Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer

Breast Cancer Clinical Trial

— NEOSAMBA  

Official title:

NEOSAMBA Clinical Trial - Stage I

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04540692
• Other study ID #: GBECAM 0419
• Secondary ID: LACOG 0419
• Status: Recruiting
• Phase: Phase 3
• Start date: January 12, 2021
• Est. completion date: August 2030

Study information

• Verified date: June 2024
• Source: Latin American Cooperative Oncology Group
• Contact: Diana Rostirolla
• Phone: +55 51 3384 5334
• Email: diana.rostirolla[@]lacogcancerresearch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 444
• Est. completion date: August 2030
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel or Paclitaxel
Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks
• Cyclophosphamide + Doxorrubicin
Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles

Locations

Country	Name	City	State
Brazil	Hospital de Amor de Barretos	Barretos	São Paulo
Brazil	UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)	Botucatu	São Paulo
Brazil	Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)	Cachoeiro De Itapemirim	Espírito Santo
Brazil	Faculdade de Ciências Médicas da Unicamp	Campinas	São Paulo
Brazil	Hospital Erasto Gaertner	Curitiba	Paraná
Brazil	HUEM/CEON - Hospital Universitário Evangélico Mackenzie	Curitiba	Paraná
Brazil	ICTR - Instituto do Câncer e Transplante de Curitiba	Curitiba	Paraná
Brazil	CEPON - Centro de Pesquisas Oncológicas	Florianópolis	Santa Catarina
Brazil	Centro de Pesquisa do Hospital Araújo Jorge	Goiânia	Goiás
Brazil	Hospital de Amor Jales - Hospital de Câncer de Barretos	Jales	São Paulo
Brazil	HCPA - Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Universitário Oswaldo Cruz (UNIPECLIN)	Recife	Pernambuco
Brazil	IMIP - Instituto de Medicina Integral Professor Fernando Figueira	Recife	Pernambuco
Brazil	INCA - Instituto Nacional de Câncer	Rio De Janeiro
Brazil	Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel	Salvador	Bahia
Brazil	IBCC Oncologia - Núcleo de Pesquisa São Camilo	São Paulo
Brazil	ICESP - Instituto do Câncer do Estado de São Paulo	São Paulo
Brazil	HINJA - Hospital Jardim Amália	Volta Redonda	Rio De Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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