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Evaluating chemotherapy sequences for advanced HER2-negative breast cancer

NEOSAMBA Clinical Trial - Stage I

Phase 3 Interventional Latin American Cooperative Oncology Group · NCT04540692

This study is testing which order of chemotherapy drugs works best for women with advanced HER2-negative breast cancer to help them feel better and improve their treatment outcomes.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment444 (estimated)
Ages18 Years and up
SexFemale
SponsorLatin American Cooperative Oncology Group Academic / other
Drugs / interventionschemotherapy
Locations18 sites (Cachoeiro de Itapemirim, Espírito Santo and 17 other locations)
Trial IDNCT04540692 on ClinicalTrials.gov

What this trial studies

This phase III randomized clinical trial aims to evaluate the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer. A total of 494 female participants will be randomized into two groups, receiving either anthracycline or taxane first, with the option of adding carboplatin for those with triple-negative subtypes. The chemotherapy regimens will follow institutional protocols, while subsequent treatments like surgery and radiotherapy will adhere to standard guidelines. The study seeks to determine the most effective sequence of chemotherapy agents to improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 and older with invasive breast carcinoma stages IIB to III and HER2-negative status.

Not a fit: Patients with HER2-positive breast cancer or those with earlier stages of breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with locally advanced HER2-negative breast cancer.

How similar studies have performed: Other studies have explored chemotherapy sequencing, but this specific approach in the context of HER2-negative breast cancer is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Cachoeiro de Itapemirim, Espírito Santo and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.