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

Phase III Randomized Clinical Trial Evaluating the Sequencing of Anthracyclines and Taxanes in Neoadjuvant Therapy for Locally Advanced HER2-negative Breast Cancer

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: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Cyclophosphamide + Doxorrubicin; Drug: Docetaxel or Paclitaxel

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: Interventional
• Enrollment (Estimated): 494
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Diana Rostirolla; Phone Number: +55 51 3384 5334; Email: diana.rostirolla@lacogcancerresearch.org
• Study Contact Backup: Name: Laura Voelcker; Phone Number: +55 51 3384-5334; Email: laura.voelcker@lacogcancerresearch.org

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • IBCC
    • Contact: Juliana Fenerich Mauri
    • Principal Investigator: Felipe Jose Silva Melo Cruz
  • São Paulo, Brazil
    • Withdrawn
    • ICESP
  • Goiás
    • Goiânia, Goiás, Brazil
      • Recruiting
      • Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo Jorge
      • Contact: Geraldo Queiroz, MD
  • Paraná
    • Curitiba, Paraná, Brazil
      • Not yet recruiting
      • ICTr
      • Principal Investigator: Adriano Silva
  • RS
    • Porto Alegre, RS, Brazil
      • Withdrawn
      • Centro de Pesquisa em Oncologia PUCRS
  • Rio De Janeiro
    • Volta Redonda, Rio De Janeiro, Brazil
      • Recruiting
      • Hospital Jardim Amália
      • Contact: Viviane Lima
      • Principal Investigator: Heloísa Resende, MD
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil
      • Recruiting
      • Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer
      • Contact: Karla Emerenciano, MD
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Pedro Liedke, MD
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil
      • Recruiting
      • Centro de Pesquisas Oncológicas - CEPON
      • Contact: Yeni Veronica Nerón, MD
  • São Paulo
    • Barretos, São Paulo, Brazil
      • Recruiting
      • Hospital de Cancer de Barretos
      • Contact: Ana Camila Alfano
      • Principal Investigator: Ricardo Zylberberg

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Collaborators: Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
• Investigators: Principal Investigator: José Bines, Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Docetaxel; Cyclophosphamide; Paclitaxel
• Other Study ID 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