Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
8,000
Countries
1
Sites
66
Patients with invasive breast cancer in early stages
To describe the long-term evolution of the patients with invasive breast cancer in early stages included in GEICAM neoadjuvant and adjuvant clinical trials. Will be studied the frequency, type and location of the first relapse.
Key facts
- Sponsor
- 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]
- Trial duration
- 10 Jan 2018 → ongoing
- Decision date (initial)
- 2023-07-24
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
External identifiers
- EU CT number
- 2022-502706-33-00
- EudraCT number
- 2017-002850-35
- ClinicalTrials.gov
- NCT03390894
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To describe the long-term evolution of the patients with invasive breast cancer in early stages included in GEICAM neoadjuvant and adjuvant clinical trials. Will be studied the frequency, type and location of the first relapse.
Secondary objectives 4
- Overall survival.
- Disease free survival (in adjuvant patients).
- Event-free survival (in neoadjuvant patients).
- Cause of death.
Conditions and MedDRA coding
Patients with invasive breast cancer in early stages
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patients included in neoadjuvant and adjuvant clinical trials with GEICAM's participation. If any of these patients had taken part or is participating in another clinical trial, she/he is eligible for this trial and her/his information will also be collected.
- Patients whose death or contact loss has not been previously collected in the databases of the original studies.
Exclusion criteria 1
- Patients who were not included in the analyses of the original studies due to non-compliance of the eligibility criteria or the original study informed consent withdrawal.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Dates of disease relapse (local, regional or distant) and second primary tumors. Event Free Survival (EvFS) in neoadjuvant studies. Event Free Survival (EFS) in adjuvant studies.
Secondary endpoints 1
- Death date and whether or not it is related to breast cancer. Overall Survival (OS).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
Gemcitabina Accord 2000 mg polvo para solución para perfusión
PRD391152 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 74479
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
PRD2005411 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 24 mg/ml milligram(s)/millilitre
- Max total dose
- 24 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- PA2315/080/001
- MA holder
- ACCORD HEALTHCARE IRELAND LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Abraxane 5 mg/ml powder for dispersion for infusion.
PRD9254301 · Product
- Active substance
- Paclitaxel Albumin-Bound
- Substance synonyms
- PACLITAXEL ALBUMINE-BOUND
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 150 mg/ml milligram(s)/millilitre
- Max total dose
- 150 mg/ml milligram(s)/millilitre
- Max treatment duration
- 112 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- EU/1/07/428/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25379 · Substance
- Active substance
- Lapatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1250 mg milligram(s)
- Max total dose
- 1250 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2386450 · Product
- Active substance
- Nintedanib
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XE31 — -
- Marketing authorisation
- EU/1/14/979/002
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Faslodex 250 mg solution for injection.
PRD3545745 · Product
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 250 mg/ml milligram(s)/millilitre
- Max total dose
- 250 mg/ml milligram(s)/millilitre
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BA03 — FULVESTRANT
- Marketing authorisation
- EU/1/03/269/001
- MA holder
- ASTRAZENECA AB
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Aromasil 25 mg comprimidos recubiertos
PRD422743 · Product
- Active substance
- Exemestane
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 4500 mg milligram(s)
- Max total dose
- 4500 mg milligram(s)
- Max treatment duration
- 6 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
Zoladex 3,6 mg implante en jeringa precargada
PRD395501 · Product
- Active substance
- Goserelin Acetate
- Pharmaceutical form
- IMPLANT
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 21.6 mg milligram(s)
- Max total dose
- 21.6 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02AE03 — GOSERELIN
- Marketing authorisation
- 58.603
- MA holder
- ASTRAZENECA FARMACÉUTICA SPAIN, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paclitaxel Hospira 6 mg/ml concentrado para solución para perfusión EFG
PRD4452147 · Product
- Active substance
- Paclitaxel
- Substance synonyms
- ONCOGEL, ABI-007, MBT 0206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 150 mg/ml milligram(s)/millilitre
- Max total dose
- 150 mg/ml milligram(s)/millilitre
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 66.311
- MA holder
- HOSPIRA INVICTA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion
PRD586554 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 75 mg/ml milligram(s)/millilitre
- Max total dose
- 75 mg/ml milligram(s)/millilitre
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/95/002/001
- MA holder
- SANOFI MATURE IP
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion.
PRD4175808 · Product
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- EU/1/00/141/002
- MA holder
- TEVA B.V
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xeloda 500 mg film-coated tablets
PRD9863934 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- EU/1/00/163/002
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Herceptin 150 mg powder for concentrate for solution for infusion
PRD2154035 · Product
- Active substance
- Trastuzumab
- Substance synonyms
- PF-05280014, TX05, ABP-980, SYD-977
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC03 — TRASTUZUMAB
- Marketing authorisation
- EU/1/00/145/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Grupo Espanol De Investigacion En Cancer De Mama
- Sponsor organisation
- Grupo Espanol De Investigacion En Cancer De Mama
- Address
- Avenida De 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
- Grupo Espanol De Investigacion En Cancer De Mama
- Contact name
- Start Up Unit Manager
Public contact point
- Organisation
- Grupo Espanol De Investigacion En Cancer De Mama
- Contact name
- Start Up Unit Manager
Locations
1 EU/EEA country · 66 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 8,000 | 66 |
| Rest of world | — | 0 | — |
Investigational sites
Complejo Hospitalario Universitario De Ourense
Oncology, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Universitario De Cruces
Oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital De Jerez De La Frontera
Oncology, Carretera De La Ronda Circunvalacion S/n, 11408, Jerez De La Frontera
Hospital Universitario De Toledo Ute
Oncology, Avenida Río Guadiana Sn, 45007, Toledo
Hospital Universitario De La Princesa
Oncology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Clinico San Cecilio
Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital General Universitario De Elche
Oncology, Edificio 2, Camino De La Almazara 11, Elche
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Araba University Hospital
Oncology, Jose Atxotegui S/n, 09010, Vitoria
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario de Móstoles
Oncology, Calle Doctor Luis Montes s/n, 28935, Madrid
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/n, 29010, Malaga
Hospital General Universitario De Elda Virgen De La Salud
Oncology, Carretera De Sax S/n, 03600, Elda
Fundacio Assistencial De Mutua De Terrassa Fpc
Oncology, Calle De San Antonio No 32, 08221, Terrassa
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Dr Peset Aleixandre
Oncology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Universitario De Fuenlabrada
Oncology, Camino Del Molino 2, 28942, Fuenlabrada
Hospital Universitario De Salamanca
Oncology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital General Universitario Dr. Balmis
Oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario Fundacion Alcorcon
Oncology, Calle Budapest 1, 28022, Madrid
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera De Cartagena S/n, El Palmar, Murcia
Hospital Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario La Paz
Oncology, Paseo Castellana 261, 28046, Madrid
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital De Sagunto
Oncology, Calle De Ramon Y Cajal 46, 46520, Sagunto
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Oncology, Rua Doctor Camilo Veiras 1, 15009, A Coruna
Complexo Hospitalario Universitario De Vigo
Oncology, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital General Universitario De Albacete
Oncology, Calle Hermanos Falco 37, 02006, Albacete
Hospital Universitario Lucus Augusti
Oncology, Calle Ulises Romero 1, 27003, Lugo
Hospital Universitario Puerta Del Mar
Oncology, Avenida De Ana De Viya 21, 11009, Cadiz
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Consorcio Hospitalario Provincial De Castellon
Oncology, Avinguda Del Doctor Clara 19, 12006, Castello De La Plana
Hospital Universitario Juan Ramon Jimenez
Oncology, Ronda Exterior Norte S/n, 21005, Huelva
Hospital Universitario Basurto
Oncology, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Clinico Universitario Lozano Blesa
Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Leon University Hospital
Oncology, C Altos De Nava S/n, 24071, Leon
Hospital General Universitario De Guadalajara Sescam
Oncology, Calle De Los Donantes De Sangre Sn, 19002, Guadalajara
Hospital Universitario De Burgos
Oncology, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Virgen de La Luz
Oncology, Calle Hermandad de Donantes de Sangre, 1, Cuenca
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Infanta Cristina
Oncology, Avenida Elvas S/n, 06006, Badajoz
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Fundacion Instituto Valenciano De Oncologia
Oncology, Calle Professor Beltran Baguena 8, 46009, Valencia
Institut Catala D'oncologia
Oncology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Donostia
Oncology, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario Virgen De Valme
Oncology, Avenida Bellavista S/n, 41014, Sevilla
Institut Catala D'oncologia
Oncology, Avinguda De Franca S/n, 17007, Girona
Hospital Universitario Virgen De Las Nieves
Oncology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Oncology, Dr Joan Soler 1-3, 08243, Manresa
Hospital Universitario Severo Ochoa
Oncology, Avenida Orellana S/n, 28911, Leganes
Hospital San Agustín de Avilés
Oncology, Camino de Heros, 6, Avilés (Asturias)
Hospital General Universitario Morales Meseguer
Oncology, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Fundacion Onkologikoa Fundazioa
Oncology, Pasealeku Doct. Begiristain 121, 20014, Donostia
Consorcio Hospital General Universitario De Valencia
Oncology, Provincial De Castellon, Avinguda Del Doctor Clara 19, Castello De La Plana
Consorci Sanitari De Terrassa
Oncology, Carretera Torrebonica Sn, 08227, Terrassa
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos S N, 29010, Malaga
Hospital Virgen De Los Lirios
Oncology, Calle Caramanxel S/n, 03804, Alcoy
Hospital Unviersitario Miguel Servet
Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Salut Sant Joan De Reus
Oncology, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Hospital Arnau De Vilanova De Valencia
Oncology, Calle De San Clemente 12, 46015, Valencia
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2018-01-10 | 2018-01-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_tracked changes_Public | 2.0 TC |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-14 | Spain | Acceptable 2023-07-24
|
2023-07-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-30 | Spain | Acceptable 2024-01-29
|
2024-02-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-03 | Spain | Acceptable | 2024-05-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-08 | Spain | Acceptable | 2024-10-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-09 | Spain | Acceptable | 2025-07-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-11 | Spain | Acceptable | 2026-02-25 |