Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
NCT ID: NCT04862663
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
895 participants
INTERVENTIONAL
2021-05-10
2029-08-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Phase III: open-label, randomised, recruiting approx. 794 participants.
TREATMENT
NONE
Study Groups
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Capivasertib Plus Palbociclib and Fulvestrant
Capivasertib Plus Palbociclib and Fulvestrant (Ph 1b)
Capivasertib
Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion
Fulvestrant
Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter
Palbociclib
Phase Ib: 100 mg/ 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose of 125 mg.
Capivasertib Plus Ribociclib and Fulvestrant
Capivasertib Plus Ribociclib and Fulvestrant (Ph 1b)
Ribociclib
Phase Ib: 200 mg/ 400 mg/ 600 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose confirmed in the phase 1b portion.
Capivasertib Plus Abemaciclib and Fulvestrant
Capivasertib Plus Abemaciclib and Fulvestrant (Ph 1b)
Abemaciclib
Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle
Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib)
Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III)
Capivasertib
Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion
Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib)
Fulvestrant and investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III)
Fulvestrant
Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter
Interventions
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Capivasertib
Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion
Fulvestrant
Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter
Palbociclib
Phase Ib: 100 mg/ 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose of 125 mg.
Ribociclib
Phase Ib: 200 mg/ 400 mg/ 600 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose confirmed in the phase 1b portion.
Abemaciclib
Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle
Eligibility Criteria
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Inclusion Criteria
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.
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).
Exclusion Criteria
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.
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.
18 Years
99 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Tucson, Arizona, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Napa, California, United States
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Newport Beach, California, United States
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San Francisco, California, United States
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Santa Barbara, California, United States
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Santa Rosa, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Quincy, Illinois, United States
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Fort Wayne, Indiana, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Covington, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Hannibal, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Camden, New Jersey, United States
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Brooklyn, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Gresham, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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York, Pennsylvania, United States
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Providence, Rhode Island, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Falls Church, Virginia, United States
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Leesburg, Virginia, United States
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Midlothian, Virginia, United States
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Norfolk, Virginia, United States
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Tacoma, Washington, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Chivilcoy, , Argentina
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Rosario, , Argentina
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Santa Fe, , Argentina
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Darlinghurst, , Australia
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Miranda, , Australia
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Nedlands, , Australia
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Nedlands, , Australia
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Wahroonga, , Australia
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Waratah, , Australia
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Brasschaat, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Haine-Saint-Paul, , Belgium
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Leuven, , Belgium
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Alfenas, , Brazil
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Blumenau, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Porto Velho, , Brazil
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São Paulo, , Brazil
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Taubaté, , Brazil
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Teresina, , Brazil
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Vitória, , Brazil
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Abbotsford, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Ottawa, Ontario, Canada
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Sault Ste. Marie, Ontario, Canada
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Toronto, Ontario, Canada
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Sherbrooke, Quebec, Canada
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Chicoutimi, , Canada
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Montreal, , Canada
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Beijing, , China
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Beijing, , China
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Bengbu, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hefei, , China
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Jinan, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Nanning, , China
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Shandong, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
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Ürümqi, , China
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Ürümqi, , China
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Wuhan, , China
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Xi'an, , China
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Xi'an, , China
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Xiangyang, , China
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Xuzhou, , China
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Zhengzhou, , China
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Aalborg, , Denmark
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Aarhus N, , Denmark
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Hillerød, , Denmark
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Odense, , Denmark
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Bobigny, , France
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Clermont-Ferrand, , France
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Limoges, , France
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Lyon, , France
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Plérin, , France
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Rouen, , France
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Saint-Herblain, , France
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Villejuif, , France
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Augsburg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bottrop, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Georgsmarienhütte, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heilbronn, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Mannheim, , Germany
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Mönchengladbach, , Germany
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Münster, , Germany
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Regensburg, , Germany
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Stade, , Germany
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Trier, , Germany
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Ulm, , Germany
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Bangalore, , India
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Jaipur, , India
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Jaipur, , India
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Mohali, , India
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Mysuru, , India
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Nagpur, , India
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New Delhi, , India
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New Delhi, , India
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Puducherry, , India
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Vadodara, , India
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Varanasi, , India
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Aviano, , Italy
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Bologna, , Italy
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Catanzaro, , Italy
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Misterbianco, , Italy
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Napoli, , Italy
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Padua, , Italy
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Prato, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Chiba, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Hidaka-shi, , Japan
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Hiroshima, , Japan
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Isehara-shi, , Japan
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Kagoshima, , Japan
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Kōtoku, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Naha, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Ota-shi, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shimotsuke-shi, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Suita-shi, , Japan
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Takasaki-shi, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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George Town, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Selangor, , Malaysia
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Kuala Selangor, , Malaysia
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Kuching, , Malaysia
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Pulau Pinang, , Malaysia
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Koszalin, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Rzeszów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Goyang-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Granada, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Pamplona, , Spain
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Santiago de Compostela, , Spain
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Lund, , Sweden
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Solna, , Sweden
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Vaxjo, , Sweden
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Dusit, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Lampang, , Thailand
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Ratchathewi, , Thailand
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Goztepe Istanbul, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Guildford, , United Kingdom
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London, , United Kingdom
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Londonderry, , United Kingdom
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Taunton, , United Kingdom
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York, , United Kingdom
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Can Tho, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hồ Chí Minh, , Vietnam
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Vinh, , Vietnam
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
AstraZeneca Breast Cancer Study Locator Service
Role: CONTACT
Phone: 1-877-400-4655
Email: [email protected]
Related Links
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Breast Cancer Study Locator details (for US)
Other Identifiers
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2020-004637-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D361DC00001
Identifier Type: -
Identifier Source: org_study_id