Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Docetaxel or Paclitaxel, Cyclophosphamide + Doxorrubicin.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NEOSAMBA Clinical Trial - Stage I
Overview
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.
Interventions
- 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 - Drug Cyclophosphamide + Doxorrubicin
Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
Primary outcome measures
- Invasive disease-free survival (IDFS) [Time frame: An average of 8 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 18 centers
- Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia — Cachoeiro de Itapemirim
- Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel — Salvador
- Centro de Pesquisa do Hospital Araújo Jorge — Goiânia
- ICTR - Instituto do Câncer e Transplante de Curitiba — Curitiba
- HUEM/CEON - Hospital Universitário Evangélico Mackenzie — Curitiba
- Hospital Erasto Gaertner — Curitiba
- IMIP - Instituto de Medicina Integral Professor Fernando Figueira — Recife
- Hospital Universitário Oswaldo Cruz (UNIPECLIN) — Recife
- … and 10 more centers
Identifiers
NCT: NCT04540692 · GBECAM 0419 · LACOG 0419