Triple Negative Breast NeoplasmsPhase 3CAPItello-290NCT03997123

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

A Phase 3 study testing Capivasertib and Paclitaxel in people with Triple Negative Breast Neoplasms, run by AstraZeneca at 260 sites in 30 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Triple Negative Breast Neoplasms
What is being tested?: Capivasertib and Paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 923 participants
Where: 260 sitesin 30 countries
Study dates: 25 Jun 2019to 16 Mar 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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:
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

Show all 22Show fewer

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.
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:
Mean resting corrected QT interval (QTc) >470 msec obtained from 3 consecutive ECGs
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block)
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥2
Uncontrolled hypotension - SBP <90 mmHg and/or DBP <50 mmHg
Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiplegated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive).
Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening:
Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment
HbA1c ≥8.0% (63.9 mmol/mol)
Inadequate bone marrow reserve or organ function at screening
Currently pregnant (confirmed with positive pregnancy test) or breast-feeding

Trial locations and contacts

260 sites in 30 countries.

Country

City, postcode or hospital

260 sites in 30 countries

China30 sites

Research Site
Beijing, 100021
Research Site
Beijing
Research Site
Changchun, 130021
Research Site
Changsha, 410013
Research Site
Changsha, 410078
Research Site
Chengdu, 610000
Research Site
Chengdu, 610072
Research Site
Foshan, 528000
Research Site
Guangzhou, 510060
Research Site
Guiyang, 550004
Research Site
Haikou, 570311
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310009
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Hefei, 230001
Research Site
Jinan, 250117
Research Site
Linyi, 276000
Research Site
Nanchang, 330009
Research Site
Nanjing, 210029
Research Site
Nanyang, 473009
Research Site
Shanghai, 200032
Research Site
Shenyang, 110001
Research Site
Shenyang, 110042
Research Site
Ürümqi, 830000
Research Site
Wenzhou, 325000
Research Site
Wuhan, 430030
Research Site
Wuhan
Research Site
Xi'an, 710061
Research Site
Zhengzhou, 450000

Other trials in China

Japan23 sites

Research Site
Bunkyō City, 113-8431
Research Site
Fukuoka, 811-1395
Research Site
Hidaka-shi, 350-1298
Research Site
Hiroshima, 730-8518
Research Site
Kagoshima, 892-0833
Research Site
Kitaadachi-gun, 362-0806
Research Site
Kōtoku, 135-8550
Research Site
Kumamoto, 860-8556
Research Site
Matsuyama, 791-0280
Research Site
Nagoya, 464-8681
Research Site
Niigata, 951-8566
Research Site
Osaka, 540-0006
Research Site
Osaka, 541-8567
Research Site
Ota-shi, 373-8550
Research Site
Sapporo, 003-0804
Research Site
Sendai, 980-8574
Research Site
Shinagawa-ku, 142-8666
Research Site
Shinjuku-ku, 162-8655
Research Site
Sunto-gun, 411-8777
Research Site
Takasaki-shi, 370-0829
Research Site
Tsu, 514-8507
Research Site
Tsukuba, 305-8576
Research Site
Yokohama, 241-8515

Other trials in Japan

United States22 sites

Research Site
Austin, Texas, 78758
Research Site
Chicago, Illinois, 60637
Research Site
Cincinnati, Ohio, 45220
Research Site
Columbus, Ohio, 43210
Research Site
Detroit, Michigan, 48202
Research Site
Fairfax, Virginia, 22031
Research Site
Fort Myers, Florida, 33901
Research Site
Fort Worth, Texas, 76104
Research Site
Harrisburg, Pennsylvania, 17109
Research Site
Houston, Texas, 77090
Research Site
Miami, Florida, 33136
Research Site
Nashville, Tennessee, 37203
Research Site
Nyack, New York, 10960
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
San Antonio, Texas, 78229
Research Site
Silver Spring, Maryland, 20910
Research Site
St. Petersburg, Florida, 33705
Research Site
Tampa, Florida, 33612
Research Site
Westwood, Kansas, 66205
Research Site
Whittier, California, 90602
Research Site
Whittier, California, 90603

Other trials in United States

South Korea13 sites

Research Site
Busan, 602-739
Research Site
Cheonan-si, 31151
Research Site
Cheongju-si, 28644
Research Site
Daegu, 41404
Research Site
Goyang-si, 10408
Research Site
Incheon, 21565
Research Site
Seongnam-si, 13620
Research Site
Seoul, 02841
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06273
Research Site
Seoul, 06351

