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

June 3, 2024 updated by: Latin American Cooperative Oncology Group

NEOSAMBA Clinical Trial - Stage I

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
444

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 20.230-130
        • Recruiting
        • INCA - Instituto Nacional de Cancer
        • Principal Investigator:
          • Rodrigo Moura Araújo
      • São Paulo, Brazil, 01.246-000
        • Recruiting
        • Icesp - Instituto Do Câncer Do Estado de São Paulo
        • Principal Investigator:
          • Laura Testa
      • São Paulo, Brazil, 04.014-002
        • Recruiting
        • IBCC Oncologia - Núcleo de Pesquisa São Camilo
        • Principal Investigator:
          • Lilian Arruda do Rêgo Barros
    • Bahia
      • Salvador, Bahia, Brazil, 400.50-410
        • Recruiting
        • Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel
        • Principal Investigator:
          • Daniela Galvão Barros de Oliveira
    • Espírito Santo
      • Cachoeiro De Itapemirim, Espírito Santo, Brazil, 29.308-065
        • Recruiting
        • Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
        • Principal Investigator:
          • Sabina Bandeira Aleixo
    • Goiás
      • Goiânia, Goiás, Brazil, 74.605-010
        • Recruiting
        • Centro de Pesquisa do Hospital Araújo Jorge
        • Principal Investigator:
          • Geraldo Silva Queiroz
    • Paraná
      • Curitiba, Paraná, Brazil, 80.510-130
        • Recruiting
        • ICTR - Instituto do Câncer e Transplante de Curitiba
        • Principal Investigator:
          • Gisah Guilgen
      • Curitiba, Paraná, Brazil, 80.730-150
        • Recruiting
        • HUEM/CEON - Hospital Universitário Evangélico Mackenzie
        • Principal Investigator:
          • Maria Cristina Figueroa Magalhães
      • Curitiba, Paraná, Brazil, 81.520-060
        • Recruiting
        • Hospital Erasto Gaertner
        • Principal Investigator:
          • João Soares Nunes
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50.070-902
        • Recruiting
        • IMIP - Instituto de Medicina Integral Professor Fernando Figueira
        • Principal Investigator:
          • Andréa Lopes Ponte de Souza
      • Recife, Pernambuco, Brazil, 50.110-130
        • Recruiting
        • Hospital Universitário Oswaldo Cruz (UNIPECLIN)
        • Principal Investigator:
          • Thiago Lourenço Apolinário
    • Rio De Janeiro
      • Volta Redonda, Rio De Janeiro, Brazil, 27.251-260
        • Recruiting
        • HINJA - Hospital Jardim Amália
        • Principal Investigator:
          • Heloísa Magda Resende
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.035-903
        • Recruiting
        • HCPA - Hospital de Clinicas de Porto Alegre
        • Principal Investigator:
          • Pedro Emanuel Rubini Liedke
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88.034-000
        • Recruiting
        • CEPON - Centro de Pesquisas Oncologicas
        • Principal Investigator:
          • Yeni Verônica Nerón
    • São Paulo
      • Barretos, São Paulo, Brazil, 14.784-400
        • Recruiting
        • Hospital de Amor de Barretos
        • Principal Investigator:
          • Cristiano de Pádua Souza
      • Botucatu, São Paulo, Brazil, 18.618-686
        • Recruiting
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)
        • Principal Investigator:
          • Ana Lucia Coradazzi
      • Campinas, São Paulo, Brazil, 13.083-881
        • Recruiting
        • Faculdade de Ciências Médicas da Unicamp
        • Principal Investigator:
          • Susana Oliveira Botelho Ramalho
      • Jales, São Paulo, Brazil, 15.706-396
        • Recruiting
        • Hospital de Amor Jales - Hospital de Câncer de Barretos
        • Principal Investigator:
          • Túlio Samara Rodrigues de Almeida Lucas Furquim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Start with Cyclophosphamide + Doxorrubicin
Patients 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.
Drug: Cyclophosphamide + Doxorrubicin
Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
Other Names:
  • Citoxan + Rubidox
Experimental: Start with Docetaxel or Paclitaxel
Patients 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.
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
Other Names:
  • Taxotere or Taxol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Invasive disease-free survival (IDFS)
Time Frame: An average of 8 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Latin American Cooperative Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: José Bines, Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GBECAM 0419
  • LACOG 0419 (Other Identifier: LACOG)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Cyclophosphamide + Doxorrubicin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings