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Clinical Trial Results:
A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer

Summary
EudraCT number	2014-005126-35
Trial protocol	DE
Global end of trial date	19 Jan 2021

Results information
Results version number	v1(current)
This version publication date	09 Sep 2022
First version publication date	09 Sep 2022
Other versions
Summary report(s)	DESIREE_CSR_Synopsis

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

GBG86-DESIREE

ISRCTN number

US NCT number

NCT02387099

WHO universal trial number (UTN)

Other trial identifiers

Novartis: CRAD001JDE60T

Sponsor organisation name

GBG Forschungs GmbH

Sponsor organisation address

Martin Behaim Str. 12, Neu-Isenburg, Germany, 63263

Public contact

Medicine and Research, GBG Forschungs GmbH, publications@gbg.de

Scientific contact

Medicine and Research, GBG Forschungs GmbH, publications@gbg.de

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

09 Sep 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

19 Jan 2021

Global end of trial reached?

Yes

Global end of trial date

19 Jan 2021

Was the trial ended prematurely?

Main objective of the trial

To compare the cumulative rate of stomatitis grade 2-4 (WHO’s oral toxicity scale (OTS)) at 12 weeks after start of treatment using a conventional and a dose-escalating schema of everolimus in combination with exemestane in patients with metastatic breast cancer and progression or relapse after non-steroidal aromatase-inhibitor treatment.

Protection of trial subjects

The trial protocol including amendments, the patient information and the informed consent were reviewed and approved from a properly constituted IRB/IEC for each site prior to the study start. The trial was in compliance with the International Conference on Harmonization (ICH) - Harmonized Tripartite Guideline for Good Clinical Practice (GCP) (E6), and the Commission Directives in the European Community as well as with the applicable German national laws and regulations, and with Declaration of Helsinki and its revisions in all aspects of preparation, monitoring, reporting, auditing, and archiving.

Background therapy

exemestane treatment

Evidence for comparator

Standard of Care (SoC)

Actual start date of recruitment

01 Apr 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 156

Worldwide total number of subjects

156

EEA total number of subjects

156

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Between June 2015 and October 2020, 208 patients were screened, 160 patients were randomised to receive either EVE esc (80 patients) or EVE 10mg (80 patients), and 156 started treatment.

Screening details

Postmenopausal women with locally advanced or metastatic HR+/HER2- BC not amenable to curative treatment by surgery or radiotherapy alone and without indication for chemotherapy (e.g. symptomatic visceral metastasis).

Period 1 title

overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst

Blinding implementation details

After a dose escalation period of 3 weeks which was double-blinded (blinded phase), the interventional part of the study was completed and the patient continued on prescribed everolimus as part of SoC (open-label phase).

Are arms mutually exclusive

Yes

EVE esc

Arm description

A total of 80 patients were randomised to receive dose escalating schema of everolimus (EVE esc) in combination with exemestane and started treatment. 22 patients completed 24 weeks treatment with everolimus and 23 completed 24 weeks treatment with exemestane. Note, the number of patients started treatment is given for "started".

Arm type

Experimental

Investigational medicinal product name

Everolimus

Investigational medicinal product code

Other name

Afinitor

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

week 1: 3x2.5 mg placebo and 1x2.5 mg everolimus; week 2: 2x2.5 mg placebo and 2x2.5 mg everolimus; week 3: 1x2.5 mg placebo and 3x2.5 mg everolimus; weeks 4-24: 4x2.5 mg everolimus (open-label).

EVE 10mg

Arm description

A total of 80 patients were randomised to receive a conventional schema of 10 mg of everolimus (EVE 10mg) in combination with exemestane, 76 started treatment (4 patients did not start study treatment: one due to multiple brain metastases, 2 due to too long drug delivery time before start of study treatment, and one due to withdrew informed consent). 26 patients completed 24 weeks treatment with everolimus and 22 completed 24 weeks treatment with exemestane. Note, the number of patients started treatment is given for "started".

