Master

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Midtjylland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Jan 2021 → ongoing

Decision date (initial)

2024-09-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515404-39-00

EudraCT number

2019-002508-42

ClinicalTrials.gov

NCT04601116

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare invasive disease-free survival (IDFS) in patients randomized to standard (neo)adjuvant therapy plus placebo or standard (neo)adjuvant therapy plus atorvastatin (80 mg/day for two years).

Secondary objectives 4

1. To compare overall survival (OS), recurrence-free interval (RFI), distant recurrence-free interval (DRFI) including associations with first site of recurrence, cardiac death-free interval, and overall safety in the two treatment arms.
2. To evaluate pathological response (only neoadjuvant treated patients) according to treatment arm
3. To investigate patient reported outcome measurements.
4. To address translational endpoints as specified in the translational protocol parts.

Conditions and MedDRA coding

Breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy.
2. Age > 18 years.
3. Performance status of ECOG ≤ 2.
4. Prior to patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion criteria 8

1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma.
2. Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm given fulfillment of other in- and exclusion criteria.
3. Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatinine level more than three times the upper limit of the normal range).
4. Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle – or liver disease, or excessive alcohol consumption (above 14 drinks/week) AND creatine kinase (CK) measured to less more than five times the upper limit (CK only measured in case of predisposing factors).
5. Current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol.
6. Pregnancy or breast-feeding (contraception according to clinical routines for premenopausal, fertile breast cancer patients, that includes non-hormonal contraception such as condom, vaginal diaphragm, or intrauterine device).
7. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
8. History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Invasive disease-free survival (IDFS), defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence, Regional invasive breast cancer recurrence, Distant recurrence, Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause, Contralateral invasive breast cancer or Second primary non-breast invasive cancer.

Secondary endpoints 6

1. Pathological response (only neo-adjuvant treated patients)
2. Distant-recurrence free interval defined as time from inclusion to first distant recurrence including associations with first site of recurrence.
3. Recurrence-free interval including associations with first site of recurrence
4. Overall survival.
5. Overall safety.
6. Cardiac death-free interval. Cardiac death is defined as: Definitive cardiac death due to heart failure, myocardial infarction or documented primary arrhythmia.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

Sponsor organisation

Region Midtjylland

Address

Palle Juul-Jensens Boulevard 99

City

Aarhus N

Postcode

8200

Country

Denmark

Scientific contact point

Organisation

Region Midtjylland

Contact name

Signe Borgquist

Public contact point

Organisation

Region Midtjylland

Contact name

Signe Borgquist

Third parties 1

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications