Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic … (NCT03997123) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC
United States923 participantsStarted 2019-06-25
Plain-language summary
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)
Who can participate
Age range18 Years – 130 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically confirmed TNBC from most recently collected tumour tissue sample
✓. Metastatic or locally recurrent disease; locally recurrent disease most not be amenable to resection with curative intent (patient who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
✓. ECOG/WHO PS: 0-1
✓. Measurable disease according to RECIST 1.1 and/or lytics or mixedbone lesions that can be assessed by CT or MRI in the absence of measurable disease
✓. FFPE tumour sample from primary/recurrent cancer
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
What they're measuring
1
Overall Survival (OS)
Timeframe: The time from date of randomisation to the date of death due to any cause up to approximately 42 months