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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)
Full description
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)
Enrollment
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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
Primary purpose
Allocation
Interventional model
Masking
923 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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