Arm type

Active comparator

Investigational medicinal product name

Everolimus

Investigational medicinal product code

Other name

Afinitor

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Standard administration schedule of everolimus /everolimus-placebo: 10 mg/day (4 tablets of 2.5 mg), orally administrated

Number of subjects in period 1	EVE esc	EVE 10mg
Started	80	76
Completed	22	26
Not completed	58	50
Adverse event, serious fatal	1	3
Adverse event, non-fatal	8	10
patient/investigation decision	10	12
disease progression	39	25

Baseline characteristics

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Reporting group title

EVE esc

Reporting group description

Reporting group title

EVE 10mg

Reporting group description

Reporting group values	EVE esc	EVE 10mg	Total
Number of subjects	80	76	156
Age categorical
Units: Subjects
Adults (18-64 years)	40	41	81
From 65-84 years	38	35	73
85 years and over	2	0	2
Gender categorical
Units: Subjects
Female	80	76	156
Male	0	0	0

End points

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Reporting group title

EVE esc

Reporting group description

Reporting group title

EVE 10mg

Reporting group description

Primary: Rate of stomatitis episodes grade ≥2 at 12 weeks

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End point title

Rate of stomatitis episodes grade ≥2 at 12 weeks

End point description

The primary endpoint was the rate of stomatitis episodes grade ≥2 within the first 12 weeks of treatment start. Patients with first episode of grade ≥2 stomatitis which occurred during 12-week period after start of everolimus were included in the numerator of the cumulative rate. Patients in whom the occurrence of stomatitis could not be assessed during 12-week period due to premature treatment discontinuation as a results of adverse events (AEs), patient’s or investigator’s decision were considered as having an episode of stomatitis.

End point type

Primary

End point timeframe

12 weeks

End point values	EVE esc	EVE 10mg
Number of subjects analysed	80	76
Units: percent
number (confidence interval 95%)
Stomatitis episodes	28.8 (19.2 to 40.0)	46.1 (34.5 to 57.9)

Rate of stomatitis episodes - differences

Statistical analysis description

Primary endpoint analysis was performed in the modified intent-to-treat (mITT) analysis set including all randomised patients who started therapy.

Comparison groups

EVE esc v EVE 10mg

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.039

Method

Chi-squared corrected

Parameter type

absolute differences

Point estimate

-17.3

Confidence interval

level

95%

sides

2-sided

lower limit

-32.3

upper limit

-2.3

Notes
[1] - Differences in the rates of stomatitis episodes were tested using a continuity-corrected χ2-test (α=0.20)

Rate of stomatitis episodes - odds ratio

Statistical analysis description

The primary endpoint analysis was performed on the modified intent-to-treat (mITT) analysis set including all randomized patients who started therapy. Odds ratios (OR) with the 95% CI are displayed.

Comparison groups

EVE esc v EVE 10mg

Number of subjects included in analysis

156

Analysis specification

Post-hoc

Analysis type

superiority ^[2]

P-value

= 0.011 ^[3]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

0.81

Notes
[2] - Multivariate logistic regression analysis adjusted for age, ECOG PS, BMI, and number of previous therapy lines for mBC
[3] - multivariate logistic regression analysis

Adverse events

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Timeframe for reporting adverse events

All adverse events occurring during the 24-week treatment period were reported.

Adverse event reporting additional description

AEs are reported per patient during the complete treatment duration for the overall safety population. Non-serious AEs any grade per patient occurring more frequently (> 20%) are presented. Note, overall number of single AE occurrences per term was not assessed, only per patient; SAEs are reported regardless of causality

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

EVE esc

Reporting group description

dose escalating schema of everolimus in combination with exemestane. Note, one patient who was randomized to EVE esc arm received EVE 10mg during the first 3 weeks of treatment and therefore this patient was analysed in the EVE 10mg arm (EVE esc N=79)

Reporting group title

EVE 10mg

Reporting group description

Conventional dosing schedule of everolimus starting with 10 mg at first dose in combination with exemestane. Note, one patient who was randomized to EVE esc arm received EVE 10mg during the first 3 weeks of treatment and therefore this patient was analysed in the EVE 10mg arm. Another patient in the EVE 10mg was excluded from the safety analysis due to uncompleted safety documentation (missing data) (EVE 10mg N=76)

Serious adverse events	EVE esc	EVE 10mg
Total subjects affected by serious adverse events
subjects affected / exposed	23 / 79 (29.11%)	22 / 76 (28.95%)
number of deaths (all causes)	1	3
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Lymphoedema
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Bone operation
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenterostomy
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleurodesis
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
General physical health deterioration
subjects affected / exposed	2 / 79 (2.53%)	4 / 76 (5.26%)
occurrences causally related to treatment / all	0 / 2	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Mucosal inflammation
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Hypersensitivity
subjects affected / exposed	1 / 79 (1.27%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 79 (0.00%)	3 / 76 (3.95%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	3 / 79 (3.80%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Cardiac failure
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Seizure
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 79 (1.27%)	3 / 76 (3.95%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ascites
subjects affected / exposed	0 / 79 (0.00%)	2 / 76 (2.63%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	1 / 79 (1.27%)	2 / 76 (2.63%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	2 / 79 (2.53%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pyloric stenosis
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Jaundice
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Cystitis haemorrhagic
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hydronephrosis
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	2 / 79 (2.53%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bone pain
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abscess jaw
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device related infection
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis norovirus
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Parotitis
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngeal abscess
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	2 / 79 (2.53%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound infection
subjects affected / exposed	0 / 79 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	1 / 79 (1.27%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	EVE esc	EVE 10mg
Total subjects affected by non serious adverse events
subjects affected / exposed	79 / 79 (100.00%)	76 / 76 (100.00%)
Investigations
Blood alkaline phosphatase increased
subjects affected / exposed	41 / 79 (51.90%)	36 / 76 (47.37%)
occurrences all number	41	36
Aspartate aminotransferase increased
subjects affected / exposed	63 / 79 (79.75%)	55 / 76 (72.37%)
occurrences all number	63	55
Alanine aminotransferase increased
subjects affected / exposed	53 / 79 (67.09%)	41 / 76 (53.95%)
occurrences all number	53	41
Blood creatinine increased
subjects affected / exposed	24 / 79 (30.38%)	31 / 76 (40.79%)
occurrences all number	24	31
Weight decreased
subjects affected / exposed	16 / 79 (20.25%)	22 / 76 (28.95%)
occurrences all number	16	22
serum cholestrol increased
subjects affected / exposed	61 / 79 (77.22%)	65 / 76 (85.53%)
occurrences all number	61	65
LDL/HDL ratio increased
subjects affected / exposed	41 / 79 (51.90%)	55 / 76 (72.37%)
occurrences all number	41	55
LDL/HDL ratio decreased
subjects affected / exposed	76 / 79 (96.20%)	71 / 76 (93.42%)
occurrences all number	76	71
Nervous system disorders
Headache
subjects affected / exposed	24 / 79 (30.38%)	17 / 76 (22.37%)
occurrences all number	24	17
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	59 / 79 (74.68%)	62 / 76 (81.58%)
occurrences all number	59	62
Leukopenia
subjects affected / exposed	53 / 79 (67.09%)	51 / 76 (67.11%)
occurrences all number	53	51
Thrombocytopenia
subjects affected / exposed	29 / 79 (36.71%)	36 / 76 (47.37%)
occurrences all number	29	36
Neutropenia
subjects affected / exposed	33 / 79 (41.77%)	29 / 76 (38.16%)
occurrences all number	33	29
General disorders and administration site conditions
Fatigue
subjects affected / exposed	42 / 79 (53.16%)	40 / 76 (52.63%)
occurrences all number	42	40
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	28 / 79 (35.44%)	19 / 76 (25.00%)
occurrences all number	28	19
Nausea
subjects affected / exposed	23 / 79 (29.11%)	26 / 76 (34.21%)
occurrences all number	23	26
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	24 / 79 (30.38%)	21 / 76 (27.63%)
occurrences all number	24	21
Dyspnoea
subjects affected / exposed	16 / 79 (20.25%)	23 / 76 (30.26%)
occurrences all number	16	23
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	18 / 79 (22.78%)	22 / 76 (28.95%)
occurrences all number	18	22
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	22 / 79 (27.85%)	16 / 76 (21.05%)
occurrences all number	22	16
Hypertriglyceridaemia
subjects affected / exposed	58 / 79 (73.42%)	55 / 76 (72.37%)
occurrences all number	58	55
Hypoglycaemia
subjects affected / exposed	16 / 79 (20.25%)	9 / 76 (11.84%)
occurrences all number	16	9
Hyperglycaemia
subjects affected / exposed	45 / 79 (56.96%)	46 / 76 (60.53%)
occurrences all number	45	46

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Rate of stomatitis episodes grade ≥2 at 12 weeks

Primary: Rate of stomatitis episodes grade ≥2 at 12 weeks

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Rate of stomatitis episodes grade ≥2 at 12 weeks

Primary: Rate of stomatitis episodes grade ≥2 at 12 weeks

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer