Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors

What Was Tested

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

Initially, patients receive endocrine treatment for 4 weeks.

It had three arms (groups): A: Endocrine treatment (active comparator), B: Endocrine treatment + palbociclib (experimental) and C: Endocrine treatment + palbociclib (experimental).

Pre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women); postmenopausal women receive an aromatase inhibitor. The preoperative treatment is continued for further 12 weeks, provided that re-evaluation after 6 weeks, week 10 of the preoperative treatment, does not indicate progression. Upon progression (PD), individualized management, preferentially surgery, is the primary option.

The registry classes the interventions as drug.

More on the Plan

Pre- or perimenopausal women are treated with tamoxifen, alternatively with an LHRH analogue in combination with an aromatase inhibitor (only women).

Postmenopausal women receive an aromatase inhibitor.This treatment is given for 4 weeks.

In cases with uncertain menopausal status (previous hysterectomy and equivocal gonadotropins), postmenopause age limit is defined as 55 years or older.

Ki67 is determined by FNA or core biopsy before start and after 2 weeks of treatment.

Who Took Part

The registry lists 10 actual participants took part.

It was open to women only aged from 41 years with no upper age limit.

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

Examples of who could join: Written informed consent. Female patients with non-lobular breast cancer confirmed by histology. Age older than 40 years. Primary breast cancer \>20mm without lymph node metastases. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: metastases, including node metastases in the ipsilateral and/or contralateral thoracic region or in the mediastinum; other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or cis of the cervix; age ≤40 years.

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 Goserelin and who got the comparison, which limits bias.

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

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

It started in 2015-10 with completion listed for 2019-02.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clinical and Radiological Response (time frame: After 16 weeks of preoperative treatment).

It also tracked 10 secondary outcomes, for example Pathological Evaluation of Tumor Response, Disease-free Survival, Breast Cancer-specific Survival, Overall Survival, Incidence of treatment-emergent adverse events [Safety and Tolerability] and Health-related Quality of Life.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 10 people.

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

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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