New hope for Hard-to-Treat breast cancer: targeted drug combo in final testing

NCT ID NCT03997123

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding capivasertib (a targeted drug) to standard chemotherapy (paclitaxel) helps people with advanced triple-negative breast cancer live longer. About 923 participants receive either the combination or a placebo plus chemotherapy. The study is no longer recruiting, and results will show if the new combo improves survival and delays cancer growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Capivasertib (a targeted cancer drug) combined with paclitaxel (a chemotherapy drug)
What this could lead to: If successful, this combination could become a new first-line treatment option for people with advanced triple-negative breast cancer, potentially improving survival.
What could go wrong: This is a late-stage trial, but results are not yet available. The drug may not improve survival significantly, and side effects from the combination could be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

923 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed TNBC from most recently collected tumour tissue sample 2. 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) 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 Exclusion Criteria: 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 3. 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 * 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) 5. Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5 6. With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment 7. 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). 8. 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) 9. Inadequate bone marrow reserve or organ function at screening 10. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding

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Conditions

The condition(s) this trial relates to.

breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple negative breast neoplasms

Contacts and locations

Locations

Research Site

Whittier, California, 90602, United States
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Whittier, California, 90603, United States
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Fort Myers, Florida, 33901, United States
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Miami, Florida, 33136, United States
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St. Petersburg, Florida, 33705, United States
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Tampa, Florida, 33612, United States
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Chicago, Illinois, 60637, United States
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Westwood, Kansas, 66205, United States
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Silver Spring, Maryland, 20910, United States
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Detroit, Michigan, 48202, United States
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Nyack, New York, 10960, United States
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Cincinnati, Ohio, 45220, United States
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Columbus, Ohio, 43210, United States
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Harrisburg, Pennsylvania, 17109, United States
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Philadelphia, Pennsylvania, 19104, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78758, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77090, United States
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San Antonio, Texas, 78229, United States
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Fairfax, Virginia, 22031, United States
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Buenos Aires, C1125ABD, Argentina
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CABA, 1414, Argentina
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CABA, C1012AAR, Argentina
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CABA, C1019ABS, Argentina
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CABA, C1426ANZ, Argentina
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Ciudad Autonomade Buenos Aires, 1426, Argentina
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La Plata, 1900, Argentina
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Mar del Plata, 7600, Argentina
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Rosario, 2000, Argentina
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Barretos, 14784-400, Brazil
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Florianópolis, 88034-000, Brazil
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Goiânia, 74605-070, Brazil
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Londrina, 86015-520, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90110-270, Brazil
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Porto Alegre, 90619-900, Brazil
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Rio de Janeiro, 20560-120, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01317-000, Brazil
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São Paulo, 04014-002, Brazil
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Victoria, British Columbia, V8R 6V5, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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North York, Ontario, M2K 1E1, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Beijing, 100021, China
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Beijing, China
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Changchun, 130021, China
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Changsha, 410013, China
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Changsha, 410078, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Foshan, 528000, China
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Guangzhou, 510060, China
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Guiyang, 550004, China
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Haikou, 570311, China
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Hangzhou, 310003, China
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Hangzhou, 310009, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230001, China
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Jinan, 250117, China
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Linyi, 276000, China
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Nanchang, 330009, China
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Nanjing, 210029, China
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Nanyang, 473009, China
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Shanghai, 200032, China
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Shenyang, 110001, China
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Shenyang, 110042, China
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Ürümqi, 830000, China
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Wenzhou, 325000, China
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Wuhan, 430030, China
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Wuhan, China
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Xi'an, 710061, China
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Zhengzhou, 450000, China
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Floridablanca, 681004, Colombia
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Ibague, 730006, Colombia
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Medellín, 5001000, Colombia
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Montería, 23001, Colombia
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Valledupar, 200001, Colombia
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Hradec Králové, 500 05, Czechia
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Olomouc, 77900, Czechia
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Prague, 100 34, Czechia
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Prague, 128 08, Czechia
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Brest, 29609, France
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Lyon, 69008, France
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Marseille, 13009, France
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Montpellier, 34070, France
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Nice, 6189, France
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Paris, 75020, France
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Saint-Herblain, 44805, France
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Villejuif, 94805, France
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Athens, 115 22, Greece
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Athens, 11528, Greece
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Athens, 12462, Greece
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Heraklion, 71110, Greece
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Thessaloniki, 54645, Greece
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Budapest, 1062, Hungary
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Budapest, 1097, Hungary
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Budapest, 1106, Hungary
