EORTC 2237-BCG-QLG: Improvement of Quality of Life through supportive treatments for Endocrine Therapy – related symptoms in patients with early Breast cancer; A pragmatic randomized Controlled Trial (QOL-ET-BC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-02-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

EORTC QoL group · Rising Tide Foundation

External identifiers

EU CT number

2024-513442-10-00

ClinicalTrials.gov

NCT06407401

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Others

The primary objective is to evaluate if patients treated in either intervention arm (duloxetine or furosemide) will have better control of the endocrine therapy related MSK pain, particularly arthralgias and/or myalgias and/or bone pain at 3 months.

Secondary objectives 6

1. To evaluate the rate of discontinuation of the endocrine therapy in either intervention arm compared to the standard arm
2. To evaluate if patients treated in either intervention arm will have better control of the endocrine therapy related MSK pain, particularly arthralgias and/or myalgias and/or bone pain at 6 months
3. To evaluate if patients treated in either intervention arm will have improved global QOL.
4. To evaluate if patients treated in either intervention arm will have improved emotional functioning
5. To evaluate if patients treated in either intervention arm will have improved endocrine therapy related-symptoms
6. To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the three arms

Conditions and MedDRA coding

ER positive HER2 negative breast cancer stages I-II

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Female (both pre- and postmenopausal) or male patients
2. Age ≥18 years
3. Ongoing adjuvant ET for ER positive HER2 negative breast cancer stages I-III
4. Patients must have received at least 3 months and up to 3 years of ET and planned to continue the same ET during the study
5. Adjuvant cyclin dependent kinase 4 and 6 (CDK4/6) inhibitor or poly ADP ribose polymerase (PARP) inhibitor treatment is allowed as long as they are planned to be kept during the study duration
6. Present endocrine therapy related MSK pain (arthralgia and/or bone pain and/or myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit
7. Previous chemotherapy is allowed if completed at least 3 months before enrolment
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
9. Adequate organ function as defined below: • Glomerular filtration rate estimated via the MDRD equation of ≥ 30 mL/min/1.73m2 • Potassium levels ≥ 3.0 mmol/L • Sodium levels ≥ 130 mmol/L • Total bilirubin <1.5 times the upper limit of normal (ULN) (< 3 times the upper limit of normal for Gilbert’s disease)
10. Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ-BR42)
11. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
12. Patients of childbearing / reproductive potential must agree to use at least one highly effective contraceptive measure until treatment discontinuation
13. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment.
14. A breastfeeding patient should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment

Exclusion criteria 12

1. Current history of grade ≥ 2 CTCAE V5.0 depression and/or anxiety
2. History of suicide-related events
3. Current use of diuretics, antidepressants and irreversible monoamine oxidase inhibitors (MAOIs)
4. Current use of prescribed or natural medicines with known interactions with furosemide and/or duloxetine
5. Uncontrolled high blood pressure defined as systolic ≥150 mmHg and ≥ diastolic 100 mmHg
6. Symptomatic hypotension, hypovolemia, or dehydration
7. Addison’s disease
8. Porphyria
9. Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction
10. Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications
11. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule
12. Participation in another interventional study with systemic drugs

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 at month 3. • The skeletal scale score is computed based on the following four individual items from the EORTC QLQ-BR42 questionnaire Have you had problems with your joints? • Have you had stiffness in your joints? • Have you had pain in your joints? • Have you had aches or pains in your bones?

Secondary endpoints 6

1. Discontinuation of endocrine therapy
2. Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 questionnaire at month 6
3. Change from baseline in Global health status/QoL scale according to EORTC-QLQ-C30 questionnaire at 3 and 6 months
4. Change from baseline in Emotional functioning scale according to EORTC-QLQ-C30 questionnaire at 3 and 6 months
5. Change from baseline Endocrine therapy symptoms scale according to EORTC-BR42 questionnaire at 3 and 6 months
6. Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi

Sponsor organisation

Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi

Address

Emmanuel Mounierlaan 83 Bus 11

City

Sint-Lambrechts-Woluwe

Postcode

1200

Country

Belgium

Scientific contact point

Organisation

Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi

Contact name

Stéphanie Kromar

Public contact point

Organisation

Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi

Contact name

Vassilis Golfinopoulos

Locations

5 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Results and documents

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

Documents 47 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