A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.
Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple negative Breast Cancer (TNBC)
Inclusion Criteria:
Exclusion Criteria:
Prior Chemotherapy in the neoadjuvant or adjuvant setting within 6 months from the end of chemotherapy to the date of randomization; taxane chemotherapy in the neoadjuvant or adjuvant setting within 12 months from the end of chemotherapy to the start of randomization
Prior systematic therapy for inoperable locally advanced or metastatic disease
Prior treatment with any of the treatments listed below. Patients are not eligible to enter the study if they have received any of the medications specified below or are unable to meet the cautions and restrictions:
Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo)
Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5
With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
Any of the following cardiac criteria at screening:
Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening:
Inadequate bone marrow reserve or organ function at screening
Currently pregnant (confirmed with positive pregnancy test) or breast-feeding
CABA, 1414, Argentina
CABA, C1012AAR, Argentina
CABA, C1019ABS, Argentina
CABA, C1426ANZ, Argentina
Ciudad Autonomade Buenos Aires, 1426, Argentina
North York, Ontario M2K 1E1, Canada
Hidaka-shi, 350-1298, Japan
Kitaadachi-gun, 362-0806, Japan
Ota-shi, 373-8550, Japan
Shinagawa-ku, 142-8666, Japan
Shinjuku-ku, 162-8655, Japan
Sunto-gun, 411-8777, Japan
Takasaki-shi, 370-0829, Japan
Cheonan-si, 31151, South Korea
Hospitalet deLlobregat, 08907, Spain
Mueang, 50200, Thailand
Surrey, GU2 7XX, United Kingdom