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New combo aims to stall advanced breast cancer

NCT ID NCT04862663

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 4 times

Summary

This study tests whether adding the experimental drug capivasertib to standard hormone therapy and CDK4/6 inhibitors can delay cancer growth in people with advanced HR+/HER2- breast cancer that cannot be removed by surgery or has spread. About 895 adults whose cancer has not responded to prior treatment will be randomly assigned to receive either the new combination or standard therapy alone. The main goal is to see how long the cancer stays under control and to monitor side effects.

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

893 people

The number who actually took part.

Started

May 2021

Expected to finish

Aug 2029

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 99 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.

Key inclusion criteria for both phases: 1. Adult females (pre-/peri-/ and post-menopausal), and adult males. 2. Histologically confirmed HR+/ HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) per the American Society of Clinical Oncology and College of American Pathologists guideline. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor. 3. Eligible for fulvestrant therapy and at least one of the following: palbociclib, ribociclib, or abemaciclib, as per local investigator assessment. Previous tolerance to specific CDK4/6 inhibitors and dose levels required. 4. Adequate organ and bone marrow functions. 5. Consent to provide a mandatory FFPE tumour sample. Key inclusion criteria only for phase III: 1. Previous treatment with an ET (tamoxifen, AI, or oral SERD) as a single agent or in combination, with radiological evidence of breast cancer recurrence or progression while on, or within 12 months of, completing a (neo)adjuvant ET regimen. 2. Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA/AKT1/PTEN status. 3. Be eligible for fulvestrant and at least one out of palbociclib or ribociclib (depending on the available CDK4/6i options at time of enrolment), as per local investigator assessment. 4. Have measurable lesion(s) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) or, in the absence of measurable disease, lytic or mixed bone lesions that can be assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Key exclusion criteria for both phases: 1. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. 2. Radiotherapy within 2 weeks prior to study treatment initiation. 3. Major surgery or significant traumatic injury within 4 weeks of the first dose of study treatment. 4. Persistent toxicities (CTCAE Grade \>1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss or peripheral sensory neuropathy) after consultation with the AstraZeneca study physician. 5. Spinal cord compression, brain metastases or leptomeningeal metastases unless these lesions are definitively treated (eg. radiotherapy, surgery) and clinically stable off steroids for management of symptoms for at least 4 weeks prior to study treatment initiation. 6. Any of the following cardiac criteria at screening: (a). Mean resting corrected QT interval (QTcF): (i) Participants to be treated with palbociclib:: QTcF ≥ 470 ms obtained from the average of 3 consecutive (triplicate) ECGs (ii) Participants to be treated with ribociclib: QTcF ≥ 450 ms obtained from the average of 3 consecutive (triplicate) ECGs (iii) Participants to be treated with abemaciclib (Phase Ib only): QTcF ≥ 470 ms obtained from the average of 3 consecutive (triplicate) ECGs (b). Any clinically important abnormalities in cardiac rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block) (c). Any factors that increase the risk of QTc prolongation or risk of arrhythmic events (d). Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥ 2 (e). Uncontrolled hypotension (f) uncontrolled hypertension (g). Cardiac ejection fraction outside institutional range of normal or \< 50% (whichever is higher) 7. uncontrolled or high grade or symptomatic arrhythmia and atrial fibrillation 8. Any of these clinically significant abnormalities of glucose metabolism at screening: 1. . diabetes mellitus type I or type II requiring insulin treatment 2. . Glycated haemoglobin (HbA1c) ≥ 8.0% (63.9 mmol/mol) 9. Previous allogeneic bone marrow transplant or solid organ transplant. Key exclusion criteria for the phase III only: 1. Any prior treatment with, AKT, PI3K or mTOR inhibitors. 2. Prior treatment with CDK4/6 inhibitors in the metastatic setting (prior CDK4/6 inhibitors permitted in the adjuvant setting provided there was a CDK4/6i treatment free interval of at least 12 months). 3. More than 1 line of chemotherapy for metastatic disease. 4. Any line of endocrine-based therapy for inoperable locally advanced or metastatic disease.