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Győr, 9024, Hungary
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Nyíregyháza, 4400, Hungary
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Szekszárd, 7100, Hungary
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Bangalore, 560052, India
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Bangalore, 560064, India
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Gurgaon, 122001, India
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Kolkata, 700054, India
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Kolkata, 700160, India
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Mumbai, 400012, India
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Mysuru, 570017, India
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Nagpur, 440001, India
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Nagpur, 440012, India
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Nashik, 422002, India
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New Delhi, 110085, India
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New Delhi, 11029, India
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Bunkyō City, 113-8431, Japan
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Fukuoka, 811-1395, Japan
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Hidaka-shi, 350-1298, Japan
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Hiroshima, 730-8518, Japan
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Kagoshima, 892-0833, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Niigata, 951-8566, Japan
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Osaka, 540-0006, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-8574, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 162-8655, Japan
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Sunto-gun, 411-8777, Japan
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Takasaki-shi, 370-0829, Japan
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Tsu, 514-8507, Japan
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Tsukuba, 305-8576, Japan
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Yokohama, 241-8515, Japan
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 62250, Malaysia
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Kuching, 93586, Malaysia
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Aguascalientes, 20230, Mexico
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Estado de México, 50080, Mexico
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Guadalajara, 44680, Mexico
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México, 06725, Mexico
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Monterrey, 64710, Mexico
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Tuxtla Gutiérrez, 29038, Mexico
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Tuxtla Gutiérrez, 29090, Mexico
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Arequipa, AREQUIPA01, Peru
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Callao, CALLAO 02, Peru
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Lima, 0051, Peru
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Lima, 15033, Peru
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Lima, L27, Peru
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Lima, LIMA 34, Peru
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Bacolod, 6100, Philippines
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Baguio City, 2600, Philippines
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Cagayan de Oro, 9000, Philippines
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Cebu City, 6000, Philippines
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Davao City, 8000, Philippines
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Iloilo City, 5000, Philippines
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Iloilo City, Philippines
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Las Piñas, 1740, Philippines
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Legaspi, 4500, Philippines
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Manila, 1000, Philippines
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Quezon City, 1112, Philippines
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San Juan City, 1500, Philippines
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Bydgoszcz, 85-796, Poland
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Konin, 62-500, Poland
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Poznan, 61-866, Poland
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Racibórz, 47-400, Poland
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Radom, 26-600, Poland
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Tomaszów Mazowiecki, 97-200, Poland
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Warsaw, 01-748, Poland
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Wroclaw, 53-413, Poland
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Lisbon, 1099-023, Portugal
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Lisbon, 1400-038, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4099-001, Portugal
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Arkhangelsk, 163045, Russia
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Moscow, 121205, Russia
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Moscow, 121467, Russia
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Saint Petersburg, 190103, Russia
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Saint Petersburg, 197758, Russia
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Volgograd, 400138, Russia
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Yaroslavl, 150054, Russia
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Dammam, 31444, Saudi Arabia
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Jeddah, 22384, Saudi Arabia
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Mecca, 24246, Saudi Arabia
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Riyadh, 11426, Saudi Arabia
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Riyadh, 11525, Saudi Arabia
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Riyadh, 12311, Saudi Arabia
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Riyadh, 12713, Saudi Arabia
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Bratislava, 833 01, Slovakia
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Johannesburg, 2193, South Africa
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Johannesburg, 2196, South Africa
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Pretoria, 0002, South Africa
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Pretoria, 0084, South Africa
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Busan, 602-739, South Korea
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Cheonan-si, 31151, South Korea
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Cheongju-si, 28644, South Korea
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Incheon, 21565, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Badalona, 08916, Spain
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Barcelona, 08025, Spain
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Barcelona, 8035, Spain
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Hospitalet deLlobregat, 08907, Spain
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Jaén, 23007, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Seville, 41009, Spain
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Valencia, 46026, Spain
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Zaragoza, 50009, Spain
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Gothenburg, 413 45, Sweden
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Lund, 221 85, Sweden
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Stockholm, 118 83, Sweden
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Hsinchu, 300, Taiwan
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Hualien City, 97002, Taiwan
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Kaohsiung City, 82445, Taiwan
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Kaohsiung City, 83301, Taiwan
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Tainan, 710, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 104, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Taipei, 235, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Mueang, 50200, Thailand
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06520, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Malatya, 44280, Turkey (Türkiye)
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Mersin, 33070, Turkey (Türkiye)
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Edinburgh, EH4 2XU, United Kingdom
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London, E1 1BB, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE1 9RT, United Kingdom
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Sheffield, S10 2SJ, United Kingdom
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Surrey, GU2 7XX, United Kingdom
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York, YO31 8HE, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, Vietnam

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