The Neoadjuvant Combined Hormone Therapy in Premenopausal Women With Locally Advanced ER+/HER2- Breast Cancer

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Triptorelin.

Breast cancer take a leading position in the structure of morbidity and mortality from malignant tumors among women.

While the researchers obtain little experimental data and practical research about the treatment of locally advanced forms.

It had two arms (groups): Neoadjuvant combined hormone therapy (experimental) and Chemotherapy (the control) (active comparator).

Ribocyclib, fulvestrant, triptorelin.

Doxorubicin, cyclophosphamide, paclitaxel.

The registry classes the interventions as drug.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to women only aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years. Women with a newly diagnosed breast cancer who have not previously received specific treatment, with a tumor stage: cT1-3N1-2M0. The consent of the patient to carry out, if possible, organ-preserving surgery with previous radiation therapy. Adequate Bone Marrow Function including:. Adequate Liver Function, including all of the following parameters:.

The full record lists 14 inclusion and 5 exclusion criteria; among the exclusions: HIV positive status; known hypersensitivity to study drugs or excipients; pregnancy and lactation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-01-28 with completion listed for 2023-01-28.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: frequency of objective response (time frame: 24 weeks). complete pathomorphological response (time frame: 24 weeks).

It also tracked 3 secondary outcomes, for example change of the Ki67 level in postoperative material compared to primary biopsy, the frequency of organ-preserving operation after neoadjuvant treatment and quality of life.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Triptorelin in 120 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.