Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
NEOSAMBA
NEOSAMBA Clinical Trial - Stage I
2 other identifiers
interventional
444
1 country
18
Brief Summary
Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jan 2021
Typical duration for phase_3 breast-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedStudy Start
First participant enrolled
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
ExpectedJune 4, 2024
June 1, 2024
5.2 years
August 11, 2020
June 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Invasive disease-free survival (IDFS)
Defined as the time elapsed between the date of randomization and the date of invasive recurrence (excludes carcinoma in situ) or death, whichever comes first..
An average of 8 years
Study Arms (2)
Start with Cyclophosphamide + Doxorrubicin
ACTIVE COMPARATORPatients will receive the following treatment schedule: Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles, followed by docetaxel 75-100mg/m2 intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m2 for 12 weeks.
Start with Docetaxel or Paclitaxel
EXPERIMENTALPatients will receive the following treatment schedule: Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks, followed by Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days, for 3 cycles.
Interventions
Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks
Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
Eligibility Criteria
You may qualify if:
- Female participants, with at least 18 years old on the day of signing the free and informed consent;
- Invasive breast carcinoma stage III (RH positive) or IIB/III (RH negative), according to TNM 8th edition; Histologically confirmed diagnosis of invasive breast carcinoma (with any histology), HER-2 negative;
- The participant (or legally acceptable representative, if applicable) provides written informed consent for the study;
- The participant must agree to use a contraceptive as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of the study treatment;
- Have adequate organic function. The samples must be collected within 60 days before the start of the study treatment;
- Have adequate cardiac function as assessed by echocardiogram or MUGA performed up to 60 days before the start of treatment under study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
Cachoeiro de Itapemirim, Espírito Santo, 29.308-065, Brazil
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel
Salvador, Estado de Bahia, 400.50-410, Brazil
Centro de Pesquisa do Hospital Araújo Jorge
Goiânia, Goiás, 74.605-010, Brazil
ICTR - Instituto do Câncer e Transplante de Curitiba
Curitiba, Paraná, 80.510-130, Brazil
HUEM/CEON - Hospital Universitário Evangélico Mackenzie
Curitiba, Paraná, 80.730-150, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, 81.520-060, Brazil
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50.070-902, Brazil
Hospital Universitário Oswaldo Cruz (UNIPECLIN)
Recife, Pernambuco, 50.110-130, Brazil
HINJA - Hospital Jardim Amália
Volta Redonda, Rio de Janeiro, 27.251-260, Brazil
HCPA - Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil
CEPON - Centro de Pesquisas Oncológicas
Florianópolis, Santa Catarina, 88.034-000, Brazil
Hospital de Amor de Barretos
Barretos, São Paulo, 14.784-400, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)
Botucatu, São Paulo, 18.618-686, Brazil
Faculdade de Ciências Médicas da Unicamp
Campinas, São Paulo, 13.083-881, Brazil
Hospital de Amor Jales - Hospital de Câncer de Barretos
Jales, São Paulo, 15.706-396, Brazil
INCA - Instituto Nacional de Câncer
Rio de Janeiro, 20.230-130, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo
São Paulo, 01.246-000, Brazil
IBCC Oncologia - Núcleo de Pesquisa São Camilo
São Paulo, 04.014-002, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Bines
Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
September 7, 2020
Study Start
January 12, 2021
Primary Completion
April 1, 2026
Study Completion (Estimated)
August 1, 2030
Last Updated
June 4, 2024
Record last verified: 2024-06