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Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced 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.

NCT03997123•AstraZeneca

View on ClinicalTrials.gov

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)

Detailed 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)

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed TNBC from most recently collected tumour tissue sample

Exclusion Criteria

•3. ECOG/WHO PS: 0-1
•4. 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
•5. FFPE tumour sample from primary/recurrent cancer
•1. 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
•2. Prior systematic therapy for inoperable locally advanced or metastatic disease
•* AKT, PI3K, and/or mTOR inhibitors
•* Capivasertib in the present study (ie, any dosing with capivasertib due to previous participation in this study)
•* Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long halflife (eg, biologics) as agreed by the sponsor
•* Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to the first dose of study treatment.
•4. Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo)
+14 more criteria

Locations (260)

Research Site

Whittier, California, United States

Research Site

Whittier, California, United States

Research Site

Fort Myers, Florida, United States

Research Site

Miami, Florida, United States

Research Site

St. Petersburg, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Chicago, Illinois, United States

Research Site

Westwood, Kansas, United States

Research Site

Silver Spring, Maryland, United States

Research Site

Detroit, Michigan, United States

Key Dates

Start Date

June 25, 2019

Primary Completion Date

March 16, 2026

Completion Date

March 16, 2026

Last Updated

December 22, 2025

Enrollment

923

ACTUAL participants

Conditions

Triple Negative Breast Neoplasms

Interventions

Capivasertib

DRUG

Paclitaxel

DRUG

Placebo

DRUG

Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery

NCT05973864

Triple Negative Breast Neoplasms

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

NCT03742102

Triple Negative Breast Neoplasms

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COMPLETEDPHASE2

Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

Inclusion Criteria

Exclusion Criteria

Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer

A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study