Breast Cancer Clinical Trial

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

Summary

A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292).

View Full Description

Full Description

This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of CDK4/6i + fulvestrant are established separately, the dose and schedule for the triplet combinations (capivasertib + CDK4/6i + fulvestrant) need to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will determine the recommended Phase III doses (RP3D) of the triplet combinations. The Phase III part of the study will evaluate the efficacy, safety and the degree of added benefit of the triplet combinations of capivasertib and fulvestrant with investigator's choice of CDK4/6i (either palbociclib or ribociclib at safe and tolerable doses, once identified) in comparison with a control arm (fulvestrant + investigator's choice of CDK4/6i [palbociclib or ribociclib]) in a ER+ HER2- maC high risk population that did not receive prior endocrine therapy in the advanced setting.

View Eligibility Criteria

Eligibility Criteria

Key inclusion criteria for both phases:

Adult females (pre-/peri-/ and post-menopausal), and adult males.
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.
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.
Adequate organ and bone marrow functions.
Consent to provide a mandatory FFPE tumour sample.

Key inclusion criteria only for phase III:

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.
Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA/AKT1/PTEN status.
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.
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:

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.
Radiotherapy within 2 weeks prior to study treatment initiation.
Major surgery or significant traumatic injury within 4 weeks of the first dose of study treatment.
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.
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.

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)

uncontrolled or high grade or symptomatic arrhythmia and atrial fibrillation

Any of these clinically significant abnormalities of glucose metabolism at screening:

. diabetes mellitus type I or type II requiring insulin treatment
. Glycated haemoglobin (HbA1c) ≥ 8.0% (63.9 mmol/mol)
Previous allogeneic bone marrow transplant or solid organ transplant.

Key exclusion criteria for the phase III only:

Any prior treatment with, AKT, PI3K or mTOR inhibitors.
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).
More than 1 line of chemotherapy for metastatic disease

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

895

Study ID:

NCT04862663

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 216 Locations for this study

