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Can the sequence of chemo drugs tip the scales in HER2-negative breast cancer?

NCT ID NCT04540692

Disease control Sponsor: Latin American Cooperative Oncology Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether giving one type of chemotherapy before another, before surgery, changes the chances of staying cancer-free in people with locally advanced HER2-negative breast cancer. Participants receive either a taxane (docetaxel or paclitaxel) first, followed by an anthracycline combination (cyclophosphamide plus doxorubicin), or the reverse order. The study tracks how long people live without invasive cancer returning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chemotherapy drugs docetaxel or paclitaxel, and cyclophosphamide plus doxorubicin
What this could lead to
If one sequence works better, it could improve long-term survival for people with locally advanced HER2-negative breast cancer and set a new standard for neoadjuvant therapy.
What could go wrong
This is a large Phase 3 trial, but the outcome depends on many factors, and the benefit of one sequence over the other may be small. Chemotherapy carries side effects like fatigue, nausea, and risk of infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

446 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Her2-receptor negative breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • CEPON - Centro de Pesquisas Oncológicas

    Florianópolis, Santa Catarina, 88.034-000, Brazil

  • Centro de Pesquisa do Hospital Araújo Jorge

    Goiânia, Goiás, 74.605-010, Brazil

  • Faculdade de Ciências Médicas da Unicamp

    Campinas, São Paulo, 13.083-881, Brazil

  • HCPA - Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil

  • HFOA - Hospital da Fundação Oswaldo Aranha

    Volta Redonda, Rio de Janeiro, 27.251-260, Brazil

  • HUEM/CEON - Hospital Universitário Evangélico Mackenzie

    Curitiba, Paraná, 80.730-150, Brazil

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81.520-060, Brazil

  • Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)

    Cachoeiro de Itapemirim, Espírito Santo, 29.308-065, Brazil

  • Hospital de Amor Jales - Hospital de Câncer de Barretos

    Jales, São Paulo, 15.706-396, Brazil

  • Hospital de Amor de Barretos

    Barretos, São Paulo, 14.784-400, Brazil

  • IBCC Oncologia - Núcleo de Pesquisa São Camilo

    São Paulo, São Paulo, 04.014-002, Brazil

  • ICTR - Instituto do Câncer e Transplante de Curitiba

    Curitiba, Paraná, 80.510-130, Brazil

  • IMIP - Instituto de Medicina Integral Professor Fernando Figueira

    Recife, Pernambuco, 50.070-902, Brazil

  • INCA - Instituto Nacional de Câncer

    Rio de Janeiro, Rio de Janeiro, 20.230-130, Brazil

  • Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel

    Salvador, Estado de Bahia, 400.50-410, Brazil

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)

    Botucatu, São Paulo, 18.618-686, Brazil

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