Capivasertib for Triple Negative Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Triple Negative Breast CancerCapivasertib - Drug
Eligibility
18 - 130
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination of drugs to treat TNBC compared to the current standard of care.

Eligible Conditions
  • Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: approximately up to 42 months

Month 1
Minimum plasma concentration(Cmin), plasma concentration1-2 hours post-dose (C1-2h) and 4 hours post-dose (C4h) during months 1 and 2
Month 42
Overall Survival (OS)
Month 42
Progression-Free Survival (PFS)
Month 42
Investigator assessment of PFS2
Month 42
Clinical Benefit Rate (CBR)
Duration of Response (DoR)
Response Rate (ORR)
Safety and tolerability of drugs by assessment of AEs/SAEs
Month 42
EORTC QLQ BR23(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module)
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Capivasertib + Paclitaxel
1 of 2
Placebo + Paclitaxel
1 of 2

Experimental Treatment

Non-Treatment Group

924 Total Participants · 2 Treatment Groups

Primary Treatment: Capivasertib · Has Placebo Group · Phase 3

Capivasertib + PaclitaxelExperimental Group · 2 Interventions: Capivasertib, Paclitaxel · Intervention Types: Drug, Drug
Placebo + PaclitaxelPlaceboComparator Group · 2 Interventions: Placebo, Paclitaxel · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capivasertib
Not yet FDA approved
Paclitaxel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately up to 42 months

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,988 Previous Clinical Trials
91,856,313 Total Patients Enrolled
Peter Schmid, MD,PhD,FRCPPrincipal InvestigatorCentre for Experimental Cancer Medicine (CECM), Barts Cancer Institute

Eligibility Criteria

Age 18 - 130 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A FFPE tumor sample from a primary or recurrent cancer is needed.
The text is about a tumour that has been analysed and it has been confirmed that it is a type of TNBC.
Patients who have metastatic or locally recurrent disease that is not amenable to resection with curative intent are not eligible to participate in this study
according to RECIST 1.1 A disease that can be measured using the RECIST 1.1 criteria, or a lesion that is considered to be a disease by CT or MRI scan, even if it does not meet the RECIST 1.1 criteria.