Improving the empowerment in patients with severe breast fibrosis radio-induced treated by Pravastatin : benefit of e-PROs (electronic « Patient Reported Outcome ») on breast-related quality of life

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Regional Du Cancer De Montpellier

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Sep 2024 → ongoing

Decision date (initial)

2024-09-05

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515342-16-00

EudraCT number

2019-004777-11

ClinicalTrials.gov

NCT04356209

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Therapy

The main objective of this study is to evaluate at 12 months the benefit on breast-related quality of life (BRQoL) of systematic e-PROs (alerting the clinicians in case of severe or worsening symptoms) in BC patients treated by Pravastatin during 1 year for severe breast RIF.
A standard surveillance group receiving conventional care (without e-PROs) will constitute an internal control group (control group).

Secondary objectives 9

1. To evaluate the patients’HRQoL.
2. To estimate the use of antidepressants, anxiolytics and analgesics during the target year (dose/ quantity).
3. To assess the levels of psychological distress.
4. To monitor the e-PROs alerts in the experimental group.
5. To characterise the evaluation of the side effects linked to RIF in the experimental group.
6. To characterise the modifications of the patients’ management in the experimental group.
7. To evaluate the anti-fibrotic efficacy of Pravastatin
8. To evaluate the Pravastatin safety.
9. To estimate the relapse-free survival.

Conditions and MedDRA coding

Patients with severe and radio-induced breast fibrosis after breast cancer

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Breast cancer patients treated by conserving surgery followed by adjuvant RT.
2. Over 18 years old.
3. At least, grade 2 breast RIF.
4. Treatment planning data of breast cancer radiotherapy must be available.
5. The following laboratory values obtained ≤ 15 days prior to randomization: Serum creatinine ≤ 130 µmol/l; ASAT and ALAT≤ 2N; total bilirubin ≤ 1.5N; CPK-MM levels < 3 x ULN, only for the women ≥ 70 years.
6. Negative pregnancy test (β-HCG dosage ≤ 15 days prior to randomization) in women of childbearing potential (women not of reproductive potential are female patients who are postmenopausal or permanently sterilized: e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
7. Patient without contraindication to treatment with Pravastatin.
8. Signed and dated written consent.
9. Patient must be affiliated to a French Social Security System

Exclusion criteria 13

1. 1. Any breast cancer recurrences.
2. Current treatment by : statin, fibrate, ciclosporin, systemic fusidic acid, long-term treatment by corticoids.
3. History of muscular dystrophy diseases or chronic and/or hereditary muscular diseases
4. Untreated hypothyroidism.
5. Serum creatinine > 130 µmol/l; ASAT and ALAT > 2N; total bilirubin > 1.5N.
6. CPK-MM levels > 3 x ULN in women over 70 years.
7. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody.
8. Pregnant or breastfeeding women.
9. Women of childbearing potential who are unwilling to employ adequate contraception, from the beginning of the study to 4 weeks after last treatment dose.
10. Known hypersensitivity to Pravastatin, or any constituent of the product.
11. Patient with alcohol misuse.
12. Patients treated with systemic investigational drugs within the past 30 days.
13. Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the BRQoL improvement rate at 12 months, compared with baseline, defined as: - An improvement of 5 points (or more) of the score assessed by the functional scale “body image” of the QLQ-BR23 (summary score including the items # 39-42), or - a reduction of 5 points (or more) of the score on the symptom scale “breast symptoms” assessed by the QLQ-BR23 (summary score including the items # 51- 53).

Secondary endpoints 9

1. Health-related quality of life assessed by the EORTC QLQ-C30 and its module BR23 (at baseline; 12 months, visit of end of treatment with Pravastatin; during the follow-up: month 24, 36, 48 and 60) (see appendix 1 and 2).
2. Rate and dose of used antidepressants, anxiolytics and analgesics.
3. Psychological distress assessed by the Hospital Anxiety and Depression Scale (at baseline; 12 months, visit of end of treatment with Pravastatin; during the follow-up: month 24, 36, 48 and 60)
4. Timing of the e-PROs alerts and the care management (phone call or planning of a consultation, treatment initiation).
5. Evolution of the 7 different e-PROs scores across time (scores of general pain, anxiety, sadness, texture of the treated breast, two other symptoms assessed by the PRO-CTCAE scales, and scores of aesthetic impact assesses by a Visual Analog Scale)
6. Number of hospital emergency visits or hospitalizations.
7. Number of supplementary consultations.
8. Regression rate of at least 1 grade of fibrosis (follow-up of fibrosis grade evolution since inclusion).
9. Relapse-free survival defined as the time from the date of randomization to the date of the first observed oncological event such as local, ipsilateral, regional or metastatic recurrence or death for any cause.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Regional Du Cancer De Montpellier

Sponsor organisation

Institut Regional Du Cancer De Montpellier

Address

208 Avenue Des Apothicaires

City

Montpellier Cedex 5

Postcode

34298

Country

France

Scientific contact point

Organisation

Institut Regional Du Cancer De Montpellier

Contact name

project manager

Public contact point

Organisation

Institut Regional Du Cancer De Montpellier

Contact name

project manager

Sponsor responsibilities

Article 77 compliance

Institut Regional Du Cancer De Montpellier

Contact point sponsor

Institut Regional Du Cancer De Montpellier

Article 77 implementation

Institut Regional Du Cancer De Montpellier

Locations

1 EU/EEA country · 4 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

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