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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04305496




Registration number
NCT04305496
Ethics application status
Date submitted
20/02/2020
Date registered
12/03/2020
Date last updated
18/11/2020

Titles & IDs
Public title
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
Scientific title
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor
Secondary ID [1] 0 0
D3615C00001
Universal Trial Number (UTN)
Trial acronym
CAPItello-291
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 - Fulvestrant
Treatment: Drugs - Capivasertib
Treatment: Drugs - Placebo

Experimental: Capivasertib + fulvestrant - Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Capivasertib: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.

Placebo Comparator: Placebo + fulvestrant - Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter.
Placebo: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.


Treatment: Drugs: Fulvestrant
Patients will be administered 500 mg (2 injections) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter

Treatment: Drugs: Capivasertib
400 mg (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle

Treatment: Drugs: Placebo
400 mg of placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) in the overall population - Progression-Free Survival by investigator assessment (in accordance with RECIST 1.1)
Timepoint [1] 0 0
The time from date of randomisation to the date of progression or death due to any cause, whichever occurs earlier, up to approximately 51 months
Secondary outcome [1] 0 0
PFS in PIK3CA/AKT1/PTEN-altered subgroup - Progression-Free Survival by investigator assessment (in accordance with RECIST 1.1)
Timepoint [1] 0 0
The time from date of randomisation to the date of progression or death due to any cause, whichever occurs earlier, up to approximately 51 months
Secondary outcome [2] 0 0
Overall Survival (OS) - Overall Survival (OS)
Timepoint [2] 0 0
The time from date of randomisation to the date of death due to any cause up to 51 months
Secondary outcome [3] 0 0
Investigator assessment of PFS2 - PFS2 - time from randomisation to second progression by investigator assessment
Timepoint [3] 0 0
The time from the date of randomisation to the date of progression subsequent to the first subsequent therapy, or death due to any cause, whichever occurs earlier, up to approximately 51 months
Secondary outcome [4] 0 0
Response Rate (ORR) - percentage of patients with at least one investigator-assessed visit response of complete or partial response (as assessed by the investigator, using RECIST 1.1)
Timepoint [4] 0 0
Up to Approximately 51 months
Secondary outcome [5] 0 0
Duration of Response (DoR) - time from the date of first documented response until date of documented progression (as assessed by the investigator, using RECIST 1.1) or death in the absence of disease progression
Timepoint [5] 0 0
Up to Approximately 51 months
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR) - number of patients with complete or partial response or with stable disease maintained =24 weeks after randomisation (as assessed by the investigator, using RECIST 1.1)
Timepoint [6] 0 0
Up to Approximately 51 months
Secondary outcome [7] 0 0
ocurrence/frequency of AEs and its relationship to study drugs (safety and tolerability) - AEs graded according to the National Cancer Institute (NCI CTCAE)
Timepoint [7] 0 0
Up to Approximately 51 months
Secondary outcome [8] 0 0
plasma concentration of capivasertib - plasma concentration of capivasertib pre-dose and post-dose (C1h and C4h) in the overall population
Timepoint [8] 0 0
Minimum plasma concentration (Cmin), plasma concentration 1 hour post-dose (C1h) and 4 hours post-dose (C4h) during cycles 1 and 2 (each cycle is 28 days)
Secondary outcome [9] 0 0
EORTC QLQ BR23(European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire breast cancer specific module) - The self-administered instrument includes 23-items and yields 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Items are scored on a 4-point verbal rating scale: "Not at All," "A Little," "Quite a Bit," and "Very Much". Scores are transformed to a 0 to 100 scale, where higher scores indicate better unctioning, better HRQoL, or greater level of symptom
Timepoint [9] 0 0
Up to Approximately 51 months
Secondary outcome [10] 0 0
The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items) - 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), and global health status/QoL scale, along with 5 individual item symptom scores (appetite loss, dyspnoea, insomnia, constipation, and diarrhoea. The EORTC QLQ-C30 will be scored according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). Higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales/scores represent greater symptom severity
Timepoint [10] 0 0
Up to Approximately 51 months
Secondary outcome [11] 0 0
Time to definitive deterioration of the ECOG (Eastern Cooperative Oncology Group) performance status - Time from randomisation to the earlier of the date of the first definitive deterioration or death due to any cause. Deterioration is defined as a 1-point decrease in ECOG score from baseline, and the deterioration is considered definitive if no improvements in the ECOG performance status are observed at a subsequent time of measurement during the treatment period, or at no further assessments following the time point where the deterioration is observed
Timepoint [11] 0 0
Up to approximately 51 months

Eligibility
Key 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 at least 4
weeks prior to 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; 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 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
Minimum age
18 Years
Maximum age
130 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 sensitive substrates of CYP3A4,
CYP2C9 and/or CYP2D6 with a narrow therapeutic window 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 corrected QT interval (QTc) >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 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 (if
applicable)

11. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Ballarat
Recruitment hospital [3] 0 0
Research Site - Birtinya
Recruitment hospital [4] 0 0
Research Site - Box Hill
Recruitment hospital [5] 0 0
Research Site - Concord
Recruitment hospital [6] 0 0
Research Site - East Albury
Recruitment hospital [7] 0 0
Research Site - Kurralta Park
Recruitment hospital [8] 0 0
Research Site - North Sydney
Recruitment hospital [9] 0 0
Research Site - Orange
Recruitment hospital [10] 0 0
Research Site - Ringwood East
Recruitment hospital [11] 0 0
Research Site - South Brisbane
Recruitment hospital [12] 0 0
Research Site - Waratah
Recruitment hospital [13] 0 0
Research Site - Wendouree
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
2139 - Concord
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2640 - East Albury
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5037 - Kurralta Park
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2060 - North Sydney
Recruitment postcode(s) [9] 0 0
2800 - Orange
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3135 - Ringwood East
Recruitment postcode(s) [11] 0 0
4101 - South Brisbane
Recruitment postcode(s) [12] 0 0
2298 - Waratah
Recruitment postcode(s) [13] 0 0
3355 - Wendouree
Recruitment outside Australia
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State/province [145] 0 0
Taoyuan
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Aberdeen
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Blackpool
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Bournemouth
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Bristol
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Cardiff
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Cheltenham
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Derby
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Huddersfield
Country [154] 0 0
United Kingdom
State/province [154] 0 0
Lancaster
Country [155] 0 0
United Kingdom
State/province [155] 0 0
Leeds
Country [156] 0 0
United Kingdom
State/province [156] 0 0
London
Country [157] 0 0
United Kingdom
State/province [157] 0 0
Manchester
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Sutton
Country [159] 0 0
United Kingdom
State/province [159] 0 0
York

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

Ethics approval
Ethics application status

Summary
Brief summary
Phase III, double-blind, randomised study assessing the efficacy of capivasertib +
fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced
(inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or
after AI therapy.
Trial website
https://clinicaltrials.gov/show/NCT04305496
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04305496