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

Locally advanced (inoperable) or metastatic breast cancer

Contacts and locations

Locations

  • Research Site

    Tucson, Arizona, 85719, United States

  • Research Site

    Fountain Valley, California, 92708, United States

  • Research Site

    Glendale, California, 91204, United States

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    Los Angeles, California, 90033, United States

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    Napa, California, 94558, United States

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    San Francisco, California, 94158, United States

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    Santa Rosa, California, 92805, United States

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    Aurora, Colorado, 80045, United States

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    New Haven, Connecticut, 06510, United States

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    Newark, Delaware, 19713, United States

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    Louisville, Kentucky, 40202, United States

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    Annapolis, Maryland, 21401, United States

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    Boston, Massachusetts, 02215, United States

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    Detroit, Michigan, 48236, United States

  • Research Site

    Grand Rapids, Michigan, 49503, United States

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    Hannibal, Missouri, 63401, United States

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    St Louis, Missouri, 63110, United States

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    Omaha, Nebraska, 68130, United States

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    Camden, New Jersey, 08103, United States

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    Mineola, New York, 11501, United States

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    New York, New York, 10016, United States

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    New York, New York, 10065, United States

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    Gresham, Oregon, 97030, United States

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    Philadelphia, Pennsylvania, 19104, United States

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    Pittsburgh, Pennsylvania, 15213, United States

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    York, Pennsylvania, 17403, United States

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    Greenville, South Carolina, 29607, United States

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    Chattanooga, Tennessee, 37404, United States

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    Nashville, Tennessee, 37203, United States

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    Dallas, Texas, 75246, United States

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    Houston, Texas, 77030, United States

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    Irving, Texas, 75063, United States

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    San Antonio, Texas, 78229, United States

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    San Antonio, Texas, 78240, United States

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    Salt Lake City, Utah, 84106, United States

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    Fairfax, Virginia, 22031, United States

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    Falls Church, Virginia, 22042, United States

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    Midlothian, Virginia, 23114, United States

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    Norfolk, Virginia, 23502, United States

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    Tacoma, Washington, 98405, United States

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    Buenos Aires, 1439, Argentina

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    CABA, 1414, Argentina

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    CABA, 1425, Argentina

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    CABA, C1113AAE, Argentina

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    CABA, C1425, Argentina

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    Chivilcoy, B6620LUD, Argentina

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    Rosario, 2000, Argentina

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    Darlinghurst, 2010, Australia

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    Nedlands, 6009, Australia

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    Waratah, 2298, Australia

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    Brasschaat, 2930, Belgium

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    Brussels, 1200, Belgium

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    Edegem, 2650, Belgium

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    Haine-Saint-Paul, 7100, Belgium

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    Leuven, 3000, Belgium

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    Alfenas, 37130-000, Brazil

  • Research Site

    Blumenau, 89010-340, Brazil

  • Research Site

    Natal, 59075-740, Brazil

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    Porto Alegre, 90035-903, Brazil

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    Porto Velho, 76834-899, Brazil

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    São Paulo, 04014-002, Brazil

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    Taubaté, 12030-200, Brazil

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    Teresina, 64049-200, Brazil

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    Vitória, 29043-260, Brazil

  • Research Site

    Abbotsford British Columbia, British Columbia, V2S0C2, Canada

  • Research Site

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Research Site

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Research Site

    Brampton, Ontario, L6R 3J7, Canada

  • Research Site

    Ottawa, Ontario, K1H 8L6, Canada

  • Research Site

    Toronto, Ontario, M5B 1W8, Canada

  • Research Site

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Research Site

    Chicoutimi, G7H 5H6, Canada

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    Montreal, H3T 1E2, Canada

  • Research Site

    Beijing, 100039, China

  • Research Site

    Beijing, 100044, China

  • Research Site

    Beijing, 100191, China

  • Research Site

    Beijing, 100210, China

  • Research Site

    Bengbu, 233004, China

  • Research Site

    Changchun, 130000, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Chongqing, 400042, China

  • Research Site

    Guangzhou, 510060, China

  • Research Site

    Guangzhou, 510062, China

  • Research Site

    Hangzhou, 31000, China

  • Research Site

    Hangzhou, 310022, China

  • Research Site

    Hefei, 230031, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Nanchang, 330009, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Nanning, 530021, China

  • Research Site

    Shandong, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenyang, 110001, China

  • Research Site

    Shenyang, 110016, China

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    Ürümqi, 830000, China

  • Research Site

    Wuhan, 430060, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Xuzhou, 221009, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Aalborg, 9000, Denmark

  • Research Site

    Aarhus N, 8200, Denmark

  • Research Site

    Hillerød, 3400, Denmark

  • Research Site

    Odense, 5000, Denmark

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    Bobigny, 93000, France

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    Limoges, 87042, France

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    Lyon, 69008, France

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    Plérin, 22190, France

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    Rouen, 76021, France

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    Saint-Herblain, 44805, France

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    Villejuif, 94805, France

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    Augsburg, 86150, Germany

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    Dresden, 01307, Germany

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    Erlangen, 91054, Germany

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    Essen, 45136, Germany

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    Frankfurt am Main, 65929, Germany

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    Freiburg im Breisgau, 79106, Germany

