Early stage triple negative breast cancer. MedDRA version: 17.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ipatasertib
Product Code: GDC-0068 100 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: ipatasertib
Other descriptive name: RO5532961
Concentration unit: mg milligram(s)
Concentration
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Premenopausal or postmenopausal women, age >18 years ? Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ? Histologically documented triple-negative carcinoma of the breast with all of the following characteristics: - Primary tumor > or eqaul to 1.5 cm in largest diameter (cT1-3) by MRI. In the case of a multifocal tumor (defined as the presence of two or more foci of cancer within the same breast quadrant), the largest lesion must be > or equal to 1.5 cm and designated as the ?index? lesion for all subsequent tumor evaluations. - Stage I to operable Stage IIIa breast cancer ? Adequate hematologic and organ function within 14 days before the first study treatment, defined by the following: - Neutrophils (absolute neutrophil count [ANC] > or equal to 1500/microL) - Hemoglobin > or equal to 9 g/dL - Platelet count > or equal 100,000/microL - Fasting serum glucose or equal to 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: ? Any prior treatment for the current primary invasive breast cancer ? Patients with cT4 or cN3 stage breast tumors ? Metastatic (Stage IV) breast cancer ? Bilateral invasive breast cancer ? Multicentric breast cancer (the presence of more than one tumor in different quadrants of the breast) ? History of Type I or Type II diabetes mellitus requiring insulin - Patients who are on a stable dose of oral diabetes medication > or equal to 2 weeks prior to initiation of study treatment are eligible for enrollment ? Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator?s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To estimate the efficacy of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in patients with early stage TNBC, as measured by evaluation of pCR rate within the breast and axilla (ypT0/Tis ypN0) in all patients and in patients with PTEN low tumors.;Secondary Objective: - To evaluate objective response rate (ORR) assessed by breast MRI via modified Response Evaluation Criteria in Solid Tumors (RECIST) of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in all patients and in patients with PTEN low tumors; - To estimate the clinical activity, as measured by pCR (ypT0/Tis and ypT0/Tis ypN0) and ORR of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in patients who are Akt diagnostic positive; - To assess pCR rates according to subtypes of breast cancer defined by molecular profiles; - To assess the rates of breast-conserving surgery (BCS) and conversion to BCS of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in women with T2 or T3 tumors.;Primary end point(s): The rate of pCR in breast and axilla (ypT0/Tis ypN0). The pCR endpoint will be analyzed for all randomized patients and for patients with PTEN low tumors.;Timepoint(s) of evaluation of this end point: Week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Tumor objective response rate (ORR) assessed by breast MRI via modified RECIST criteria, in all patients and in patients with PTEN-low tumors ? The rate of pCR and ORR in patients whose tumors are Akt Dx+ (defined by PTEN status, INPP4B status, and PI3K alterations) ? The rate of pCR according to subtypes of breast cancer defined by molecular profiles; e.g., PAM50 classifier ? The rate of breast-conserving surgery (BCS) and conversion to BCS in patients with T2 or T3 tumors;Timepoint(s) of evaluation of this end point: Week 10, Week 19 | — |
Countries
Portugal, Spain, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
Outcome results
None listed