Breast CancerPhase 3NEOSAMBANCT04540692
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
A Phase 3 study testing Docetaxel or Paclitaxel and Cyclophosphamide + Doxorrubicin in people with Breast Cancer, run by Latin American Cooperative Oncology Group at 16 sites in Brazil.
Trial summary
Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel or Paclitaxel and Cyclophosphamide + Doxorrubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 16 sitesBrazil
- Study dates
- 12 Jan 2021to Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals who do not meet the inclusion criteria above-mentioned.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Brazil16 sites
Hospital de Amor de Barretos
Barretos, São Paulo, 14.784-400
UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)
Botucatu, São Paulo, 18.618-686
Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
Cachoeiro de Itapemirim, Espírito Santo, 29.308-065
Faculdade de Ciências Médicas da Unicamp
Campinas, São Paulo, 13.083-881
ICTR - Instituto do Câncer e Transplante de Curitiba
Curitiba, Paraná, 80.510-130
HUEM/CEON - Hospital Universitário Evangélico Mackenzie
Curitiba, Paraná, 80.730-150
Hospital Erasto Gaertner
Curitiba, Paraná, 81.520-060
CEPON - Centro de Pesquisas Oncológicas
Florianópolis, Santa Catarina, 88.034-000
Centro de Pesquisa do Hospital Araújo Jorge
Goiânia, Goiás, 74.605-010
Hospital de Amor Jales - Hospital de Câncer de Barretos
Jales, São Paulo, 15.706-396
HCPA - Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50.070-902
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro, 20.230-130
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel
Salvador, Estado de Bahia, 400.50-410
IBCC Oncologia - Núcleo de Pesquisa São Camilo
São Paulo, São Paulo, 04.014-002
HFOA - Hospital da Fundação Oswaldo Aranha
Volta Redonda, Rio de Janeiro, 27.251-260
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel or Paclitaxel, Cyclophosphamide + Doxorrubicin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel or PaclitaxelDrug
Also called Taxotere or Taxol
Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks
Cyclophosphamide + DoxorrubicinDrug
Also called Citoxan + Rubidox
Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Start with Cyclophosphamide + Doxorrubicin | Active comparator | 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. Receives: Drug: Cyclophosphamide + Doxorrubicin |
| Start with Docetaxel or Paclitaxel | Experimental | 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. Receives: Drug: Docetaxel or Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: An average of 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start12 Jan 2021
- Primary completionApr 2027 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
- Responsible party
- Sponsor
- Investigators
- José Bines, Principal investigator, Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540692
- Sponsor's protocol ID
- GBECAM 0419
- Other IDs
- LACOG 0419
- Acronym
- NEOSAMBA
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2020
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEOSAMBA Clinical Trial - Stage I
- ClinicalTrials.gov ID
- NCT04540692
- Acronym / sponsor ID
- NEOSAMBA / GBECAM 0419
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Start with Cyclophosphamide + Doxorrubicin | Active comparator | Drug: Cyclophosphamide + DoxorrubicinPatients 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. |
| Start with Docetaxel or Paclitaxel | Experimental | Drug: Docetaxel or PaclitaxelPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals who do not meet the inclusion criteria above-mentioned.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel or PaclitaxelAlso: Taxotere or TaxolTreatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks | Drug | Start with Docetaxel or Paclitaxel |
| Cyclophosphamide + DoxorrubicinAlso: Citoxan + RubidoxTreatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles | Drug | Start with Cyclophosphamide + Doxorrubicin |
Primary outcome
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..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Bines principal investigator
Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel or Paclitaxel and Cyclophosphamide + Doxorrubicin in people with Breast Cancer, run by Latin American Cooperative Oncology Group at 16 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease-free survival (IDFS) (time frame: An average of 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.