Clinical trial NCT04540692: Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
Official title: NEOSAMBA Clinical Trial - Stage I
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
First posted: 2020-09-07
Enrollment: 444
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.

Detailed description: Multicenter, phase III, open-label, randomized clinical trial, which will include 494 patients randomized to two neoadjuvant chemotherapy arms. The treatment protocol will be the same in both groups, only the regimens sequences will be evaluated: starting with anthracycline versus taxane, with or without carboplatin for patients with triple negative subtype. The chemotherapy regimen will follow the institution's routine, which includes the use of CA in the anthracyclical phase and, in the taxane phase, the use of docetaxel every 21 days or weekly paclitaxel. The rest of the treatment (surgery, radiotherapy, hormone therapy) will not be part of the study and will be carried out according to institutional guidelines.

Eligibility criteria: Inclusion Criteria:

* 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 a functional capacity according to the Eastern Cooperative Oncology Group (ECOG) from 0 to 2. The evaluation of the ECOG must be carried out within 7 days before the inclusion date.
* 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.

Exclusion Criteria:

- Individuals who do not meet the inclusion criteria above-mentioned.

Primary outcomes:
measure: Invasive disease-free survival (IDFS)
timeFrame: An average of 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel
state: Bahia
city: Cachoeiro De Itapemirim
country: Brazil
facility: Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
state: Espírito Santo
city: Goiânia
country: Brazil
facility: Centro de Pesquisa do Hospital Araújo Jorge
state: Goiás
city: Curitiba
country: Brazil
facility: ICTR - Instituto do Câncer e Transplante de Curitiba
state: Paraná
city: Curitiba
country: Brazil
facility: HUEM/CEON - Hospital Universitário Evangélico Mackenzie
state: Paraná
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Paraná
city: Recife
country: Brazil
facility: IMIP - Instituto de Medicina Integral Professor Fernando Figueira
state: Pernambuco
city: Recife
country: Brazil
facility: Hospital Universitário Oswaldo Cruz (UNIPECLIN)
state: Pernambuco
city: Volta Redonda
country: Brazil
facility: HINJA - Hospital Jardim Amália
state: Rio De Janeiro
city: Porto Alegre
country: Brazil
facility: HCPA - Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: CEPON - Centro de Pesquisas Oncológicas
state: Santa Catarina
city: Barretos
country: Brazil
facility: Hospital de Amor de Barretos
state: São Paulo
city: Botucatu
country: Brazil
facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)
state: São Paulo
city: Campinas
country: Brazil
facility: Faculdade de Ciências Médicas da Unicamp
state: São Paulo
city: Jales
country: Brazil
facility: Hospital de Amor Jales - Hospital de Câncer de Barretos
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: INCA - Instituto Nacional de Câncer
city: São Paulo
country: Brazil
facility: ICESP - Instituto do Câncer do Estado de São Paulo
city: São Paulo
country: Brazil
facility: IBCC Oncologia - Núcleo de Pesquisa São Camilo
Study officials:
affiliation: Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
name: José Bines
role: PRINCIPAL_INVESTIGATOR
References: