New drug cocktail aims to stall breast cancer growth

NCT ID NCT04305496

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding capivasertib to standard fulvestrant therapy can slow cancer growth in people with advanced HR+/HER2- breast cancer. About 818 participants whose cancer worsened after hormone therapy will receive either the combination or a placebo plus fulvestrant. The main goal is to see how long the cancer stays under control.

What this could mean

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

Active substance: capivasertib and fulvestrant
What this could lead to: If successful, this combination could offer a new treatment option to delay cancer progression for people with advanced HR+/HER2- breast cancer.
What could go wrong: This is a late-stage trial, but results are not yet final. The drug may not work for everyone and could cause side effects like diarrhea, rash, or high blood sugar.

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

818 people

The number who actually took part.

Started

Apr 2020

Expected to finish

Jun 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. Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study 2. Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic), as per the American Society of Clinical Oncology and College of American Pathologists guideline recommendations. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor. 3. Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression during or after most recent therapy); locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible) 4. ECOG/WHO PS: 0-1 5. Patients are to have received treatment with an AI (aromatase inhibitor) containing regimen (single agent or in combination) and have: 1. Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an AI, OR 2. Radiological evidence of progression while on prior AI administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy) 6. Patients must have measurable disease according to RECIST 1.1 and/or at least 1 lytic or mixed (lytic + sclerotic) bone lesion that can be assessed by CT or MRI; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible 7. FFPE tumour sample from primary/recurrent cancer for central testing Exclusion Criteria: 1. Symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgement 2. More than 2 lines of endocrine therapy for inoperable locally advanced or metastatic disease 3. More than 1 line of chemotherapy for inoperable locally advanced or metastatic disease. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for advanced breast cancer 4. Prior treatment with any of the following: 1. AKT, PI3K and mTOR inhibitors 2. Fulvestrant, and other SERDs 3. Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation. 4. 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 study treatment initiation. 5. Radiotherapy with a wide field of radiation up to 4 weeks before study treatment initiation (capivasertib/placebo) and/or radiotherapy with a limited field of radiation for palliation up to 2 weeks before study treatment initiation (capivasertib/placebo) 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. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids up to 4 weeks before study treatment initiation 8. Any of the following cardiac criteria: 1. Mean resting QT interval corrected by Fridericia's formula (QTcF) \>470 msec obtained from 3 consecutive ECGs 2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block) 3. Any factors that increase the risk of corrected QT interval (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 4. 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 5. Uncontrolled hypotension - systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg 6. Cardiac ejection fraction outside institutional range of normal or \<50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \[MUGA\] scan if an echocardiogram cannot be performed or is inconclusive) 9. Clinically significant abnormalities of glucose metabolism as defined by any of the following: 1. Patients with diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin treatment 2. HbA1c ≥8.0% (63.9 mmol/mol) 10. Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or LHRH agonist (if applicable) 11. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hormone receptor positive/human epidermal growth factor receptor 2 negative breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

Gilbert, Arizona, 85234, United States
Research Site

Orange, California, 92868, United States
Research Site

San Francisco, California, 94143, United States
Research Site

Whittier, California, 90603, United States
Research Site

Fort Myers, Florida, 33905, United States
Research Site

Jacksonville, Florida, 32224, United States
Research Site

Westwood, Kansas, 66205, United States
Research Site

Baltimore, Maryland, 21201, United States
Research Site

Boston, Massachusetts, 02111-1520, United States
Research Site

Rochester, Minnesota, 55905, United States
Research Site

Kansas City, Missouri, 64132, United States
Research Site

St Louis, Missouri, 63156, United States
Research Site

Paramus, New Jersey, 07652, United States
Research Site

Farmington, New Mexico, 87401, United States
Research Site

Lake Success, New York, 11042, United States
Research Site

New York, New York, 10011, United States
Research Site

Greensboro, North Carolina, 27403, United States
Research Site

Chattanooga, Tennessee, 37404, United States
Research Site

Nashville, Tennessee, 37211, United States
Research Site

Dallas, Texas, 75246, United States
Research Site

Midlothian, Virginia, 23114, United States
Research Site

Puyallup, Washington, 98373, United States
Research Site

Berazategui, B1884BBF, Argentina
Research Site

Buenos Aires, C1125ABD, Argentina
Research Site

La Rioja, 5300, Argentina
Research Site

Rosario, S2000KZE, Argentina
Research Site

Viedma, R8500ACE, Argentina
Research Site

Adelaide, 5000, Australia
Research Site

Ballarat, 3350, Australia
Research Site

Birtinya, 4575, Australia
Research Site

Box Hill, 3128, Australia
Research Site

Concord, 2139, Australia
Research Site

Kurralta Park, 5037, Australia
Research Site

North Sydney, 2060, Australia
Research Site

Orange, 2800, Australia
Research Site

Ringwood East, 3135, Australia
Research Site

South Brisbane, 4101, Australia
Research Site

Waratah, 2298, Australia
Research Site

Wendouree, 3355, Australia
Research Site

Brussels, 1090, Belgium
Research Site

Brussels, 1200, Belgium
Research Site

Charleroi, 6000, Belgium
Research Site

Edegem, 2650, Belgium
Research Site

Namur, 5000, Belgium
Research Site

Wilrijk, 2610, Belgium
Research Site

Winnipeg, Manitoba, R3E 0V9, Canada
Research Site

Kingston, Ontario, K7L 2V7, Canada
Research Site

North York, Ontario, M2K 1E1, Canada
Research Site

Toronto, Ontario, M3M 0B2, Canada
Research Site

Toronto, Ontario, M4N 3M5, Canada
Research Site

Baoding, 071000, China
Research Site

Beijing, 100044, China
Research Site

Beijing, 100191, China
Research Site

Changchun, 130021, China
Research Site

Chongqing, 400030, China
Research Site

Chongqing, 400042, China
Research Site

Dalian, 116011, China
Research Site

Foshan, 528000, China
Research Site

Gongshu District, 310022, China
Research Site

Guangzhou, 510080, China
Research Site

Guangzhou, 510095, China
Research Site

Hangzhou, 310003, China
Research Site

Hangzhou, 310020, China
Research Site

Harbin, 150081, China
Research Site

Hefei, 230001, China
Research Site

Hefei, 230022, China
Research Site

Jinan, 250001, China
Research Site

Linyi, 276001, China
Research Site

Nanchang, 330009, China
Research Site

Nantong, 226001, China
Research Site

Neijiang, 641000, China
Research Site

Shanghai, 200032, China
Research Site

Shanghai, 200127, China
Research Site

Shantou, 515031, China
Research Site

Shenyang, 110001, China
Research Site

Shenyang, 110042, China
Research Site

Wuhan, 430022, China
Research Site

Wuhan, 430030, China
Research Site

Wuhan, 430079, China
Research Site

Zhengzhou, 450008, China
Research Site

Besançon, 25000, France
Research Site

Brest, 29609, France
Research Site

Metz, 57085, France
Research Site

Pierre-Bénite, 69310, France
Research Site

Plerin SUR MER, 22190, France
Research Site

Pringy, 74374, France
Research Site

Rouen, 76038, France
Research Site

Strasbourg, 67065, France
Research Site

Toulouse, 31059, France
Research Site

Dresden, 01307, Germany
Research Site

Erlangen, 91054, Germany
Research Site

Essen, 45130, Germany
Research Site

Frankfurt, 60389, Germany
Research Site

Gelsenkirchen, 45879, Germany
Research Site

Hamburg, 20246, Germany
Research Site

Hamburg, 20249, Germany
Research Site

Hamburg, 20357, Germany
Research Site

Hanover, 30625, Germany
Research Site

Heidelberg, 69120, Germany
Research Site

Kiel, 24105, Germany
Research Site

Mannheim, 68167, Germany
Research Site

Minden, 32429, Germany
Research Site

München, 80637, Germany
Research Site

