Anthracyclines and Taxanes for Advanced Breast Cancer
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
Recruiting
Phase 3Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
444 (estimated)
Sponsor
Latin American Cooperative Oncology Group · Other
Who this trial is looking for
This trial is looking for women with HER2-negative breast cancer to test different treatment sequences. Participants will receive neoadjuvant therapy, which is given before surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman at least 18 years old.
I have been diagnosed with invasive breast cancer.
I have HER2-negative breast cancer.
I am willing to use contraception during and after treatment.
I have a good level of physical function.
I have adequate organ function.
I have had a heart check that shows I have good cardiac function.
You may not be able to join if
I do not meet the inclusion criteria mentioned.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.
Trial Locations
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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 (wit…
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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