Other trials in South Korea

Brazil12 sites

Research Site
Barretos, 14784-400
Research Site
Florianópolis, 88034-000
Research Site
Goiânia, 74605-070
Research Site
Londrina, 86015-520
Research Site
Natal, 59075-740
Research Site
Porto Alegre, 90110-270
Research Site
Porto Alegre, 90619-900
Research Site
Rio de Janeiro, 20560-120
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 01246-000
Research Site
São Paulo, 01317-000
Research Site
São Paulo, 04014-002

Other trials in Brazil

India12 sites

Research Site
Bangalore, 560052
Research Site
Bangalore, 560064
Research Site
Gūrgaon, 122001
Research Site
Kolkata, 700054
Research Site
Kolkata, 700160
Research Site
Mumbai, 400012
Research Site
Mysuru, 570017
Research Site
Nagpur, 440001
Research Site
Nagpur, 440012
Research Site
Nashik, 422002
Research Site
New Delhi, 110085
Research Site
New Delhi, 11029

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Philippines12 sites

Research Site
Bacolod, 6100
Research Site
Baguio City, 2600
Research Site
Cagayan de Oro, 9000
Research Site
Cebu City, 6000
Research Site
Davao City, 8000
Research Site
Iloilo City, 5000
Research Site
Iloilo City
Research Site
Las Piñas, 1740
Research Site
Legaspi, 4500
Research Site
Manila, 1000
Research Site
Quezon City, 1112
Research Site
San Juan City, 1500

Other trials in Philippines

Spain10 sites

Research Site
Badalona, 08916
Research Site
Barcelona, 08025
Research Site
Barcelona, 8035
Research Site
Hospitalet deLlobregat, 08907
Research Site
Jaén, 23007
Research Site
Madrid, 28046
Research Site
Málaga, 29010
Research Site
Seville, 41009
Research Site
Valencia, 46026
Research Site
Zaragoza, 50009

Other trials in Spain

Taiwan10 sites

Research Site
Hsinchu, 300
Research Site
Hualien City, 97002
Research Site
Kaohsiung City, 82445
Research Site
Kaohsiung City, 83301
Research Site
Tainan, 710
Research Site
Tainan, 73657
Research Site
Taipei, 104
Research Site
Taipei, 11217
Research Site
Taipei, 114
Research Site
Taipei, 235

Other trials in Taiwan

Argentina9 sites

Research Site
Buenos Aires, C1125ABD
Research Site
CABA, 1414
Research Site
CABA, C1012AAR
Research Site
CABA, C1019ABS
Research Site
CABA, C1426ANZ
Research Site
Ciudad Autonomade Buenos Aires, 1426
Research Site
La Plata, 1900
Research Site
Mar del Plata, 7600
Research Site
Rosario, 2000

Other trials in Argentina

Russia9 sites

Research Site
Arkhangelsk, 163045
Research Site
Moscow, 115478
Research Site
Moscow, 117997
Research Site
Moscow, 121205
Research Site
Moscow, 121467
Research Site
Saint Petersburg, 190103
Research Site
Saint Petersburg, 197758
Research Site
Volgograd, 400138
Research Site
Yaroslavl, 150054

Other trials in Russia

France8 sites

Research Site
Brest, 29609
Research Site
Lyon, 69008
Research Site
Marseille, 13009
Research Site
Montpellier, 34070
Research Site
Nice, 6189
Research Site
Paris, 75020
Research Site
Saint-Herblain, 44805
Research Site
Villejuif, 94805

Other trials in France

Poland8 sites

Research Site
Bydgoszcz, 85-796
Research Site
Konin, 62-500
Research Site
Poznan, 61-866
Research Site
Racibórz, 47-400
Research Site
Radom, 26-600
Research Site
Tomaszów Mazowiecki, 97-200
Research Site
Warsaw, 01-748
Research Site
Wroclaw, 53-413

Other trials in Poland

Mexico7 sites

Research Site
Aguascalientes, 20230
Research Site
Estado de México, 50080
Research Site
Guadalajara, 44680
Research Site
México, 06725
Research Site
Monterrey, 64710
Research Site
Tuxtla Gutiérrez, 29038
Research Site
Tuxtla Gutiérrez, 29090

Other trials in Mexico

Saudi Arabia7 sites

Research Site
Dammam, 31444
Research Site
Jeddah, 22384
Research Site
Mecca, 24246
Research Site
Riyadh, 11426
Research Site
Riyadh, 11525
Research Site
Riyadh, 12311
Research Site
Riyadh, 12713

Other trials in Saudi Arabia

United Kingdom7 sites

Research Site
Edinburgh, EH4 2XU
Research Site
London, E1 1BB
Research Site
London, NW3 2QG
Research Site
London, SE1 9RT
Research Site
Sheffield, S10 2SJ
Research Site
Surrey, GU2 7XX
Research Site
York, YO31 8HE

