Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer

What Was Tested

In this not phased trial, researchers set out to test Goserelin.

It had two arms (groups): Triple-negative Breast Cancer with Non-immunomodulatory Subtype (experimental) and Hormone Receptor-positive (HR+) and HER2-negative (HER2-) (experimental).

The registry classes the interventions as combination product.

More on the Plan

Local tumor destruction with non-surgical ablation (NSA, cryoablation or radiofrequency) induces inflammation and releases antigens that can activate tumor-specific immune responses.

In this pilot study, patients with operable HER2-negative breast cancer were designed to receive a combination of MTT, immunotherapy and neoadjuvant chemotherapy.

Potential favorable intra-tumoral and systemic immunologic effects were assessed with the combination, revealing the possibility for induced and synergistic anti-tumor immunity with this strategy.

Who Took Part

The registry lists 14 actual participants took part.

It was open to women only aged from 18 years up to 70 years.

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

Examples of who could join: Female，age 18-70 years. Histologically confirmed invasive cancer of the breast, and patients meeting cT2-4N+M0 criteria;. TNBC non-immunoregulation subtype or HR+/HER2- status were measured by immunohistochemistry (IHC);. At least one measurable lesion according to RECIST 1.1 criteria;. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;.

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;; patients with new york heart association (nyha) grade ii or above heart disease (including grade ii);; patients with severe systemic infections or other serious diseases;.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Goserelin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

It started in 2024-12-23 with completion listed for 2026-01-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Assessment of immune activating response (time frame: up to 28 weeks).

It also tracked 1 secondary outcome, for example CTCAE scale (V4.0).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Goserelin in 14 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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