None listed
Conditions
Interventions
Paclitaxel will be administered as a weekly single intravenous (IV) infusion of 80 mg/m2 given over approximately 1 hour via a rate-controlling device. Patients will receive 3 consecutive weekly paclitaxel infusions (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.
Capivasertib will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.
Cap
Paclitaxel will be administered as a weekly single intravenous (IV) infusion of 80 mg/m2 given over approximately 1 hour via a rate-controlling device. Patients will receive 3 consecutive weekly paclitaxel infusions (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.
Placebo will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.
Placebo
Sponsors
AstraZeneca AB,
Eligibility
Inclusion criteria
Inclusion criteria: 1 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol (CSP) 2 Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses 3 For inclusion in the optional exploratory genetic and/or biomarker research, provision of signed and dated written genetic and/or biomarker informed consents, respectively, prior to collection of sample. 4 Patients must be aged ≥18 years (aged ≥20 years in Japan) at the time of signing the ICF 5 Histologically-confirmed breast cancer Please kindly review pages 42-44 of clinical protocol
Exclusion criteria
Exclusion criteria: 1 Malignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer) 2 Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo) 3 Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment 4 Pre-existing sensory or motor polyneuropathy ≥grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5) 5 With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment Please kindly review pages 44-47 of clinical protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Investigator assessment (in accordance with RECIST 1.1) of PFS, defined as the time from date of randomisation to the date of progression or death due to any cause. Measure:To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by investigator assessment of progression free survival (PFS). Timepoints:Every 8 weeks for the first 2 years and every 12 weeks thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Investigator assessment (in accordance with RECIST 1.1) of PFS, defined as the time from date of randomisation to the date of progression or death due to any cause. Measure:To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by investigator assessment of PFS. Timepoints:Since randomization till the end of the trial ; Outcome name:Investigator assessment of PFS2, defined as the time from randomisation until second disease progression or death due to any cause. Measure:To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by investigator assessment of PFS2. Timepoints:Since ranromization till end of the trial ; Outcome name:AEs/SAEs; vital signs; collection of clinical chemistry, haematology, glucose metabolism parameters; ECGs parameters. Measure:To evaluate the safety and tolerability of capivasertib + paclitaxel vs placebo + paclitaxel. Timepoints:Till end of the trial ; Outcome name:Evaluation of EORTC QLQ C30 and EORTC QLQ BR23 scale/item scores including change from baseline and time to deterioration. Measure:To assess the impact of capivasertib + paclitaxel vs placebo + paclitaxel on patients’ disease-related symptoms, physical function, and HRQoL. Timepoints:Till end of the trial | — |
Countries
Arabia Saudi, Argentina, Brazil, Canada, China, Colombia, Czech Republic, France, Greece, Hungary, India, Japan, Korea South, Malasya, Mexico, New Zealand, Peru, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kindgdom, United States, Vietnam
Contacts
Public ContactUrsula Rodriguez-Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed