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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Docetaxel or Paclitaxel
Cyclophosphamide + Doxorrubicin
Sponsored by
Latin American Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo JorgeRecruiting
  • ICTr
  • Hospital Jardim AmáliaRecruiting
  • Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o CâncerRecruiting
  • Hospital de Clínicas de Porto AlegreRecruiting
  • Centro de Pesquisa em Oncologia PUCRS
  • Centro de Pesquisas Oncológicas - CEPONRecruiting
  • Hospital de Câncer de BarretosRecruiting
  • IBCCRecruiting
  • ICESP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Start with Cyclophosphamide + Doxorrubicin

Start with Docetaxel or Paclitaxel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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..

Secondary Outcome Measures

Full Information

First Posted
August 11, 2020
Last Updated
January 5, 2023
Sponsor
Latin American Cooperative Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT04540692
Brief Title
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
Acronym
NEOSAMBA
Official Title
Phase III Randomized Clinical Trial Evaluating the Sequencing of Anthracyclines and Taxanes in Neoadjuvant Therapy for Locally Advanced HER2-negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
October 12, 2023 (Anticipated)
Study Completion Date
August 23, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Latin American Cooperative Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
494 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Start with Cyclophosphamide + Doxorrubicin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Start with Docetaxel or Paclitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel or Paclitaxel
Other Intervention Name(s)
Taxotere or Taxol
Intervention Description
Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide + Doxorrubicin
Other Intervention Name(s)
Citoxan + Rubidox
Intervention Description
Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
Primary Outcome Measure Information:
Title
Invasive disease-free survival (IDFS)
Description
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..
Time Frame
An average of 8 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
José Bines, MD
Phone
+55 21 3207-3810
Email
jose_bines@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gustavo Werutsky, MD
Phone
+55 51 3384-5334
Email
gustavo.werutsky@lacog.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Bines, MD
Organizational Affiliation
Instituto Nacional do Câncer - INCA - HCIII
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gustavo Werutsky, MD
Organizational Affiliation
Latin American Cooperative Oncology Group
Official's Role
Study Chair
Facility Information:
Facility Name
Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo Jorge
City
Goiânia
State/Province
Goiás
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geraldo Queiroz, MD
Facility Name
ICTr
City
Curitiba
State/Province
Paraná
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriano Silva
Facility Name
Hospital Jardim Amália
City
Volta Redonda
State/Province
Rio De Janeiro
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviane Lima
First Name & Middle Initial & Last Name & Degree
Heloísa Resende, MD
Facility Name
Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer
City
Natal
State/Province
Rio Grande Do Norte
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Emerenciano, MD
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Liedke, MD
Facility Name
Centro de Pesquisa em Oncologia PUCRS
City
Porto Alegre
State/Province
RS
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Centro de Pesquisas Oncológicas - CEPON
City
Florianópolis
State/Province
Santa Catarina
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeni Veronica Nerón, MD
Facility Name
Hospital de Câncer de Barretos
City
Barretos
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Camila Alfano
First Name & Middle Initial & Last Name & Degree
Ricardo Zylberberg
Facility Name
IBCC
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana Fenerich Mauri
First Name & Middle Initial & Last Name & Degree
Felipe Jose Silva Melo Cruz
Facility Name
ICESP
City
São Paulo
Country
Brazil
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Learn more about this trial

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

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