München, 81377, Germany
Research Site

Münster, 48149, Germany
Research Site

Paderborn, 33161, Germany
Research Site

Potsdam, 14467, Germany
Research Site

Budapest, 1122, Hungary
Research Site

Budapest, 1134, Hungary
Research Site

Debrecen, 4032, Hungary
Research Site

Kecskemét, 6000, Hungary
Research Site

Szekszárd, 7100, Hungary
Research Site

Szolnok, 5000, Hungary
Research Site

Afula, 1834111, Israel
Research Site

Beersheba, 84101, Israel
Research Site

Haifa, 31096, Israel
Research Site

Jerusalem, 91031, Israel
Research Site

Jerusalem, 91120, Israel
Research Site

Kfar Saba, 4428164, Israel
Research Site

Petah Tikva, 49100, Israel
Research Site

Ramat Gan, 52621, Israel
Research Site

Bergamo, 24127, Italy
Research Site

Candiolo, 10060, Italy
Research Site

Catanzaro, 88100, Italy
Research Site

Livorno, 57124, Italy
Research Site

Meldola, 47014, Italy
Research Site

Milan, 20141, Italy
Research Site

Modena, 41124, Italy
Research Site

Naples, 80131, Italy
Research Site

Prato, 59100, Italy
Research Site

Province of Macerata, 62100, Italy
Research Site

Roma, 00128, Italy
Research Site

Chiba, 260-8717, Japan
Research Site

Fukuoka, 811-1395, Japan
Research Site

Fukushima, 960-1295, Japan
Research Site

Hidaka-shi, 350-1298, Japan
Research Site

Hiroshima, 730-8518, Japan
Research Site

Kagoshima, 892-0833, Japan
Research Site

Kitaadachi-gun, 362-0806, Japan
Research Site

Kōtoku, 135-8550, Japan
Research Site

Kumamoto, 860-8556, Japan
Research Site

Kyoto, 606-8507, Japan
Research Site

Matsuyama, 791-0280, Japan
Research Site

Nagoya, 464-8681, Japan
Research Site

Nagoya, 467-8602, Japan
Research Site

Osaka, 540-0006, Japan
Research Site

Osaka, 541-8567, Japan
Research Site

Ota-shi, 373-8550, Japan
Research Site

Sapporo, 003-0804, Japan
Research Site

Sapporo, 060-8638, Japan
Research Site

Shinagawa-ku, 142-8666, Japan
Research Site

Tsu, 514-8507, Japan
Research Site

Yokohama, 241-8515, Japan
Research Site

Arequipa, AREQUIPA01, Peru
Research Site

Lima, LIMA 41, Peru
Research Site

Bydgoszcz, 85-796, Poland
Research Site

Krakow, 31-501, Poland
Research Site

Olsztyn, 10-228, Poland
Research Site

Warsaw, 02-781, Poland
Research Site

Moscow, 111123, Russia
Research Site

Moscow, 115478, Russia
Research Site

Saint Petersburg, 197758, Russia
Research Site

Saint Petersburg, 198255, Russia
Research Site

Samara, 443031, Russia
Research Site

Sochi, 354000, Russia
Research Site

Busan, 49241, South Korea
Research Site

Daegu, 41931, South Korea
Research Site

Goyang-si, 10408, South Korea
Research Site

Incheon, 22332, South Korea
Research Site

Seongnam-si, 13620, South Korea
Research Site

Seoul, 03722, South Korea
Research Site

Seoul, 05505, South Korea
Research Site

Seoul, 135-710, South Korea
Research Site

Seoul, 8308, South Korea
Research Site

Suwon, 16247, South Korea
Research Site

Suwon, 16499, South Korea
Research Site

A Coruña, 15009, Spain
Research Site

Barcelona, 08035, Spain
Research Site

Barcelona, 8003, Spain
Research Site

Córdoba, 14004, Spain
Research Site

Hosp de Llobregat(Barcelona), 08907, Spain
Research Site

Jaén, 23007, Spain
Research Site

La Laguna (Tenerife), 38320, Spain
Research Site

Lleida, 25198, Spain
Research Site

Madrid, 28007, Spain
Research Site

Madrid, 28033, Spain
Research Site

Madrid, 28034, Spain
Research Site

Madrid, 28040, Spain
Research Site

Madrid, 28041, Spain
Research Site

Madrid, 28046, Spain
Research Site

Majadahonda, 28222, Spain
Research Site

Málaga, 29010, Spain
Research Site

Pamplona, 31008, Spain
Research Site

Reus, 43204, Spain
Research Site

Santiago de Compostela, 15706, Spain
Research Site

Seville, 41013, Spain
Research Site

Valencia, 46009, Spain
Research Site

Valencia, 46010, Spain
Research Site

Kaohsiung City, 82445, Taiwan
Research Site

Taichung, 40447, Taiwan
Research Site

Tainan, 70403, Taiwan
Research Site

Tainan, 710, Taiwan
Research Site

Taipei, 10002, Taiwan
Research Site

Taipei, 11217, Taiwan
Research Site

Taipei, 11259, Taiwan
Research Site

Taoyuan, 333, Taiwan
Research Site

Aberdeen, AB25 2ZN, United Kingdom
Research Site

Bournemouth, BH7 7DW, United Kingdom
Research Site

Bristol, BS2 8ED, United Kingdom
Research Site

Cardiff, CF14 2TL, United Kingdom
Research Site

Cheltenham, GL53 7AN, United Kingdom
Research Site

London, NW3 2QG, United Kingdom
Research Site

London, SW3 6JJ, United Kingdom
Research Site

Manchester, M20 4GJ, United Kingdom
Research Site

Sutton, SM25PT, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.