See Locations Near You

Research Site
Tucson Arizona, 85719, United States
Research Site
Los Angeles California, 90033, United States
Research Site
Los Angeles California, 90048, United States
Research Site
Newport Beach California, 92663, United States
Research Site
San Francisco California, 94158, United States
Research Site
Santa Barbara California, 93105, United States
Research Site
Santa Rosa California, 92805, United States
Research Site
Aurora Colorado, 80045, United States
Research Site
New Haven Connecticut, 06510, United States
Research Site
Newark Delaware, 19713, United States
Research Site
Quincy Illinois, 62305, United States
Research Site
Fort Wayne Indiana, 46804, United States
Research Site
Louisville Kentucky, 40202, United States
Research Site
Louisville Kentucky, 40202, United States
Research Site
Covington Louisiana, 70433, United States
Research Site
Annapolis Maryland, 21401, United States
Research Site
Baltimore Maryland, 21202, United States
Research Site
Baltimore Maryland, 21229, United States
Research Site
Boston Massachusetts, 02215, United States
Research Site
Detroit Michigan, 48236, United States
Research Site
Grand Rapids Michigan, 49503, United States
Research Site
Hannibal Missouri, 63401, United States
Research Site
Saint Louis Missouri, 63110, United States
Research Site
Omaha Nebraska, 68130, United States
Research Site
Camden New Jersey, 08103, United States
Research Site
New York New York, 10016, United States
Research Site
New York New York, 10065, United States
Research Site
Durham North Carolina, 27710, United States
Research Site
Gresham Oregon, 97030, United States
Research Site
Philadelphia Pennsylvania, 19104, United States
Research Site
Pittsburgh Pennsylvania, 15213, United States
Research Site
York Pennsylvania, 17403, United States
Research Site
Providence Rhode Island, 02903, United States
Research Site
Nashville Tennessee, 37203, United States
Research Site
Dallas Texas, 75246, United States
Research Site
Fort Worth Texas, 76104, United States
Research Site
Houston Texas, 77030, United States
Research Site
San Antonio Texas, 78229, United States
Research Site
San Antonio Texas, 78240, United States
Research Site
Falls Church Virginia, 22042, United States
Research Site
Leesburg Virginia, 20176, United States
Research Site
Midlothian Virginia, 23114, United States
Research Site
Midlothian Virginia, 23114, United States
Research Site
Norfolk Virginia, 23502, United States
Research Site
Tacoma Washington, 98405, United States
Research Site
Buenos Aires , 1439, Argentina
Research Site
Buenos Aires , C1125, Argentina
Research Site
Caba , 1414, Argentina
Research Site
Caba , 1425, Argentina
Research Site
Caba , C1425, Argentina
Research Site
Chivilcoy , B6620, Argentina
Research Site
Rosario , 2000, Argentina
Research Site
Santa Fe , S2002, Argentina
Research Site
Darlinghurst , 2010, Australia
Research Site
Miranda , 2228, Australia
Research Site
Nedlands , 6009, Australia
Research Site
Perth , 6009, Australia
Research Site
Wahroonga , 2076, Australia
Research Site
Waratah , 2298, Australia
Research Site
Brasschaat , 2930, Belgium
Research Site
Bruxelles , 1200, Belgium
Research Site
Edegem , 2650, Belgium
Research Site
Haine-Saint-Paul , 7100, Belgium
Research Site
Leuven , 3000, Belgium
Research Site
Alfenas , 37130, Brazil
Research Site
Blumenau , 89010, Brazil
Research Site
Natal , 59075, Brazil
Research Site
Porto Alegre , 90035, Brazil
Research Site
Porto Velho , 76834, Brazil
Research Site
São Paulo , 04014, Brazil
Research Site
Taubaté , 12030, Brazil
Research Site
Teresina , 64049, Brazil
Research Site
Vitoria , 29043, Brazil
Research Site
Abbotsford British Columbia, V2S0C, Canada
Research Site
Kelowna British Columbia, V1Y 5, Canada
Research Site
Winnipeg Manitoba, R3E 0, Canada
Research Site
Moncton New Brunswick, E1C 6, Canada
Research Site
Halifax Nova Scotia, B3H 1, Canada
Research Site
Brampton Ontario, L6R 3, Canada
Research Site
Ottawa Ontario, K1H 8, Canada
Research Site
Sault Ste. Marie Ontario, P6A 2, Canada
Research Site
Toronto Ontario, M5B 1, Canada
Research Site
Sherbrooke Quebec, J1H 5, Canada
Research Site
Chicoutimi , G7H 5, Canada
Research Site
Montreal , H3T 1, Canada
Research Site
Beijing , 10003, China
Research Site
Beijing , 10004, China
Research Site
Beijing , 10019, China
Research Site
Beijing , 10021, China
Research Site
Bengbu , 23306, China
Research Site
Changchun , 13000, China
Research Site
Changsha , 41001, China
Research Site
Chengdu , 61004, China
Research Site
Chongqing , 40004, China
Research Site
Guangzhou , 51006, China
Research Site
Guangzhou , 51006, China
Research Site
Guangzhou , 51008, China
Research Site
Hangzhou , 31000, China
Research Site
Hangzhou , 31001, China
Research Site
Hangzhou , 31002, China
Research Site
Hefei , 23003, China
Research Site
Jinan , 25000, China
Research Site
Nanchang , 33000, China
Research Site
Nanchang , 33000, China
Research Site
Nanjing , 21002, China
Research Site
Nanning , 53002, China
Research Site
Shandong , , China
Research Site
Shanghai , 20003, China
Research Site
Shenyang , 11000, China
Research Site
Shenyang , 11001, China
Research Site
Urumqi , 83000, China
Research Site
Urumqi , 83000, China
Research Site
Wuhan , 43006, China
Research Site
Xi'an , 71006, China
Research Site
Xiangyang City , 44100, China
Research Site
Xian , 71010, China
Research Site
Xuzhou , 22100, China
Research Site
Zhengzhou , 45000, China
Research Site
Aalborg , 9000, Denmark
Research Site
Aarhus N , 8200, Denmark
Research Site
Hillerød , 3400, Denmark
Research Site
Odense C , 5000, Denmark
Research Site
Bobigny , 93000, France
Research Site
Clermont Ferrand , 63011, France
Research Site
Limoges , 87042, France
Research Site
Lyon , 69008, France
Research Site
Plerin , 22190, France
Research Site
Rouen , 76021, France
Research Site
St Herblain , 44805, France
Research Site
Villejuif , 94805, France
Research Site
Augsburg , 86150, Germany
Research Site
Berlin , 10967, Germany
Research Site
Berlin , 13125, Germany
Research Site
Bottrop , 46236, Germany
Research Site
Dresden , 01307, Germany
Research Site
Erlangen , 91054, Germany
Research Site
Frankfurt am Main , 65929, Germany
Research Site
Freiburg , 79106, Germany
Research Site
Georgsmarienhütte , 49124, Germany
Research Site
Hamburg , 20357, Germany
Research Site
Hannover , 30625, Germany
Research Site
Heilbronn , 74078, Germany
Research Site
Kiel , 24105, Germany
Research Site
Leipzig , 04103, Germany
Research Site
Mannheim , 68167, Germany
Research Site
Mönchengladbach , 41061, Germany
Research Site
Münster , 48149, Germany
Research Site
Regensburg , 93053, Germany
Research Site
Stade , 21680, Germany
Research Site
Trier , 54290, Germany
Research Site
Ulm , 89075, Germany
Research Site
Bangalore , 56000, India
Research Site
Jaipur , 30201, India
Research Site
JAipur , 30202, India
Research Site
Mohali , 16005, India
Research Site
Mysuru , 57001, India
Research Site
Nagpur , 44000, India
Research Site
New Delhi , 11007, India
Research Site
New Delhi , 11007, India
Research Site
Pondicherry , 60500, India
Research Site
Vadodara , 39176, India
Research Site
Varanasi , 22100, India
Research Site
Milan , 20141, Italy
Research Site
Misterbianco , 95045, Italy
Research Site
Chuo-ku , 104-0, Japan
Research Site
Koto-ku , 135-8, Japan
Research Site
Goyang-si , 10408, Korea, Republic of
Research Site
Seoul , 02841, Korea, Republic of
Research Site
Seoul , 03080, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 06273, Korea, Republic of
Research Site
Seoul , 06351, Korea, Republic of
Research Site
Seoul , 5505, Korea, Republic of
Research Site
George Town , 10350, Malaysia
Research Site
Kuala Lumpur , 50586, Malaysia
Research Site
Kuala Lumpur , 59100, Malaysia
Research Site
Kuala Lumpur , 59100, Malaysia
Research Site
Kuching , 93586, Malaysia
Research Site
Pulau Pinang , 10450, Malaysia
Research Site
Selangor , 46050, Malaysia
Research Site
Selangor , 62250, Malaysia
Research Site
Bydgoszcz , 85-79, Poland
Research Site
Kraków , 31-50, Poland
Research Site
Lodz , 91-21, Poland
Research Site
Lublin , 20-09, Poland
Research Site
Warszawa , 02-78, Poland
Research Site
Warszawa , 02-78, Poland
Research Site
Barcelona , 8035, Spain
Research Site
Granada , 18014, Spain
Research Site
Lérida , 25198, Spain
Research Site
Madrid , 28034, Spain
Research Site
Madrid , 28040, Spain
Research Site
Madrid , 28046, Spain
Research Site
Málaga , 29010, Spain
Research Site
Pamplona , 31008, Spain
Research Site
Santiago de Compostela , 15706, Spain
Research Site
Lund , 221 8, Sweden
Research Site
Solna , 17176, Sweden
Research Site
Växjö , 35185, Sweden
Research Site
Kaohsiung , 80756, Taiwan
Research Site
Kaohsiung , 83301, Taiwan
Research Site
Taichung , , Taiwan
Research Site
Tainan , 704, Taiwan
Research Site
Taipei , 10002, Taiwan
Research Site
Taipei , 10449, Taiwan
Research Site
Taoyuan , 333, Taiwan
Research Site
Bangkok , 10210, Thailand
Research Site
Bangkok , 10330, Thailand
Research Site
Bangkok , 10400, Thailand
Research Site
Bangkok , 10400, Thailand
Research Site
Bangkok , 10700, Thailand
Research Site
Chiang Mai , 50200, Thailand
Research Site
Dusit , 10300, Thailand
Research Site
Hat Yai , 90110, Thailand
Research Site
Khon Kaen , 40002, Thailand
Research Site
Lampang , 52000, Thailand
Research Site
Ratchathewi , 10400, Thailand
Research Site
Ankara , 6100, Turkey
Research Site
Antalya , 07070, Turkey
Research Site
Goztepe Istanbul , , Turkey
Research Site
Karsiyaka , 35575, Turkey
Research Site
Kayseri , 38039, Turkey
Research Site
Malatya , 44280, Turkey
Research Site
Samsun , , Turkey
Research Site
Derry , BT47 , United Kingdom
Research Site
Guildford , CU2 7, United Kingdom
Research Site
London , SE1 9, United Kingdom
Research Site
Taunton , TA1 5, United Kingdom
Research Site
York , YO21 , United Kingdom
Research Site
Hanoi , 10000, Vietnam
Research Site
Ho Chi Minh city , 70000, Vietnam
Research Site
Ho Chi Minh city , 70000, Vietnam
Research Site
Ho Chi Minh , 70000, Vietnam
Research Site
Vinh , 46000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

895

Study ID:

NCT04862663

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.