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    Georgsmarienhütte, 49124, Germany

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    Hanover, 30625, Germany

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    Heilbronn, 74078, Germany

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    Kiel, 24105, Germany

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    Leipzig, 04103, Germany

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    Mannheim, 68167, Germany

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    Mönchengladbach, 41061, Germany

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    Regensburg, 93053, Germany

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    Ulm, 89075, Germany

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    Bangalore, 560004, India

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    Mohali, 160055, India

  • Research Site

    Mysuru, 570017, India

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    Nagpur, 440001, India

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    New Delhi, 110075, India

  • Research Site

    New Delhi, 110076, India

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    Vadodara, 391760, India

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    Varanasi, 221005, India

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    Bologna, 40138, Italy

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    Florence, 50141, Italy

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    Misterbianco, 95045, Italy

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    Naples, 80131, Italy

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    Padova, 35128, Italy

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    Prato, 59100, Italy

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    Roma, 00168, Italy

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    Chiba, 260-8717, Japan

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    Chūōku, 104-0045, Japan

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    Chūōku, 104-8560, Japan

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    Hidaka-shi, 350-1298, Japan

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    Hiroshima, 730-8518, Japan

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    Isehara-shi, 259-1193, Japan

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    Kagoshima, 892-0833, Japan

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    Kōtoku, 135-8550, Japan

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    Kyoto, 606-8507, Japan

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    Matsuyama, 791-0280, Japan

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    Naha, 901-0154, Japan

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    Osaka, 541-8567, Japan

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    Ota-shi, 373-8550, Japan

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    Sapporo, 060-8638, Japan

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    Sendai, 980-8574, Japan

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    Shimotsuke-shi, 329-0498, Japan

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    Shinagawa-ku, 142-8666, Japan

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    Shinjuku-ku, 162-8655, Japan

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    Suita-shi, 565-0871, Japan

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    Takasaki-shi, 370-0829, Japan

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    Tsu, 514-8507, Japan

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    Yokohama, 241-8515, Japan

  • Research Site

    George Town, 10350, Malaysia

  • Research Site

    Kuala Lumpur, 50586, Malaysia

  • Research Site

    Kuala Lumpur, 59100, Malaysia

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    Kuala Selangor, 46050, Malaysia

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    Kuala Selangor, 62250, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

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    Pulau Pinang, 10450, Malaysia

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    Bydgoszcz, 85-796, Poland

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    Krakow, 31-501, Poland

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    Warsaw, 02-781, Poland

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    Goyang-si, 10408, South Korea

  • Research Site

    Seoul, 02841, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06273, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 5505, South Korea

  • Research Site

    Barcelona, 8035, Spain

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    Granada, 18014, Spain

  • Research Site

    Lleida, 25198, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Madrid, 28040, Spain

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    Málaga, 29010, Spain

  • Research Site

    Pamplona, 31008, Spain

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    Santiago de Compostela, 15706, Spain

  • Research Site

    Lund, 221 85, Sweden

  • Research Site

    Solna, 17176, Sweden

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    Kaohsiung City, 80756, Taiwan

  • Research Site

    Kaohsiung City, 83301, Taiwan

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    Taichung, 40705, Taiwan

  • Research Site

    Taichung, Taiwan

  • Research Site

    Tainan, 704, Taiwan

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    Taipei, 10002, Taiwan

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    Taipei, 10449, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10210, Thailand

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    Bangkok, 10330, Thailand

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    Bangkok, 10400, Thailand

  • Research Site

    Bangkok, 10700, Thailand

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    Chiang Mai, 50200, Thailand

  • Research Site

    Dusit, 10300, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

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    Lampang, 52000, Thailand

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    Ratchathewi, 10400, Thailand

  • Research Site

    Ankara, 6100, Turkey (Türkiye)

  • Research Site

    Antalya, 07070, Turkey (Türkiye)

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    Cordaleo, 35575, Turkey (Türkiye)

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    Goztepe Istanbul, Turkey (Türkiye)

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    Malatya, 44280, Turkey (Türkiye)

  • Research Site

    Samsun, 55200, Turkey (Türkiye)

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    Guildford, CU2 7XX, United Kingdom

  • Research Site

    London, SE1 9RT, United Kingdom

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    Londonderry, BT47 6SB, United Kingdom

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    Taunton, TA1 5DA, United Kingdom

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    York, YO21 8HE, United Kingdom

  • Research Site

    Can Tho, 900000, Vietnam

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    Hanoi, 100000, Vietnam

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    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Ho Chi Minh City, 70000, Vietnam

  • Research Site

    Hồ Chí Minh, 700000, Vietnam

  • Research Site

    Vinh, 460000, Vietnam

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