratory. (Patients with unknown PIK3CA mutation status will not be enrolled). - Patient has Ki67 level status determined centrally. - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ? 1 which the investigator believes is stable at the time of screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
Exclusion criteria: - Patient has locally recurrent or metastatic disease. - Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before study entry. - Patient with clinically manifest diabetes mellitus (fasting glucose > 120 mg/dl or 6.7 mmol/L), or documented steroid induced diabetes mellitus. - Patient has a score ? 12 on the PHQ-9 questionnaire. - Patient selects a response of ?1, 2 or 3? to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9). - Patient has a GAD-7 mood scale score ? 15. - Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or with an active severe personality disorder (defined according to DSM- IV). Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug. - Patient has ? CTCAE grade 3 anxiety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the anti-tumor activity of BYL719 QD plus letrozole and buparlisib QD plus letrozole versus letrozole alone in increasing the pathologic complete response (pCR) rate during neo-adjuvant treatment for each of the two groups: i) PIK3CA mutated and ii) PIK3CA wild tumor types.;Secondary Objective: - objective response rate (RR, complete + partial) for each of the 2 groups, namely i) PIK3CA mutated and ii) PIK3CA wild tumor types. -- safety and tolerability of the combinations for each of the two groups... --estimate rate of breast conserving surgery;Primary end point(s): Pathologic complete response;Timepoint(s) of evaluation of this end point: following 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): --ORR --safety & tolerability --breast conserving surgery --changes in Ki67 --assessment of PEPI score --PK for buparlisib/BYL719 and letrozole;Timepoint(s) of evaluation of this end point: Along the trial | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Lebanon, Netherlands, Norway, Peru, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactDepartamento Médico Oncología (GMO)
Novartis Farmacéutica, S.A.
Outcome results
None listed