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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04862663




Registration number
NCT04862663
Ethics application status
Date submitted
17/03/2021
Date registered
28/04/2021

Titles & IDs
Public title
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
Scientific title
A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)
Secondary ID [1] 0 0
2020-004637-20
Secondary ID [2] 0 0
D361DC00001
Universal Trial Number (UTN)
Trial acronym
CAPItello-292
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced (Inoperable) or Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Capivasertib
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Palbociclib
Treatment: Drugs - Ribociclib
Treatment: Drugs - Abemaciclib

Experimental: Capivasertib Plus Palbociclib and Fulvestrant - Capivasertib Plus Palbociclib and Fulvestrant (Ph 1b)

Experimental: Capivasertib Plus Ribociclib and Fulvestrant - Capivasertib Plus Ribociclib and Fulvestrant (Ph 1b)

Experimental: Capivasertib Plus Abemaciclib and Fulvestrant - Capivasertib Plus Abemaciclib and Fulvestrant (Ph 1b)

Experimental: 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)

Active comparator: Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib) - Fulvestrant and investigator's choice of CDK4/6i (palbociclib or ribociclib) (Ph III)


Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: Abemaciclib
Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol.
Timepoint [1] 0 0
Within the first 28 day cycle.
Primary outcome [2] 0 0
Phase Ib: 2. The number of participants with treatment-related adverse events.
Timepoint [2] 0 0
From baseline up to approximately 36 months.
Primary outcome [3] 0 0
Phase Ib: 3. The number of participants with treatment-related serious adverse events.
Timepoint [3] 0 0
From baseline up to approximately 36 months.
Primary outcome [4] 0 0
Phase III: 1. Progression Free Survival (PFS).
Timepoint [4] 0 0
Up to approximately 47 months.
Secondary outcome [1] 0 0
Phase Ib: 1. PK parameters for Palbociclib, Ribociclib, Abemaciclib: Cmax.
Timepoint [1] 0 0
Cycle 0 (Cycle 0 is 3 days), Cycle 1 Day 11 and Cycle 1 Day 14 (Cycle 1 is 28 days).
Secondary outcome [2] 0 0
Phase Ib: 2. PK parameters for Palbociclib, Ribociclib, Abemaciclib: AUC0-72h.
Timepoint [2] 0 0
Cycle 0 (Cycle 0 is 3 days).
Secondary outcome [3] 0 0
Phase Ib: 3. PK parameters for Palbociclib, Ribociclib, Abemaciclib: AUC0-24h.
Timepoint [3] 0 0
Cycle 0 (Cycle 0 is 3 days), Cycle 1 Day 11 and Cycle 1 Day 14 (Cycle 1 is 28 days).
Secondary outcome [4] 0 0
Phase Ib: 4. PK parameters for Palbociclib, Ribociclib, Abemaciclib: Cmin.
Timepoint [4] 0 0
Cycle 1 Day 11 and Cycle 1 Day 14 (Cycle 0 is 3 days and Cycle 1 is 28 days).
Secondary outcome [5] 0 0
Phase Ib: 5. PK parameters for capivasertib: Cmax.
Timepoint [5] 0 0
Cycle 1 Day 11 (Cycle 0 is 3 days and Cycle 1 is 28 days).
Secondary outcome [6] 0 0
Phase Ib: 6. PK parameters for capivasertib: AUC0-12h.
Timepoint [6] 0 0
Cycle 1 Day 11 (Cycle 0 is 3 days and Cycle 1 is 28 days).
Secondary outcome [7] 0 0
Phase Ib: 7. PK parameters for capivasertib: Cmin.
Timepoint [7] 0 0
Cycle 1 Day 11 (Cycle 0 is 3 days and Cycle 1 is 28 days).
Secondary outcome [8] 0 0
Phase Ib: 8. Objective Response Rate (ORR).
Timepoint [8] 0 0
Up to approximately 36 months.
Secondary outcome [9] 0 0
Phase Ib: 9. Clinical Benefit Rate (CBR) at 24 weeks.
Timepoint [9] 0 0
Up to approximately 36 months.
Secondary outcome [10] 0 0
Phase Ib: 10. Duration of Response (DoR).
Timepoint [10] 0 0
Up to approximately 36 months.
Secondary outcome [11] 0 0
Phase Ib: 11. Progression Free Survival (PFS).
Timepoint [11] 0 0
Up to approximately 36 months.
Secondary outcome [12] 0 0
Phase III: 1. Overall Survival (OS).
Timepoint [12] 0 0
Up to approximately 69 months.
Secondary outcome [13] 0 0
Phase III: 2. Objective Response Rate (ORR).
Timepoint [13] 0 0
Up to approximately 47 months.
Secondary outcome [14] 0 0
Phase III: 3. Progression Free Survival 2 (PFS2)
Timepoint [14] 0 0
Up to approximately 69 months.
Secondary outcome [15] 0 0
Phase III: 4. Duration of Response (DoR).
Timepoint [15] 0 0
Up to approximately 47 months.
Secondary outcome [16] 0 0
Phase III: 5. Clinical Benefit Rate (CBR) at 24 weeks.
Timepoint [16] 0 0
Up to approximately 47 months.
Secondary outcome [17] 0 0
Phase III: 6. Participant-reported physical functioning
Timepoint [17] 0 0
Up to approximately 69 months.
Secondary outcome [18] 0 0
Phase III: 7. Participant-reported GHS/QoL in participants
Timepoint [18] 0 0
Up to approximately 69 months.
Secondary outcome [19] 0 0
Phase III: 8. Participant-reported overall side effect bother in participants in the capivasertib arm relative to control arm
Timepoint [19] 0 0
Up to approximately 69 months.
Secondary outcome [20] 0 0
Phase III: 9. Plasma concentration of capivasertib pre- and post-dose.
Timepoint [20] 0 0
Up to approximately 69 months.
Secondary outcome [21] 0 0
Phase III: 10. The number of participants with adverse events.
Timepoint [21] 0 0
Up to approximately 69 months.
Secondary outcome [22] 0 0
Phase III: 11. The number of participants with serious adverse events.
Timepoint [22] 0 0
Up to approximately 69 months.

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/08/2029
Actual
Sample size
Target
895
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Miranda
Recruitment hospital [3] 0 0
Research Site - Nedlands
Recruitment hospital [4] 0 0
Research Site - Perth
Recruitment hospital [5] 0 0
Research Site - Wahroonga
Recruitment hospital [6] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2228 - Miranda
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment postcode(s) [5] 0 0
2076 - Wahroonga
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment outside Australia
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Vinh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04862663