Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
74
Countries
1
Sites
4
Early Breast Cancer
The primary objective of this study is to evaluate the effect of a 6-month training program in QoL-related to ET.
Key facts
- Sponsor
- Fundacion Grupo Espanol De Investigacion En Cancer De Mama
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-12-29
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novartis (partial funder of the clinical trial).
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The primary objective of this study is to evaluate the effect of a 6-month training program in QoL-related to ET.
Secondary objectives 9
- Global QoL
- AI associated musculoskeletal syndrome (AIMSS) (including bone mass loss, arthralgias/myalgias, joint stiffness/numbness).
- Fatigue.
- Adherence and compliance to treatment.
- Body composition
- Adherence to the exercise program
- Information on sexual relations (libido, body image and vaginal dryness).
- Cognitive impairment.
- Seguridad y tolerabilidad del tratamiento.
Conditions and MedDRA coding
Early Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10085561 | Hormone receptor negative HER2 positive breast cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Written informed consent document (ICD) prior to any specific study procedures, showing patience, willingness and ability to comply with the physical activity program in the experimental group, and scheduled visits and study procedures in both groups.
- Patients ≥18 years of age at signing of ICD.
- Documented histologically confirmed HR+/HER2− invasive EBC, adequately treated according to standard clinical practice and with absence of any evidence of disease (loco-regional or metastatic at distance). HR and HER2 assessments are performed under institutional guidelines. HR testing should utilize an assay consistent with the most recent ASCO/CAP Guidelines. HER2 negativity is determined as immunohistochemistry (IHC) score 0/1+ or negative by in situ hybridization (ISH) according to the recommendations of the most recent ASCO/CAP Guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
- Pre-, peri-, and post-menopausal women (as determined by the investigator and according to the institutional guidelines) that have already received between 10 and 18 weeks of an AI (with or without a LHRHa) before the randomization in the study and administered according to local guidelines. NOTE: Patients that are candidates to receive an adjuvant CDK4/6i will only be eligible if the CDK4/6i was initiated at least 6 weeks before the randomization in the study and administered according to local guidelines.
- Patients must have undergone adequate (definitive) loco-regional therapy (surgery with or without radiation therapy), with or without neo-/adjuvant systemic CT
- Patients must have an adequate organ and bone marrow function according to the standard clinical practice and institutional guidelines
- Patients must be able and willing to fill out repeated questionnaires on QoL, pain and fatigue, as well as to adhere to the physical activity program.
- Fluent Spanish language skills for the complete comprehension of the questionnaires.
- With the consent of the investigator for participation in physical training and considering the medical history of the patient.
Exclusion criteria 9
- Patients have received less than 10 weeks or more than 18 weeks of an AI (with or without a LHRHa) before the randomization in the study.
- Patients that are candidate to receive an adjuvant CDK4/6i initiated the treatment less than 6 weeks before the randomization in the study.
- Patients have musculoskeletal injuries.
- Patients have known significant heart disease (myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, etc.).
- Patients with weight over 150kg.
- Patients have any type of illness or mental condition that prevents or compromises the well-being of the patient or compliance with the procedures.
- Patients have any cardiovascular contraindication to physical training by the investigator.
- Patients have been performing supervised training, either aerobic and/or resistance training (at a gym [group or individual classes] or in a specific sport), at least 2 days per week in the past 6 months.
- No access and/or unable to manage the website and other digital tools (i.e. applications) for training sessions.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint will consist on determining of the changes from baseline in the QoL-related to ET symptoms measured by the EORTC QLQ-BR45 questionnaire (questions 54-56, 63-69).
Secondary endpoints 9
- Change from baseline in global QoL that will be evaluated by questions 29-30 of the EORTC QLQ-C30 questionnaire.
- AIMSS will be assessed using the Brief Pain Inventory (BPI) scale.
- Fatigue will be measured by the Brief Fatigue Inventory (BFI) scale.
- Adherence and compliance to treatment will be recorded using the pill counting method and patient diary
- Body composition will be measured by bioimpedance scale. Weight, body mass index (BMI), lean, muscle and fat mass (including visceral fat), water percentage, bone density and basal metabolic rate will be collected
- Adherence to the exercise program will be recorded through the exercise professionals’ assistance and assessment through the virtual training platform (called “10 Mets”).
- Sexual relations (libido, body image and vaginal dryness) will be evaluated through the specific items included in the EORTC QLQ-BR45 questionnaire (questions 39-42, 44-46 and 70-73).
- Cognitive impairment will be evaluated through the specific items included in the EORTC QLQ-C30 questionnaire (questions 20 and 25).
- Safety will be assessed by standard clinical and laboratory tests (hematology, serum chemistry). Adverse events (AEs) grade will be defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0. Tolerability will be assessed by incidence of treatment dose modifications, discontinuations due to AEs, number of administered cycles, dose intensity, etc.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Kisqali 200 mg film-coated tablets
PRD5341538 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 150 mg film-coated tablets
PRD6701108 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/007
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 100 mg film-coated tablets
PRD6701103 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XE50 — -
- Marketing authorisation
- EU/1/18/1307/004
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Verzenios 50 mg film-coated tablets
PRD6701098 · Product
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 7
PRD7199074 · Product
- Active substance
- Leuprorelin Acetate
- Substance synonyms
- LEUPROLIDE ACETATE
- Pharmaceutical form
- PROLONGED-RELEASE SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 22.50 mg milligram(s)
- Max total dose
- 22.50 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE02 — LEUPRORELIN
- Marketing authorisation
- 83376
- MA holder
- GP-PHARM S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lutrate Depot Mensual 3,75 mg polvo y disolvente para suspensión inyectable de liberación prolongada
PRD7196316 · Product
- Active substance
- Leuprorelin Acetate
- Substance synonyms
- LEUPROLIDE ACETATE
- Pharmaceutical form
- PROLONGED-RELEASE SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 3.75 mg milligram(s)
- Max total dose
- 3.75 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE02 — LEUPRORELIN
- Marketing authorisation
- 83377
- MA holder
- GP-PHARM S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Aromasil 25 mg comprimidos recubiertos
PRD12357733 · Product
- Active substance
- Exemestane
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- 63.029
- MA holder
- PFIZER S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10779510 · Product
- Active substance
- Goserelin
- Pharmaceutical form
- IMPLANT
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 10.8 mg milligram(s)
- Max total dose
- 10.8 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE03 — GOSERELIN
- Marketing authorisation
- 11924
- MA holder
- ASTRAZENECA OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10779493 · Product
- Active substance
- Goserelin
- Pharmaceutical form
- IMPLANT
- Route of administration
- INTRACOCHLEAR INJECTION
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 3.6 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE03 — GOSERELIN
- Marketing authorisation
- 9519
- MA holder
- ASTRAZENECA OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Arimidex® 1 mg film-coated tablets
PRD410197 · Product
- Active substance
- Anastrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG03 — ANASTROZOLE
- Marketing authorisation
- PL 17901/0002
- MA holder
- ASTRAZENECA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12617079 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.5 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- PL 23860/0012
- MA holder
- NOVARTIS IRELAND LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Grupo Espanol De Investigacion En Cancer De Mama
- Sponsor organisation
- Fundacion Grupo Espanol De Investigacion En Cancer De Mama
- Address
- Avenida De Los Pirineos 7 Oficina 1-14, Industrial Zona Sur Industrial Zona Sur
- City
- San Sebastian De Los Reyes
- Postcode
- 28703
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Grupo Espanol De Investigacion En Cancer De Mama
- Contact name
- Clinical Operations Department
Public contact point
- Organisation
- Fundacion Grupo Espanol De Investigacion En Cancer De Mama
- Contact name
- Clinical Operations Department
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 74 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Quironsalud Sagrado Corazon
Oncology, Calle De Rafael Salgado 3, 41013, Sevilla
Hospital Universitario Clinico San Cecilio
Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Universitario De Navarra
Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-522848-40_public | 1.1 |
| Protocol (for publication) | D4_Patient facing document_Patient Card | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Patient Diary | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_public | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Arimidex | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Aromasil | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Femara | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC kisqali | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lutrate | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Verzenios | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Zoladex | 1 |
| Synopsis of the protocol (for publication) | D1_layperson protocol synopsis_public | 1.1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-29 | Spain | Acceptable 2025-12-26
|
2025-12-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-10 | Spain | Acceptable | 2026-03-11 |