Other trials in United Kingdom

Hungary6 sites

Research Site
Budapest, 1062
Research Site
Budapest, 1097
Research Site
Budapest, 1106
Research Site
Győr, 9024
Research Site
Nyíregyháza, 4400
Research Site
Szekszárd, 7100

Other trials in Hungary

Peru6 sites

Research Site
Arequipa, AREQUIPA01
Research Site
Callao, CALLAO 02
Research Site
Lima, 0051
Research Site
Lima, 15033
Research Site
Lima, L27
Research Site
Lima, LIMA 34

Other trials in Peru

Thailand6 sites

Research Site
Bangkok, 10210
Research Site
Bangkok, 10330
Research Site
Bangkok, 10400
Research Site
Bangkok, 10700
Research Site
Hat Yai, 90110
Research Site
Mueang, 50200

Other trials in Thailand

Turkey (Türkiye)6 sites

Research Site
Ankara, 06100
Research Site
Ankara, 06520
Research Site
Istanbul
Research Site
Izmir, 35100
Research Site
Malatya, 44280
Research Site
Mersin, 33070

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Colombia5 sites

Research Site
Floridablanca, 681004
Research Site
Ibague, 730006
Research Site
Medellín, 5001000
Research Site
Montería, 23001
Research Site
Valledupar, 200001

Other trials in Colombia

Greece5 sites

Research Site
Athens, 115 22
Research Site
Athens, 11528
Research Site
Athens, 12462
Research Site
Heraklion, 71110
Research Site
Thessaloniki, 54645

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Canada4 sites

Research Site
Kitchener, Ontario, N2G 1G3
Research Site
North York, Ontario, M2K 1E1
Research Site
Toronto, Ontario, M5G 1X5
Research Site
Victoria, British Columbia, V8R 6V5

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Czechia4 sites

Research Site
Hradec Králové, 500 05
Research Site
Olomouc, 77900
Research Site
Prague, 100 34
Research Site
Prague, 128 08

Other trials in Czechia

Malaysia4 sites

Research Site
Kuala Lumpur, 50586
Research Site
Kuala Lumpur, 59100
Research Site
Kuala Selangor, 62250
Research Site
Kuching, 93586

Other trials in Malaysia

Portugal4 sites

Research Site
Lisbon, 1099-023
Research Site
Lisbon, 1400-038
Research Site
Lisbon, 1649-035
Research Site
Porto, 4099-001

Other trials in Portugal

South Africa4 sites

Research Site
Johannesburg, 2193
Research Site
Johannesburg, 2196
Research Site
Pretoria, 0002
Research Site
Pretoria, 0084

Other trials in South Africa

Sweden3 sites

Research Site
Gothenburg, 413 45
Research Site
Lund, 221 85
Research Site
Stockholm, 118 83

Other trials in Sweden

Vietnam3 sites

Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City

Other trials in Vietnam

Slovakia1 site

Research Site
Bratislava, 833 01

Other trials in Slovakia

About this study

Official title: 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.

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)

Read the 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)

Conditions: Triple Negative Breast Neoplasms
Being tested: Capivasertib, Paclitaxel, Placebo
Keywords: Breast Cancer;, Triple-negative Breast Cancer
Medical subject headings: Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CapivasertibDrug
Also called AZD5363
400 mg (2 oral tablets) given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Study treatment will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.
PaclitaxelDrug
80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.
PlaceboDrug
Also called Placebo tablets to match capivasertib
Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week offtreatment within each 28-day treatment cycle

Study groups in NCT03997123
Study group	Role	What they receive
Capivasertib + Paclitaxel	Experimental	Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Capivasertib: Oral tablets. 400 mg of Capivasertib (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Receives: Drug: Capivasertib; Drug: Paclitaxel
Placebo + Paclitaxel	Placebo comparator	Paclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Receives: Drug: Paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival (OS)
Overall Survival (OS)
Measured: The time from date of randomisation to the date of death due to any cause up to approximately 42 months

Secondary outcomes (9)

Progression-Free Survival (PFS)
Progression-Free Survival by investigator assessment (in accordance with RECIST 1.1)
Measured: The time from date of randomization to the date of progression or death due to any cause, whichever occurs earlier, up to approximately 42 months
Investigator assessment of PFS2
PFS2 - time from randomisation to second progression or death
Measured: Time from randomization to second progression or death due to any cause up to approximately 42 months
Response Rate (ORR)
Response Rate (ORR) - percentage of patients with at least one investigator-assessed visit response of complete or partial response (as assessed by the investigator, using RECIST 1.1)
Measured: Up to approximately 42 months
Safety and tolerability of drugs by assessment of AEs/SAEs
Graded according to the National Cancer Institute (NCI CTCAE)
Measured: Up to approximately 42 months
Minimum plasma concentration(Cmin), plasma concentration1-2 hours post-dose (C1-2h) and 4 hours post-dose (C4h) during months 1 and 2
Plasma PK parameters derived from a population model as data permits
Measured: During months 1 and 2
EORTC QLQ BR23(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module)
The self-administered instrument includes 23-items and yields 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Items are scored on a 4-point verbal rating scale: "Not at All," "A Little," "Quite a Bit," and "Very Much". Scores are transformed to a 0 to 100 scale, where higher scores indicate better unctioning, better HRQoL, or greater level of symptom.
Measured: approximately up to 42 months
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items)
5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), and global health status/QoL scale, along with 5 individual item symptom scores (appetite loss, dyspnoea, insomnia, constipation, and diarrhoea. The EORTC QLQ-C30 will be scored according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). Higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales/scores represent greater symptom severity.
Measured: approximately up to 42 months
Duration of Response (DoR)
Duration of Response (DoR) - time from the date of first documented response until date of documented progression (as assessed by the investigator, using RECIST 1.1) or death in the absence of disease progression.
Measured: Up to approximately 42 months
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) - number of patients with complete or partial response or with stable disease maintained ≥24 weeks (as assessed by the investigator, using RECIST 1.1) divided by the number of patients in the analysis
Measured: Up to approximately 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 201916 Mar 2026

First posted25 Jun 2019
Study start25 Jun 2019
Primary completion16 Mar 2026 (estimated)
Study completion16 Mar 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Triple Negative Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double-blind Randomised Study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 923 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03997123
Sponsor's protocol ID: D3614C00001
Other IDs: 2018-004687-64, 2018
Acronym: CAPItello-290
Status last verified: Dec 2025
First submitted: 20 May 2019
Last updated: 22 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT03997123
Acronym / sponsor ID: CAPItello-290 / D3614C00001
Conditions: Triple Negative Breast Neoplasms
Keywords: Breast Cancer;, Triple-negative Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 923 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 25 Jun 2019 (actual)
Primary completion: 16 Mar 2026 (estimated)
Study completion: 16 Mar 2026 (estimated)
First posted: 25 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Double-blind Randomised Study

Arm	Type	Receives
Capivasertib + Paclitaxel	Experimental	Drug: Capivasertib, Drug: PaclitaxelPaclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Capivasertib: Oral tablets. 400 mg of Capivasertib (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.
Placebo + Paclitaxel	Placebo comparator	Drug: Paclitaxel, Drug: PlaceboPaclitaxel: Intravenous infusion. 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (22 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CapivasertibAlso: AZD5363400 mg (2 oral tablets) given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Study treatment will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.	Drug	Capivasertib + Paclitaxel
Paclitaxel80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.	Drug	Capivasertib + Paclitaxel, Placebo + Paclitaxel
PlaceboAlso: Placebo tablets to match capivasertibPlacebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week offtreatment within each 28-day treatment cycle	Drug	Placebo + Paclitaxel

Primary outcome

Overall Survival (OS)
Time frame: The time from date of randomisation to the date of death due to any cause up to approximately 42 months
Overall Survival (OS)

9 secondary outcomes

Progression-Free Survival (PFS)
Time frame: The time from date of randomization to the date of progression or death due to any cause, whichever occurs earlier, up to approximately 42 months
Investigator assessment of PFS2
Time frame: Time from randomization to second progression or death due to any cause up to approximately 42 months
Response Rate (ORR)
Time frame: Up to approximately 42 months
Safety and tolerability of drugs by assessment of AEs/SAEs
Time frame: Up to approximately 42 months
Minimum plasma concentration(Cmin), plasma concentration1-2 hours post-dose (C1-2h) and 4 hours post-dose (C4h) during months 1 and 2
Time frame: During months 1 and 2
EORTC QLQ BR23(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module)
Time frame: approximately up to 42 months
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items)
Time frame: approximately up to 42 months
Duration of Response (DoR)
Time frame: Up to approximately 42 months
Clinical Benefit Rate (CBR)
Time frame: Up to approximately 42 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Schmid, MD,PhD,FRCP principal investigator

Centre for Experimental Cancer Medicine (CECM), Barts Cancer Institute

260 sites in 30 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capivasertib and Paclitaxel in people with Triple Negative Breast Neoplasms, run by AstraZeneca at 260 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 260 sites in China, Japan, United States, South Korea, Brazil and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: The time from date of randomisation to the date of death due to any cause up to approximately 42 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03997123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.