Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer

NCT06407401 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: EORTC-2237-BCG-QLG
• Study Type: interventional
• Target: 399
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+/HER2- early breast cancer with joint, muscle and/or bone pain caused by the endocrine therapy. The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and/or bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).

Conditions

ER+ Breast Cancer; HER2-negative Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Drug-Related Side Effects and Adverse Reactions; Musculoskeletal Pain

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Endocrine therapy related musculoskeletal pain

  Assessed by the Skeletal scale from the EORTC-QLQ-BR42 questionnaire, with the minimum and maximum values being 0 - 100 and higher score means worse outcome.

  3 months

Secondary Outcomes (5)

• Endocrine therapy related musculoskeletal pain

  6 months

• Overall quality of life

  3 months and 6 months

• Emotional functioning

  3 months and 6 months

• Endocrine therapy related symptoms

  3 months and 6 months

• Discontinuation of endocrine therapy

  6 months

Study Arms (3)

Control arm (SoC)

ACTIVE COMPARATOR

Standard of care (SoC) including a booklet focused on healthy behaviors

Behavioral: Booklet for healthy behaviors

Experimental arm SoC with duloxetine

EXPERIMENTAL

Duloxetine 60 mg (1 pill a day) + SoC

Drug: Duloxetine 60 MG; Behavioral: Booklet for healthy behaviors

Experimental arm SoC with Furosemide

EXPERIMENTAL

Furosemide 40 mg (1 pill a day) + SoC

Drug: Furosemide 40 mg; Behavioral: Booklet for healthy behaviors

Interventions

Duloxetine 60 MG DRUG

Patients randomized to the duloxetine arm will take duloxetine orally daily, with or without food, on a continuous dosing schedule. Initial dose is 30 mg daily for 1 week, followed by 60 mg daily for a total of 6 months of treatment, followed by a taper off the medication of 30 mg daily for 1 additional week.

Experimental arm SoC with duloxetine

Furosemide 40 mg DRUG

Patients randomized to the furosemide arm will take furosemide 40 mg orally daily, on an empty stomach with plenty of liquid, on a continuous dosing schedule.

Experimental arm SoC with Furosemide

Booklet for healthy behaviors BEHAVIORAL

All patients will receive usual care, including a booklet focused on healthy behaviors, particularly physical exercise, to manage endocrine therapy side-effects.

Control arm (SoC); Experimental arm SoC with Furosemide; Experimental arm SoC with duloxetine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female (both pre- and postmenopausal) or male patients
• Age ≥18 years
• Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III
• Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction
• 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:
• Grade 2: moderate pain; limiting instrumental activities daily living (ADL)
• Grade 3: severe pain; limiting activities self-care ADL
• Previous chemotherapy is allowed if completed at least 3 months before enrolment
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• Adequate organ function
• Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)
• Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations
• 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.
• Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.
• Patients of childbearing / reproductive potential must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation.

You may not qualify if:

• Current history of moderate/severe depression and/or anxiety, both defined as grade≥2 CTCAE V5.0
• History of suicide-related events
• Current use of diuretics, antidepressants and/or phytoestrogens
• Current use of prescribed or natural medicines with known interactions with furosemide and/or duloxetine
• Contraindications to duloxetine:
• Severe renal impairment (creatinine clearance \< 30 mL/min)
• Uncontrolled hypertension
• Hepatic impairment Child Pugh Class B or C
• Contraindications to furosemide:
• Symptomatic hypotension, hypovolemia, or dehydration
• Severe renal impairment (creatinine clearance \< 30 mL/min)
• Severe hypokalaemia and/or severe hyponatremia
• Addison's disease
• Porphyria
• Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

MeSH Terms

Conditions

Breast Neoplasms; Drug-Related Side Effects and Adverse Reactions; Musculoskeletal Pain

Interventions

Duloxetine Hydrochloride; Furosemide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Chemically-Induced Disorders; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfanilamides; Sulfonamides; Amides; Aniline Compounds; Amines; Sulfones

Central Study Contacts

EORTC HQ

CONTACT

+3227741611; eortc@eortc.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): April 18, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: November 5, 2024

Record last verified: 2024-11